None ( DrugBank: - )


16 diseases
告示番号疾患名(ページ内リンク)臨床試験数
6パーキンソン病3
46悪性関節リウマチ14
51全身性強皮症2
65原発性免疫不全症候群7
78下垂体前葉機能低下症9
84サルコイドーシス1
85特発性間質性肺炎2
96クローン病7
97潰瘍性大腸炎2
140ドラベ症候群2
160先天性魚鱗癬1
161家族性良性慢性天疱瘡1
171ウィルソン病4
231α1−アンチトリプシン欠乏症3
271強直性脊椎炎2
299嚢胞性線維症10

6. パーキンソン病


臨床試験数 : 2,298 薬物数 : 2,202 - (DrugBank : 350) / 標的遺伝子数 : 188 - 標的パスウェイ数 : 202
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1ChiCTR2100048680
2021-08-012021-07-12The clinical study on the sedative efficacy and wakefulness of dexmedetomidine in Parkinson's disease patientsThe clinical study on the sedative efficacy and wakefulness of dexmedetomidine in Parkinson's disease patients Parkinson's diseaseExperimental group:An infusion of dexmedetomidine;Control group:None;The First Affiliated Hospital of University of Science and Technology of China (Southern District Phase 2)NULLPending3575BothExperimental group:35;Control group:35;China
2JPRN-jRCTs061180028
11/05/201526/02/2019Pain reduction in PD patients with depression: double blind, randomized clinical trial of duloxetineA double-blind, randomized clinical trial to evaluate the efficacy of Duloxetine against pain associated with Parkinson's disease with depression - Pain reduction in PD patients with depression: double blind, randomized clinical trial of duloxetine Parkinson's disease;D010300The treatment groups consist of an active treatment arm (40mg/day Duloxetine) and a placebo arm. During the Titration Period (2 weeks), all subjects will be started on 1 capsule (10mg or placebo). During the Maintenance Period (10 weeks), subjects will take 2 capsules. Subjects who are unable to increase their dose can stay at 1 capsule.Ando RinaNULLComplete20 years oldNoneBoth50Phase 2Japan
3EUCTR2011-005054-59-RO
(EUCTR)
21/02/201213/06/2013SYN115 in Parkinson’s diseaseA double-blind, randomized, placebo-controlled study of the safety and efficacy of SYN115 as adjunctive therapy in levodopa-treated Parkinson’s subjects with end of dose wearing off - (none) Parkinson’s disease
MedDRA version: 16.0;Level: LLT;Classification code 10013113;Term: Disease Parkinson's;System Organ Class: 100000004852;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: SYN115 Tablets, 60 mg
Product Code: SYN115
INN or Proposed INN: tozadenant
Other descriptive name: tozadenant
Biotie Therapies Inc.NULLNot RecruitingFemale: yes
Male: yes
400United States;Canada;Argentina;Ukraine;Romania;Chile

46. 悪性関節リウマチ


臨床試験数 : 4,325 薬物数 : 2,671 - (DrugBank : 417) / 標的遺伝子数 : 187 - 標的パスウェイ数 : 224
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2012-002181-12-SE
(EUCTR)
19/08/201309/07/2012A Phase IIa POC study to evaluate Safety, Tolerability and Efficacy in Subjects with RAA Phase IIa, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter, Worldwide, Proof-of-Concept Clinical Trial to Evaluate the Safety, Tolerability, and Efficacy of MK-8457 in Subjects with Active Rheumatoid Arthritis and an Inadequate Response or Intolerance to Anti-TNF-a Therapy - A Phase IIa POC study to evaluate Safety, Tolerability and Efficacy in Subjects with RA Active rheumatoid arthritis
MedDRA version: 16.0;Level: PT;Classification code 10039073;Term: Rheumatoid arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: MK-8457
Product Code: MK-8457
INN or Proposed INN: None
Other descriptive name: MK-8457
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (hereafter referred to asNULLNot RecruitingFemale: yes
Male: yes
178Phase 2United States;Greece;Spain;Austria;Colombia;Italy;United Kingdom;France;Hungary;Poland;Brazil;Peru;Australia;Denmark;South Africa;New Zealand;Sweden
2EUCTR2012-000439-17-LT
(EUCTR)
11/05/201215/03/2012A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter,Worldwide, Dose-Ranging Clinical Trial with a Proof-of-Concept Lead Cohort toEvaluate the Safety, Tolerability, and Efficacy of MK-8457 + MTX in Patients withActive Rheumatoid Arthritis Despite Methotrexate TherapyA Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter,Worldwide, Dose-Ranging Clinical Trial with a Proof-of-Concept Lead Cohort toEvaluate the Safety, Tolerability, and Efficacy of MK-8457 + MTX in Patients withActive Rheumatoid Arthritis Despite Methotrexate Therapy - Proof-of-Concept of MK-8457 in patients with Rheumatoid Arthritis active rheumatoid arthritis;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]Product Name: MK-8457
Product Code: MK-8457
INN or Proposed INN: None
Other descriptive name: MK-8457
Product Name: MK-8457
Product Code: MK-8457
INN or Proposed INN: None
Other descriptive name: MK-8457
MERCK SHARP & DOHME CORP.NULLNot RecruitingFemale: yes
Male: yes
342Phase 2United States;Taiwan;Korea, Democratic People's Republic of;Lithuania;Russian Federation;Chile;United Kingdom;India;Hungary;Mexico;Canada;Poland;Brazil;Denmark;Peru;South Africa;Latvia;Germany;Japan;Moldova, Republic of
3EUCTR2009-012705-19-CZ
(EUCTR)
16/10/200917/07/2009A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Determine the Safety and Efficacy of Daily Orally Administered LX3305 in Subjects with Active Rheumatoid Arthritis (RA) on Stable Methotrexate (MTX) Therapy - LX3305.201A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Determine the Safety and Efficacy of Daily Orally Administered LX3305 in Subjects with Active Rheumatoid Arthritis (RA) on Stable Methotrexate (MTX) Therapy - LX3305.201 Rheumatoid Arthritis (RA)
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term:
Product Name: LX3305 Dihydrate
Product Code: LX3305
INN or Proposed INN: None as of yet
Other descriptive name: LX3305
Product Name: LX3305 Dihydrate
Product Code: LX3305
INN or Proposed INN: None as of yet
Other descriptive name: LX3305
Lexicon Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
200Phase 2Hungary;Czech Republic;Bulgaria
4EUCTR2009-012705-19-BG
(EUCTR)
29/09/200906/10/2009A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Determine the Safety and Efficacy of Daily Orally Administered LX3305 in Subjects with Active Rheumatoid Arthritis (RA) on Stable Methotrexate (MTX) Therapy - LX3305.201A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Determine the Safety and Efficacy of Daily Orally Administered LX3305 in Subjects with Active Rheumatoid Arthritis (RA) on Stable Methotrexate (MTX) Therapy - LX3305.201 Rheumatoid Arthritis (RA)
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term:
Product Name: LX3305 Dihydrate
Product Code: LX3305
INN or Proposed INN: None as of yet
Other descriptive name: LX3305
Product Name: LX3305 Dihydrate
Product Code: LX3305
INN or Proposed INN: None as of yet
Other descriptive name: LX3305
Lexicon Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
104Phase 2Hungary;Czech Republic;Bulgaria
5EUCTR2009-012705-19-HU
(EUCTR)
17/08/200916/07/2009A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Determine the Safety and Efficacy of Daily Orally Administered LX3305 in Subjects with Active Rheumatoid Arthritis (RA) on Stable Methotrexate (MTX) Therapy - LX3305.201A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Determine the Safety and Efficacy of Daily Orally Administered LX3305 in Subjects with Active Rheumatoid Arthritis (RA) on Stable Methotrexate (MTX) Therapy - LX3305.201 Rheumatoid Arthritis (RA)
MedDRA version: 12.0;Level: LLT;Classification code 10039073;Term:
Product Name: LX3305 Dihydrate
Product Code: LX3305
INN or Proposed INN: None as of yet
Other descriptive name: LX3305
Product Name: LX3305 Dihydrate
Product Code: LX3305
INN or Proposed INN: None as of yet
Other descriptive name: LX3305
Lexicon Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
104Phase 2Hungary;Czech Republic;Bulgaria
6EUCTR2007-001420-12-CZ
(EUCTR)
16/01/200813/11/2007A Randomised, Double-Blind (with Open Comparator Etanercept Limb), Placebo-Controlled, Phase IIb, Multicentre Study to Evaluate the Efficacy of 4 Doses of AZD9056 Administered for 6 Months on the Signs and Symptoms of Rheumatoid Arthritis in Patients with Active Disease Receiving Background Methotrexate or SulphasalazineA Randomised, Double-Blind (with Open Comparator Etanercept Limb), Placebo-Controlled, Phase IIb, Multicentre Study to Evaluate the Efficacy of 4 Doses of AZD9056 Administered for 6 Months on the Signs and Symptoms of Rheumatoid Arthritis in Patients with Active Disease Receiving Background Methotrexate or Sulphasalazine Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: AZD9056 hydrochloride
Product Code: AZD9056
Other descriptive name: None
Product Name: AZD9056 hydrochloride
Product Code: AZD9056
Other descriptive name: None
Trade Name: Enbrel
Product Name: Enbrel
INN or Proposed INN: Etanercept
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
360Phase 2Czech Republic;France;Poland;Sweden
7ChiCTR-CCC-10001054
2008-01-012010-08-25Circulating Dickkopf-1 (DKK-1) is Correlated with Bone Erosion and Inflammation in Rheumatoid ArthritisCirculating Dickkopf-1 (DKK-1) is Correlated with Bone Erosion and Inflammation in Rheumatoid Arthritis ra1:none;2:Infliximab ;National Sciences Foundation of ChinaNULLCompleted2858Both1:39;2:39;China
8EUCTR2007-001420-12-PL
(EUCTR)
20/12/200717/10/2007A Randomised, Double-Blind (with Open Comparator Etanercept Limb), Placebo-Controlled, Phase IIb, Multicentre Study to Evaluate the Efficacy of 4 Doses of AZD9056 Administered for 6 Months on the Signs and Symptoms of Rheumatoid Arthritis in Patients with Active Disease Receiving Background Methotrexate or SulphasalazineA Randomised, Double-Blind (with Open Comparator Etanercept Limb), Placebo-Controlled, Phase IIb, Multicentre Study to Evaluate the Efficacy of 4 Doses of AZD9056 Administered for 6 Months on the Signs and Symptoms of Rheumatoid Arthritis in Patients with Active Disease Receiving Background Methotrexate or Sulphasalazine Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: AZD9056 hydrochloride
Product Code: AZD9056
Other descriptive name: None
Product Name: AZD9056 hydrochloride
Product Code: AZD9056
Other descriptive name: None
Trade Name: Enbrel
Product Name: Enbrel
INN or Proposed INN: Etanercept
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
360Phase 2Czech Republic;France;Poland;Sweden
9EUCTR2007-001420-12-FR
(EUCTR)
17/10/200723/07/2007A Randomised, Double-Blind (with Open Comparator Etanercept Limb), Placebo-Controlled, Phase IIb, Multicentre Study to Evaluate the Efficacy of 4 Doses of AZD9056 Administered for 6 Months on the Signs and Symptoms of Rheumatoid Arthritis in Patients with Active Disease Receiving Background Methotrexate or SulphasalazineA Randomised, Double-Blind (with Open Comparator Etanercept Limb), Placebo-Controlled, Phase IIb, Multicentre Study to Evaluate the Efficacy of 4 Doses of AZD9056 Administered for 6 Months on the Signs and Symptoms of Rheumatoid Arthritis in Patients with Active Disease Receiving Background Methotrexate or Sulphasalazine Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: AZD9056 hydrochloride
Product Code: AZD9056
Other descriptive name: None
Product Name: AZD9056 hydrochloride
Product Code: AZD9056
Other descriptive name: None
Trade Name: Enbrel
Product Name: Enbrel
INN or Proposed INN: Etanercept
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
360Phase 2France;Czech Republic;Slovakia;Poland;Belgium;Sweden
10EUCTR2007-001420-12-SK
(EUCTR)
15/10/200718/04/2008A Randomised, Double-Blind (with Open Comparator Etanercept Limb), Placebo-Controlled, Phase IIb, Multicentre Study to Evaluate the Efficacy of 4 Doses of AZD9056 Administered for 6 Months on the Signs and Symptoms of Rheumatoid Arthritis in Patients with Active Disease Receiving Background Methotrexate or SulphasalazineA Randomised, Double-Blind (with Open Comparator Etanercept Limb), Placebo-Controlled, Phase IIb, Multicentre Study to Evaluate the Efficacy of 4 Doses of AZD9056 Administered for 6 Months on the Signs and Symptoms of Rheumatoid Arthritis in Patients with Active Disease Receiving Background Methotrexate or Sulphasalazine Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: AZD9056 hydrochloride
Product Code: AZD9056
Other descriptive name: None
Product Name: AZD9056 hydrochloride
Product Code: AZD9056
Other descriptive name: None
Trade Name: Enbrel
Product Name: Enbrel
INN or Proposed INN: Etanercept
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
360Phase 2France;Czech Republic;Slovakia;Poland;Belgium;Sweden
11EUCTR2007-001420-12-SE
(EUCTR)
12/10/200720/07/2007A Randomised, Double-Blind (with Open Comparator Etanercept Limb), Placebo-Controlled, Phase IIb, Multicentre Study to Evaluate the Efficacy of 4 Doses of AZD9056 Administered for 6 Months on the Signs and Symptoms of Rheumatoid Arthritis in Patients with Active Disease Receiving Background Methotrexate or SulphasalazineA Randomised, Double-Blind (with Open Comparator Etanercept Limb), Placebo-Controlled, Phase IIb, Multicentre Study to Evaluate the Efficacy of 4 Doses of AZD9056 Administered for 6 Months on the Signs and Symptoms of Rheumatoid Arthritis in Patients with Active Disease Receiving Background Methotrexate or Sulphasalazine Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: AZD9056 hydrochloride
Product Code: AZD9056
Other descriptive name: None
Product Name: AZD9056 hydrochloride
Product Code: AZD9056
Other descriptive name: None
Trade Name: Enbrel
Product Name: Enbrel
INN or Proposed INN: Etanercept
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
360Phase 2Czech Republic;France;Poland;Sweden
12EUCTR2007-001420-12-BE
(EUCTR)
23/08/200709/07/2007A Randomised, Double-Blind (with Open Comparator Etanercept Limb), Placebo-Controlled, Phase IIb, Multicentre Study to Evaluate the Efficacy of 4 Doses of AZD9056 Administered for 6 Months on the Signs and Symptoms of Rheumatoid Arthritis in Patients with Active Disease Receiving Background Methotrexate or SulphasalazineA Randomised, Double-Blind (with Open Comparator Etanercept Limb), Placebo-Controlled, Phase IIb, Multicentre Study to Evaluate the Efficacy of 4 Doses of AZD9056 Administered for 6 Months on the Signs and Symptoms of Rheumatoid Arthritis in Patients with Active Disease Receiving Background Methotrexate or Sulphasalazine Rheumatoid Arthritis
MedDRA version: 9.1;Level: LLT;Classification code 10039073;Term: Rheumatoid arthritis
Product Name: AZD9056 hydrochloride
Product Code: AZD9056
Other descriptive name: None
Product Name: AZD9056 hydrochloride
Product Code: AZD9056
Other descriptive name: None
Trade Name: Enbrel
Product Name: Enbrel
INN or Proposed INN: Etanercept
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
360Phase 2France;Czech Republic;Poland;Belgium;Sweden
13EUCTR2005-000674-43-GB
(EUCTR)
06/04/200503/10/2005 AN OPEN LABEL STUDY OF THE EFFECT OF TREATMENT WITH RITUXIMAB ON RESISTANT RHEUMATOID ARTHRITIS: Clinical, radiological, synovial and immunological outcomes - Rituximab in Rheumatoid Arthritis AN OPEN LABEL STUDY OF THE EFFECT OF TREATMENT WITH RITUXIMAB ON RESISTANT RHEUMATOID ARTHRITIS: Clinical, radiological, synovial and immunological outcomes - Rituximab in Rheumatoid Arthritis Rheumatoid ArthritisTrade Name: Mabthera
Product Name: Mabthera
Product Code: N/A
INN or Proposed INN: n/a
Other descriptive name: none
University of LeedsNULLNot Recruiting Female: yes
Male: yes
15 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited Kingdom
14NCT00000435
(ClinicalTrials.gov)
September 199921/1/2000dnaJ Peptide for Relieving Rheumatoid ArthritisA Clinical Trial of Shared Epitope Peptides in Rheumatoid Arthritis (RA)Rheumatoid ArthritisDrug: dnaJ peptide;Drug: None-placeboNational Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NULLCompleted18 Years85 YearsBoth160Phase 2United States

51. 全身性強皮症


臨床試験数 : 523 薬物数 : 608 - (DrugBank : 156) / 標的遺伝子数 : 114 - 標的パスウェイ数 : 215
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2020-005116-21-PL
(EUCTR)
27/09/202125/06/2021FT011 for SclerodermaA phase II, randomised, double blind, placebo-controlled study of the pharmacokinetics, pharmacodynamic effects, and safety, oforal FT011 in participants with diffuse systemic sclerosis - FT011 for scleroderma diffuse systemic sclerosis
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: FT011 100 mg
Product Code: FT011
INN or Proposed INN: None yet
Other descriptive name: 2-(((2E)-3-(3-methoxy-4-(2-propyn-1-yloxy)phenyl)-1-oxo-2-propen-1-yl)amino)benzoic acid
Product Name: FT011 200 mg
Product Code: FT011
INN or Proposed INN: None yet
Other descriptive name: 2-(((2E)-3-(3-methoxy-4-(2-propyn-1-yloxy)phenyl)-1-oxo-2-propen-1-yl)amino)benzoic acid
Certa Therapeutics Pty LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 2Spain;Poland;Ukraine;Australia;Russian Federation;Netherlands
2EUCTR2020-005116-21-ES
(EUCTR)
22/07/202122/07/2021FT011 for SclerodermaA phase II, randomised, double blind, placebo-controlled study of the pharmacokinetics, pharmacodynamic effects, and safety, oforal FT011 in participants with diffuse systemic sclerosis - FT011 for scleroderma diffuse systemic sclerosis
MedDRA version: 21.0;Level: LLT;Classification code 10012977;Term: Diffuse systemic sclerosis;System Organ Class: 100000004859;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: FT011 100 mg
Product Code: FT011
INN or Proposed INN: None yet
Other descriptive name: 2-(((2E)-3-(3-methoxy-4-(2-propyn-1-yloxy)phenyl)-1-oxo-2-propen-1-yl)amino)benzoic acid
Product Name: FT011 200 mg
Product Code: FT011
INN or Proposed INN: None yet
Other descriptive name: 2-(((2E)-3-(3-methoxy-4-(2-propyn-1-yloxy)phenyl)-1-oxo-2-propen-1-yl)amino)benzoic acid
Certa Therapeutics Pty LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
30Phase 2Poland;Spain;Ukraine;Australia;Russian Federation;Netherlands

65. 原発性免疫不全症候群


臨床試験数 : 482 薬物数 : 653 - (DrugBank : 119) / 標的遺伝子数 : 92 - 標的パスウェイ数 : 212
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2018-004489-32-AT
(EUCTR)
02/10/201907/03/2019A study to a) evaluate the tolerability and blood levels of KVD900 when given as a single dose to patients and b) to assess whether KVD900 is effective in treating attacks of swelling in patients with the genetic disease, Hereditary Angioedema.A randomized, double-blind, placebo-controlled, phase II, cross-over clinical trial evaluating the efficacy and safety of KVD900, an oral plasma kallikrein inhibitor, in the on-demand treatment of angioedema attacks in adult subjects with hereditary angioedema type I or II Hereditary Angioedema Type I or II;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]Product Name: KVD900 100 mg Film Coated Tablet
INN or Proposed INN: None
Other descriptive name: KVD900
KalVista Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2United States;Hungary;Macedonia, the former Yugoslav Republic of;Poland;Austria;Netherlands;Germany;Italy;United Kingdom
2EUCTR2018-004489-32-PL
(EUCTR)
29/08/201929/05/2019A study to a) evaluate the tolerability and blood levels of KVD900 when given as a single dose to patients and b) to assess whether KVD900 is effective in treating attacks of swelling in patients with the genetic disease, Hereditary Angioedema.A randomized, double-blind, placebo-controlled, phase II, cross-over clinical trial evaluating the efficacy and safety of KVD900, an oral plasma kallikrein inhibitor, in the on-demand treatment of angioedema attacks in adult subjects with hereditary angioedema type I or II Hereditary Angioedema Type I or II
MedDRA version: 23.1;Level: PT;Classification code 10019860;Term: Hereditary angioedema;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: KVD900 100 mg Film Coated Tablet
INN or Proposed INN: None
Other descriptive name: KVD900
KalVista Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2United States;Hungary;Macedonia, the former Yugoslav Republic of;Poland;Austria;Netherlands;Germany;Italy;United Kingdom
3EUCTR2018-004489-32-DE
(EUCTR)
24/06/201912/02/2019A study to a) evaluate the tolerability and blood levels of KVD900 when given as a single dose to patients and b) to assess whether KVD900 is effective in treating attacks of swelling in patients with the genetic disease, Hereditary Angioedema.A randomized, double-blind, placebo-controlled, phase II, cross-over clinical trial evaluating the efficacy and safety of KVD900, an oral plasma kallikrein inhibitor, in the on-demand treatment of angioedema attacks in adult subjects with hereditary angioedema type I or II Hereditary Angioedema Type I or II;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]Product Name: KVD900 100 mg Film Coated Tablet
INN or Proposed INN: None
Other descriptive name: KVD900
KalVista Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2United States;Hungary;Poland;Austria;North Macedonia;Netherlands;Germany;Italy;United Kingdom
4EUCTR2018-004489-32-NL
(EUCTR)
19/06/201925/03/2019A study to a) evaluate the tolerability and blood levels of KVD900 when given as a single dose to patients and b) to assess whether KVD900 is effective in treating attacks of swelling in patients with the genetic disease, Hereditary Angioedema.A randomized, double-blind, placebo-controlled, phase II, cross-over clinical trial evaluating the efficacy and safety of KVD900, an oral plasma kallikrein inhibitor, in the on-demand treatment of angioedema attacks in adult subjects with hereditary angioedema type I or II Hereditary Angioedema Type I or II;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]Product Name: KVD900 100 mg Film Coated Tablet
INN or Proposed INN: None
Other descriptive name: KVD900
KalVista Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2United States;Hungary;Poland;Austria;North Macedonia;Germany;Netherlands;Italy;United Kingdom
5EUCTR2018-004489-32-HU
(EUCTR)
21/05/201925/03/2019A study to a) evaluate the tolerability and blood levels of KVD900 when given as a single dose to patients and b) to assess whether KVD900 is effective in treating attacks of swelling in patients with the genetic disease, Hereditary Angioedema.A randomized, double-blind, placebo-controlled, phase II, cross-over clinical trial evaluating the efficacy and safety of KVD900, an oral plasma kallikrein inhibitor, in the on-demand treatment of angioedema attacks in adult subjects with hereditary angioedema type I or II Hereditary Angioedema Type I or II;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]Product Name: KVD900 100 mg Film Coated Tablet
INN or Proposed INN: None
Other descriptive name: KVD900
KalVista Pharmaceuticals Ltd.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2Hungary;Macedonia, the former Yugoslav Republic of;Poland;Austria;Netherlands;Germany;Italy;United Kingdom
6EUCTR2018-004489-32-GB
(EUCTR)
13/03/201927/12/2018A study to a) evaluate the tolerability and blood levels of KVD900 when given as a single dose to patients and b) to assess whether KVD900 is effective in treating attacks of swelling in patients with the genetic disease, Hereditary Angioedema.A randomized, double-blind, placebo-controlled, phase II, cross-over clinical trial evaluating the efficacy and safety of KVD900, an oral plasma kallikrein inhibitor, in the on-demand treatment of angioedema attacks in adult subjects with hereditary angioedema type I or II Hereditary Angioedema Type I or II;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]Product Name: KVD900 100 mg Film Coated Tablet
INN or Proposed INN: None
Other descriptive name: KVD900
KalVista Pharmaceuticals LtdNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
60 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Hungary;Macedonia, the former Yugoslav Republic of;Austria;Netherlands;Germany;United Kingdom
7JPRN-jRCTs031180398
30/05/201820/03/2019A phase II study of RIC-SCT for CGDReduced intensity conditioning allogeneic stem cell transplantation with dose-adjusted busulfan and anti-thymocyte globulin for chronic granulomatous disease: a multicenter phase II trial - CGD-RIST2 Chronic granulomatous disease
Primary immunodeficiency;D006105
Conditioning regimen with targeted-busulfan and fludarabin
Total body irradiation (3Gy) at day -1
Stem cell transplantation at day 0
Sakaguchi HirotoshiNULLRecruitingNot applicable< 25age oldBoth22Phase 2None (Japan only);Japan

78. 下垂体前葉機能低下症


臨床試験数 : 494 薬物数 : 385 - (DrugBank : 49) / 標的遺伝子数 : 44 - 標的パスウェイ数 : 100
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2015-001939-21-LV
(EUCTR)
15/08/201631/05/2016A clinical study in paediatric patients with growth hormone deficiency to assess safety, tolerability, and efficacy of GX-H9A phase 2, randomized, open-label, active controlled, dose finding study of the long-acting hybrid Fc fused recombinant human growth hormone (GX-H9) in paediatric patients with growth hormone deficiency Growth Hormone Deficiency (GHD) in pre-pubertal children
MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: GX-H9
INN or Proposed INN: none
Other descriptive name: hGH-hyFc, recombinant human growth hormone
Trade Name: Genotropin®
Product Name: Genotropin®
INN or Proposed INN: SOMATROPIN
Other descriptive name: recombinant DNA-derived human growth hormone
Genexine, Inc.NULLNot RecruitingFemale: yes
Male: yes
48Phase 2Serbia;Belarus;Estonia;Morocco;Slovakia;Greece;Spain;Ukraine;Lebanon;Lithuania;Turkey;Russian Federation;Egypt;Czech Republic;Hungary;Poland;Belgium;Romania;Latvia;Tunisia;Korea, Republic of
2EUCTR2015-001939-21-LT
(EUCTR)
04/05/201629/02/2016A clinical study in paediatric patients with growth hormone deficiency to assess safety, tolerability, and efficacy of GX-H9A phase 2, randomized, open-label, active controlled, dose finding study of the long-acting hybrid Fc fused recombinant human growth hormone (GX-H9) in paediatric patients with growth hormone deficiency Growth Hormone Deficiency (GHD) in pre-pubertal children
MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: GX-H9
INN or Proposed INN: none
Other descriptive name: hGH-hyFc, recombinant human growth hormone
Trade Name: Genotropin®
Product Name: Genotropin®
INN or Proposed INN: SOMATROPIN
Other descriptive name: recombinant DNA-derived human growth hormone
Genexine, Inc.NULLNot RecruitingFemale: yes
Male: yes
48Phase 2Serbia;Belarus;Estonia;Morocco;Slovakia;Greece;Spain;Ukraine;Lebanon;Lithuania;Turkey;Russian Federation;Egypt;Czech Republic;Hungary;Poland;Belgium;Romania;Latvia;Tunisia;Korea, Republic of
3EUCTR2015-001939-21-PL
(EUCTR)
19/04/201618/01/2016A clinical study in paediatric patients with growth hormone deficiency to assess safety, tolerability, and efficacy of GX-H9A phase 2, randomized, open-label, active controlled, dose finding study of the long-acting hybrid Fc fused recombinant human growth hormone (GX-H9) in paediatric patients with growth hormone deficiency Growth Hormone Deficiency (GHD) in pre-pubertal children
MedDRA version: 20.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: GX-H9
INN or Proposed INN: none
Other descriptive name: hGH-hyFc, recombinant human growth hormone
Trade Name: Genotropin®
Product Name: Genotropin®
INN or Proposed INN: SOMATROPIN
Other descriptive name: recombinant DNA-derived human growth hormone
Genexine, Inc.NULLNot RecruitingFemale: yes
Male: yes
56Phase 2Belarus;Serbia;Estonia;Slovakia;Greece;Ukraine;Lebanon;Lithuania;Turkey;Russian Federation;Hungary;Czech Republic;Poland;Latvia;Korea, Republic of
4EUCTR2015-001939-21-EE
(EUCTR)
30/03/201616/02/2016A clinical study in paediatric patients with growth hormone deficiency to assess safety, tolerability, and efficacy of GX-H9A phase 2, randomized, open-label, active controlled, dose finding study of the long-acting hybrid Fc fused recombinant human growth hormone (GX-H9) in paediatric patients with growth hormone deficiency Growth Hormone Deficiency (GHD) in pre-pubertal children
MedDRA version: 19.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: GX-H9
INN or Proposed INN: none
Other descriptive name: hGH-hyFc, recombinant human growth hormone
Trade Name: Genotropin®
Product Name: Genotropin®
INN or Proposed INN: SOMATROPIN
Other descriptive name: recombinant DNA-derived human growth hormone
Genexine, Inc.NULLNot RecruitingFemale: yes
Male: yes
48Phase 2Serbia;Belarus;Estonia;Morocco;Slovakia;Greece;Spain;Ukraine;Lebanon;Lithuania;Turkey;Russian Federation;Egypt;Czech Republic;Hungary;Poland;Belgium;Romania;Latvia;Tunisia;Korea, Republic of
5EUCTR2015-001939-21-GR
(EUCTR)
12/11/201513/10/2015A clinical study in paediatric patients with growth hormone deficiency to assess safety, tolerability, and efficacy of GX-H9A phase 2, randomized, open-label, active controlled, dose finding study of the long-acting hybrid Fc fused recombinant human growth hormone (GX-H9) in paediatric patients with growth hormone deficiency Growth Hormone Deficiency (GHD) in pre-pubertal children
MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: GX-H9
INN or Proposed INN: none
Other descriptive name: hGH-hyFc, recombinant human growth hormone
Trade Name: Genotropin®
Product Name: Genotropin®
INN or Proposed INN: SOMATROPIN
Other descriptive name: recombinant DNA-derived human growth hormone
Genexine, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
48Phase 2Serbia;Belarus;Slovakia;Morocco;Greece;Spain;Ukraine;Lebanon;Turkey;Russian Federation;Egypt;Czech Republic;Hungary;Poland;Belgium;Romania;Tunisia
6EUCTR2015-001939-21-SK
(EUCTR)
22/10/201527/07/2015A clinical study in paediatric patients with growth hormone deficiency to assess safety, tolerability, and efficacy of GX-H9A phase 2, randomized, open-label, active controlled, dose finding study of the long-acting hybrid Fc fused recombinant human growth hormone (GX-H9) in paediatric patients with growth hormone deficiency Growth Hormone Deficiency (GHD) in pre-pubertal children
MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: GX-H9
INN or Proposed INN: none
Other descriptive name: hGH-hyFc, recombinant human growth hormone
Trade Name: Genotropin®
Product Name: Genotropin®
INN or Proposed INN: SOMATROPIN
Other descriptive name: recombinant DNA-derived human growth hormone
Genexine, Inc.NULLNot RecruitingFemale: yes
Male: yes
48Phase 2Serbia;Belarus;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Lithuania;Turkey;Russian Federation;Egypt;Czech Republic;Hungary;Poland;Romania;Latvia;Tunisia
7EUCTR2015-001939-21-CZ
(EUCTR)
14/10/201510/07/2015A clinical study in paediatric patients with growth hormone deficiency to assess safety, tolerability, and efficacy of GX-H9A phase 2, randomized, open-label, active controlled, dose finding study of the long-acting hybrid Fc fused recombinant human growth hormone (GX-H9) in paediatric patients with growth hormone deficiency Growth Hormone Deficiency (GHD) in pre-pubertal children
MedDRA version: 18.0;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: GX-H9
INN or Proposed INN: none
Other descriptive name: hGH-hyFc, recombinant human growth hormone
Trade Name: Genotropin®
Product Name: Genotropin®
INN or Proposed INN: SOMATROPIN
Other descriptive name: recombinant DNA-derived human growth hormone
Genexine, Inc.NULLNot RecruitingFemale: yes
Male: yes
48Phase 2Serbia;Belarus;Estonia;Slovakia;Greece;Spain;Ukraine;Lebanon;Lithuania;Turkey;Russian Federation;Egypt;Czech Republic;Hungary;Poland;Romania;Latvia;Tunisia
8EUCTR2015-001939-21-HU
(EUCTR)
16/07/201522/05/2015A clinical study in paediatric patients with growth hormone deficiency to assess safety, tolerability, and efficacy of GX-H9A phase 2, randomized, open-label, active controlled, dose finding study of the long-acting hybrid Fc fused recombinant human growth hormone (GX-H9) in paediatric patients with growth hormone deficiency Growth Hormone Deficiency (GHD) in pre-pubertal children
MedDRA version: 19.1;Level: PT;Classification code 10056438;Term: Growth hormone deficiency;System Organ Class: 10014698 - Endocrine disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Product Name: GX-H9
INN or Proposed INN: none
Other descriptive name: hGH-hyFc, recombinant human growth hormone
Trade Name: Genotropin®
Product Name: Genotropin®
INN or Proposed INN: SOMATROPIN
Other descriptive name: recombinant DNA-derived human growth hormone
Genexine, Inc.NULLNot RecruitingFemale: yes
Male: yes
48Phase 2Serbia;Belarus;Estonia;Slovakia;Greece;Ukraine;Lebanon;Turkey;Lithuania;Russian Federation;Hungary;Czech Republic;Poland;Romania;Latvia;Tunisia;Korea, Republic of
9NCT02360046
(ClinicalTrials.gov)
January 201516/1/2015The Influence of Different Hydrocortisone Replacement Doses on the Partitioning and Flexibility of Ectopic Lipids in Patients With Corticotropic HypopituitarismThe Influence of Different Hydrocortisone Replacement Doses on the Partitioning and Flexibility of Ectopic Lipids (Intrahepatocellular IHCL and Intramyocellular IMCL) in Patients With Corticotropic Hypopituitarism, a Randomised Placebo-controlled Double-blind TrialHypopituitarism;Hydrocortisone;Lipids;Fatty Acids, Nonesterified;Insulin SensitivityDrug: Hydrocortisone;Drug: PlaceboUniversity Hospital Inselspital, BerneNULLTerminated18 YearsN/AAll30N/ASwitzerland

84. サルコイドーシス


臨床試験数 : 149 薬物数 : 227 - (DrugBank : 81) / 標的遺伝子数 : 82 - 標的パスウェイ数 : 167
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2016-000342-60-GB
(EUCTR)
21/06/201606/02/2019Fatigue and Sarcoidosis: Treatment with MethylphenidateFatigue in Sarcoidosis - A feasibility study investigating the treatment of fatigue in stable sarcoidosis patients using methylphenidate - Fatigue in Sarcoidosis: Treatment with Methylphenidate Sarcoidosis-associated fatigue (Patients with stable sarcoidosis and chronic fatigue)
MedDRA version: 20.1;Level: PT;Classification code 10039486;Term: Sarcoidosis;System Organ Class: 10021428 - Immune system disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Methylphenidate
Product Name: Methylphenidate 10mg tablets
Product Code: NA
INN or Proposed INN: Methylphenidate
Other descriptive name: None
Norfolk and Norwich University HospitalNULLNot Recruiting Female: yes
Male: yes
30 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited Kingdom

85. 特発性間質性肺炎


臨床試験数 : 598 薬物数 : 435 - (DrugBank : 116) / 標的遺伝子数 : 100 - 標的パスウェイ数 : 210
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-004998-34-GB
(EUCTR)
16/07/202004/02/2020A clinical study to investigate the safety and effects of a new drug called BLD-2660 in patients with Idiopathic Pulmonary FibrosisA Phase 2a, Double-Blind, Placebo-Controlled Study to Evaluate Pharmacodynamics, Pharmacokinetics, and Safety of BLD-2660 Administered Orally in Subjects with Idiopathic Pulmonary Fibrosis - B-2660-203 Idiopathic Pulmonary Fibrosis
MedDRA version: 21.1;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BLD-2660
Product Code: BLD-2660
INN or Proposed INN: None
Other descriptive name: BLD-2660
Blade Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
40Phase 2United Kingdom
2EUCTR2014-004058-32-GB
(EUCTR)
19/12/201412/06/2015Treating pulmonary fibrosis with co-trimoxazoleThe Efficacy and Mechanism Evaluation of Treating Idiopathic Pulmonary Fibrosis with the Addition of Co-trimoxazole (EME-TIPAC) - Treating pulmonary fibrosis with co-trimoxazole Idiopathic Pulmonary Fibrosis
MedDRA version: 18.0;Level: PT;Classification code 10021240;Term: Idiopathic pulmonary fibrosis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cotrimoxazole
Product Name: Cotrimoxazole
Product Code: NA
INN or Proposed INN: trimethoprim
Other descriptive name: none
INN or Proposed INN: sulphamethoxazole
Other descriptive name: none
Norfolk and Norwich University Hospital NHS Foundation TrustNULLNot RecruitingFemale: yes
Male: yes
330Phase 3United Kingdom

96. クローン病


臨床試験数 : 2,400 薬物数 : 1,391 - (DrugBank : 267) / 標的遺伝子数 : 170 - 標的パスウェイ数 : 215
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2019-000886-19-FR
(EUCTR)
20/01/202026/07/2019A study to evaluate the effects of TAK-018 on recurrence of Crohn’s Disease patients after bowel resectionA Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2a Study to Evaluate the Safety, Tolerability, and Early Proof of Concept of TAK-018 for the Prevention of Postoperative Crohn’s Disease Recurrence Crohn’s Disease
MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Code: TAK-018
INN or Proposed INN: None at this time
Other descriptive name: EB8018
Product Code: TAK-018
INN or Proposed INN: None at this time
Other descriptive name: EB8018
Millennium Pharmaceuticals, Inc (a wholly owned subsidiaryNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
75 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;France;Germany;United Kingdom
2EUCTR2019-002093-32-SE
(EUCTR)
24/10/201928/06/2019A randomised, open, within-patient controlled trial to evaluate the diagnostic usefulness of Computed Tomography with the new contrast agent Lumentin® 44 as compared to Magnetic Resonance Imaging in patients with small bowel Crohn’s disease.Randomised, open, non-inferiority within patient-controlled trial evaluating the diagnostic usefulness of Lumentin® 44 when used as contrast agent in CT-enterography as compared to MRI- enterography in patients with small bowel Crohn’s disease. None.Lumentin 44 is a contrast agent. The diagnostic usefulness of CT with Lumentin 44 as contrast agent as compared to MRE will be investigated in this trial.Patients with confirmed small bowel Crohn's disease referred to MRE examination will be included in the trial. Neither their medical condition nor disease will be investigated.
MedDRA version: 22.1;Level: LLT;Classification code 10011603;Term: CT scan;System Organ Class: 100000004848;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
Product Name: Lumentin 44
Product Code: L 44
INN or Proposed INN: Egg Albumen Powder
Other descriptive name: EGG WHITE PROTEIN
Trade Name: Movprep
Lument ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
60Phase 2Sweden
3JPRN-jRCT1031190056
30/09/201917/07/2019E6011-CS1 studyResearch for medicinal predictive marker on Crohn's disease - E6011-CS1 study Crohn's disease
Crohn's disease;D003424
Study1:Evaluate the disease activity and collect the blood according to the schedule as below. Amount of blood collection should be about 15mL at screening test, after the beginning of the study, about 12.5mL per visit.

1.Adalimumab:At the beginning of the study, after that, 2, 4, 12, 24, 52 weeks after or at the termination
2.Infliximab:At the beginning of the study,after that, 2, 6, 14, 22, 54 weeks after or at the termination
3. Ustekinumab:At the beginning of the study,after that, 2, 8, 20, 32, 56weeks after or at the termination

Study2:None.
Mikami YoheiEA Pharma Co.,Ltd.(Utilize AMED's funds)Not Recruiting>= 16age oldNot applicableBoth32N/AJapan
4EUCTR2009-011621-14-AT
(EUCTR)
12/11/200919/10/2009A 52-week open label extension study to evaluate the safety and tolerability of AIN457 (anti IL-17 monoclonal antibody) in patients with moderate to severe Crohn’sdisease - A2202E1A 52-week open label extension study to evaluate the safety and tolerability of AIN457 (anti IL-17 monoclonal antibody) in patients with moderate to severe Crohn’sdisease - A2202E1 Moderate to severe Crohn's disease (CDAI = 220 and =450)
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: AIN457
Product Code: AIN457
INN or Proposed INN: Not available
Other descriptive name: None
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
72Germany;Austria
5EUCTR2008-004919-36-SE
(EUCTR)
11/03/200911/12/2008A Phase 2B, Multi-center, Randomized, Double- blind, Parallel Group, Placebo-controlled, Dose Ranging Study Comparing the Efficacy, Safety, and Pharmacokinetics of Intravenous Infusions of ABT - 874 vs. Placebo in Subjects with Moderately to Severely Active Crohn's DiseaseA Phase 2B, Multi-center, Randomized, Double- blind, Parallel Group, Placebo-controlled, Dose Ranging Study Comparing the Efficacy, Safety, and Pharmacokinetics of Intravenous Infusions of ABT - 874 vs. Placebo in Subjects with Moderately to Severely Active Crohn's Disease Crohn's disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: ABT-874
Product Code: ABT-874
INN or Proposed INN: None
Other descriptive name: J695, BSF 415977 (formerly LU415977), WAY-165772, A-796874.0
AbbottNULLNot RecruitingFemale: yes
Male: yes
225Phase 2Denmark;Austria;Sweden
6EUCTR2008-004919-36-DK
(EUCTR)
23/01/200918/12/2008A Phase 2B, Multi-center, Randomized, Double- blind, Parallel Group, Placebo-controlled, Dose Ranging Study Comparing the Efficacy, Safety, and Pharmacokinetics of Intravenous Infusions of ABT - 874 vs. Placebo in Subjects with Moderately to Severely Active Crohn's DiseaseA Phase 2B, Multi-center, Randomized, Double- blind, Parallel Group, Placebo-controlled, Dose Ranging Study Comparing the Efficacy, Safety, and Pharmacokinetics of Intravenous Infusions of ABT - 874 vs. Placebo in Subjects with Moderately to Severely Active Crohn's Disease Crohn's disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: ABT-874
Product Code: ABT-874
INN or Proposed INN: None
Other descriptive name: J695, BSF 415977 (formerly LU415977), WAY-165772, A-796874.0
AbbottNULLNot RecruitingFemale: yes
Male: yes
225Phase 2Denmark;Austria;Sweden
7EUCTR2008-004919-36-BE
(EUCTR)
20/01/200914/11/2008A Phase 2B, Multi-center, Randomized, Double- blind, Parallel Group, Placebo-controlled, Dose Ranging Study Comparing the Efficacy, Safety, and Pharmacokinetics of Intravenous Infusions of ABT - 874 vs. Placebo in Subjects with Moderately to Severely Active Crohn's DiseaseA Phase 2B, Multi-center, Randomized, Double- blind, Parallel Group, Placebo-controlled, Dose Ranging Study Comparing the Efficacy, Safety, and Pharmacokinetics of Intravenous Infusions of ABT - 874 vs. Placebo in Subjects with Moderately to Severely Active Crohn's Disease Crohn's disease
MedDRA version: 9.1;Level: LLT;Classification code 10011401;Term: Crohn's disease
Product Name: ABT-874
Product Code: ABT-874
INN or Proposed INN: None
Other descriptive name: J695, BSF 415977 (formerly LU415977), WAY-165772, A-796874.0
AbbottNULLNot RecruitingFemale: yes
Male: yes
225Phase 2Belgium;Denmark;Austria;Sweden

97. 潰瘍性大腸炎


臨床試験数 : 2,527 薬物数 : 1,465 - (DrugBank : 259) / 標的遺伝子数 : 144 - 標的パスウェイ数 : 202
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2020-003556-33-PL
(EUCTR)
19/04/202117/02/2021A Placebo-controlled Study of BBT-401-1S in Subjects with Moderate to Severe Ulcerative ColitisA Randomised, Double-blind, Placebo-controlled Study of Orally Administered BBT-401-1S in Subjects with Moderate to Severe Ulcerative Colitis, Incorporating a Response-Adaptive, Double-blind Extension Phase Moderate to severe ulcerative colitis.
MedDRA version: 20.0;Level: PT;Classification code 10009900;Term: Colitis ulcerative;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: BBT-401-1S
Product Code: BBT-401-1S
INN or Proposed INN: None
Other descriptive name: Sodium (S)-3-(4-hydroxyphenyl)-2-(2-((S)-1-((S)-1-palmitoylpyrrolidine-2-carbonyl)pyrrolidine-2-carboxamido)acetamido)propanoate
Bridge Biotherapeutics, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
36Phase 2United States;Poland;Ukraine;New Zealand;Korea, Republic of
2EUCTR2004-004184-29-DE
(EUCTR)
06/06/200501/03/2005A phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NAA phase III, randomised, multi-centre, double blind, parallel group, active comparator study to compare the efficacy and safety of SPD476 (mesalazine) 2.4g/day once daily (qd) versus Asacol® 1.6g/day twice daily (BID) in the maintenance of remission in patients with ulcerative colitis. - NA Ulcerative colitisProduct Name: None given
Product Code: SPD476
INN or Proposed INN: Mesalazine
Other descriptive name: 5-amino salicylic acid
Trade Name: Asacol Delayed Release Tablets
Product Name: Asacol
INN or Proposed INN: Mesalazine
Other descriptive name: 5-aminosalicylic acid
Shire Pharmaceutical Development LtdNULLNot RecruitingFemale: yes
Male: yes
410Phase 3Portugal;Hungary;Czech Republic;United Kingdom;Germany;Netherlands;Denmark;Spain;Sweden

140. ドラベ症候群


臨床試験数 : 104 薬物数 : 61 - (DrugBank : 14) / 標的遺伝子数 : 48 - 標的パスウェイ数 : 63
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2018-002484-25-PT
(EUCTR)
29/04/201919/11/2018A phase 2, multicenter, randomized, double-blind, controlled with placebo, to obtaine efficacy , safety and tolerability information for TAK-935 as an adjuntive therapy in pediatric patinets ((aged =2 and =17 years) with developmental and/or epileptic encephlopathies (Dravet syndrome and Lennox Gastaut)A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TAK-935 (OV935) AS AN ADJUNCTIVE THERAPY IN PEDIATRIC PATIENTS WITH DEVELOPMENTAL AND/OR EPILEPTIC ENCEPHALOPATHIES (ELEKTRA) Epileptic Encephalitis: Dravet and Lennox Gastuat syndrome (LGS);Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Code: TAK-935
INN or Proposed INN: None at this time
Product Code: TAK-935
INN or Proposed INN: None at this time
Takeda Development Center Americas, Inc.NULLNot RecruitingFemale: yes
Male: yes
126Phase 2United States;Portugal;Canada;Spain;Poland;Australia;Israel;China
2EUCTR2018-002484-25-PL
(EUCTR)
14/03/201911/12/2018A phase 2, multicenter, randomized, double-blind, controlled with placebo, to obtaine efficacy , safety and tolerability information for TAK-935 as an adjuntive therapy in pediatric patinets ((aged =2 and =17 years) with developmental and/or epileptic encephlopathies (Dravet syndrome and Lennox Gastaut)A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF TAK-935 (OV935) AS AN ADJUNCTIVE THERAPY IN PEDIATRIC PATIENTS WITH DEVELOPMENTAL AND/OR EPILEPTIC ENCEPHALOPATHIES (ELEKTRA) Epileptic Encephalitis: Dravet and Lennox Gastuat syndrome (LGS);Therapeutic area: Diseases [C] - Nervous System Diseases [C10]Product Code: TAK-935
INN or Proposed INN: None at this time
Product Code: TAK-935
INN or Proposed INN: None at this time
Takeda Development Center Americas, Inc.NULLNot RecruitingFemale: yes
Male: yes
126Phase 2United States;Portugal;Canada;Spain;Poland;Australia;Israel;China

160. 先天性魚鱗癬


臨床試験数 : 36 薬物数 : 72 - (DrugBank : 21) / 標的遺伝子数 : 18 - 標的パスウェイ数 : 111
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2011-001205-27-NL
(EUCTR)
04/08/201125/07/2011The effect of lipid lowering medication on lipid accumulation in patients with neutral lipid storage disease with muscle weakness.The effect of fibrate therapy in two patients with neutral lipid storage disease with myopathy (NLSDM). - Fibrate Trail Neutral lipid storage disease with myopathy
MedDRA version: 13.1;Level: PT;Classification code 10007636;Term: Cardiomyopathy;System Organ Class: 10007541 - Cardiac disorders
MedDRA version: 13.1;Level: HLGT;Classification code 10013317;Term: Lipid metabolism disorders;System Organ Class: 10027433 - Metabolism and nutrition disorders
MedDRA version: 13.1;Classification code 10028641;Term: Myopathy;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Trade Name: Bezalip Retard
Product Name: Bezalip Retard
Product Code: RVG 18388
INN or Proposed INN: BEZAFIBRATE
Other descriptive name: none
NULLAuthorised-recruitment may be ongoing or finishedFemale: no
Male: no
Netherlands

161. 家族性良性慢性天疱瘡


臨床試験数 : 5 薬物数 : 9 - (DrugBank : 4) / 標的遺伝子数 : 2 - 標的パスウェイ数 : 24
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2018-000373-80-FR
(EUCTR)
24/05/201813/03/2018A Phase 1/2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm Study of the Safety and Efficacy of LX3305, a Sphingosine-1-Phosphate Lyase Inhibitor, for Treatment of Darier’s Disease or Hailey-Hailey DiseaseA Phase 1/2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Arm Study of the Safety and Efficacy of LX3305, a Sphingosine-1-Phosphate Lyase Inhibitor, for Treatment of Darier’s Disease or Hailey-Hailey Disease - DERM-101 Darier’s Disease or Hailey-Hailey Disease
MedDRA version: 20.0;Level: LLT;Classification code 10011860;Term: Darier's disease;System Organ Class: 100000004850
MedDRA version: 20.1;Classification code 10019029;Term: Hailey-Hailey disease;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
Product Name: LX3305 250 mg capsule
Product Code: LX3305
INN or Proposed INN: None
Other descriptive name: (E)-1-(4-((1R,2S,3R)-1,2,3,4-tetrahydroxybutyl)-1H-imidazol-2-yl)ethanone oxime
Dermecular Therapeutics, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
40Phase 1;Phase 2France

171. ウィルソン病


臨床試験数 : 68 薬物数 : 79 - (DrugBank : 17) / 標的遺伝子数 : 3 - 標的パスウェイ数 : 28
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2014-001703-41-GB
(EUCTR)
11/05/201529/01/2015A clinical trial in adult Wilson Disease Patients to evaluate efficacy and safety of WTX101 following administration for 24 weeks with an Extension Phase of 12 MonthsA Phase 2, Multi-centre, Open-label, Study to Evaluate the Efficacy and Safety of WTX101 Administered for 24 Weeks in Newly Diagnosed Wilson Disease Patients Aged 18 and Older with an Extension Phase of 12 Months - Wilson Disease Patients to evaluate efficacy and safety of WTX101 Wilson Disease
MedDRA version: 18.1;Level: LLT;Classification code 10047988;Term: Wilson's disease;System Organ Class: 100000004850
Product Code: WTX101
INN or Proposed INN: none
Other descriptive name: bis-choline TETRATHIOMOLYBDATE
Wilson Therapeutics ABNULLNot Recruiting Female: yes
Male: yes
30 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Poland;Austria;Germany;United Kingdom
2EUCTR2014-001703-41-PL
(EUCTR)
22/12/201417/10/2014A clinical trial in adult Wilson Disease Patients to evaluate efficacy and safety of WTX101 following administration for 24 weeks and an extension phase of 36 months.A Phase 2, Multi-centre, Open-label, Study to Evaluate the Efficacy and Safety of WTX101 Administered for 24 Weeks in Newly Diagnosed Wilson Disease Patients Aged 18 and Older with an Extension Phase of 36 Months Wilson Disease
MedDRA version: 20.0;Level: LLT;Classification code 10047988;Term: Wilson's disease;System Organ Class: 100000004850;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Product Code: WTX101
INN or Proposed INN: none
Other descriptive name: bis-choline TETRATHIOMOLYBDATE
Wilson Therapeutics ABNULLNot RecruitingFemale: yes
Male: yes
30Phase 2United States;Poland;Austria;Germany;United Kingdom
3EUCTR2014-001703-41-AT
(EUCTR)
21/08/201424/06/2014A clinical trial in adult Wilson Disease Patients to evaluate efficacy and safety of WTX101 following administration for 24 weeks and an extension phase of 36 months. A Phase 2, Multi-centre, Open-label, Study to Evaluate the Efficacy and Safety of WTX101 Administered for 24 Weeks in Newly Diagnosed Wilson Disease Patients Aged 18 and Older with an Extension Phase of 36 Months Wilson Disease
MedDRA version: 20.0;Level: LLT;Classification code 10047988;Term: Wilson's disease;System Organ Class: 100000004850 ;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Product Code: WTX101
INN or Proposed INN: none
Other descriptive name: bis-choline TETRATHIOMOLYBDATE
Alexion Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
30 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Poland;Austria;Germany;United Kingdom
4EUCTR2014-001703-41-DE
(EUCTR)
18/08/201405/06/2014A clinical trial in adult Wilson Disease Patients to evaluate efficacy and safety of WTX101 following administration for 24 weeks and an extension phase of 36 months. A Phase 2, Multi-centre, Open-label, Study to Evaluate the Efficacy and Safety of WTX101 Administered for 24 Weeks in Newly Diagnosed Wilson Disease Patients Aged 18 and Older with an Extension Phase of 36 Months Wilson Disease
MedDRA version: 20.0;Level: LLT;Classification code 10047988;Term: Wilson's disease;System Organ Class: 100000004850 ;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]
Product Code: WTX101
INN or Proposed INN: none
Other descriptive name: bis-choline TETRATHIOMOLYBDATE
Alexion Pharmaceuticals, INC.NULLNot Recruiting Female: yes
Male: yes
30 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Poland;Austria;Germany;United Kingdom

231. α1−アンチトリプシン欠乏症


臨床試験数 : 89 薬物数 : 89 - (DrugBank : 16) / 標的遺伝子数 : 35 - 標的パスウェイ数 : 47
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2004-001688-23-GB
(EUCTR)
18/02/200819/10/2005A multicentre, double-blind, placebo-controlled randomized trial of the efficacy, safety and tolerability of 12 months of once daily treatment with 1 mg of RO3300074 in patients with symptomatic emphysema secondary to alpha-1-antitrypsin deficiencyA multicentre, double-blind, placebo-controlled randomized trial of the efficacy, safety and tolerability of 12 months of once daily treatment with 1 mg of RO3300074 in patients with symptomatic emphysema secondary to alpha-1-antitrypsin deficiency symptomatic emphysema secondary to alpha-1-antitrypsin deficiencyProduct Name: Not applicable
Product Code: RO3300074
INN or Proposed INN: None assigned
Other descriptive name: Retinoic Acid Receptor gamma Agonist
Product Name: Not applicable
Product Code: RO3300074
Other descriptive name: Retinoic Acid Receptor gamma Agonist
F. Hoffmann-La Roche LtdNULLNot Recruiting Female: yes
Male: yes
300 Human pharmacology (Phase 1): Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): Therapeutic use (Phase 4):Spain;Denmark;United Kingdom
2EUCTR2004-001688-23-DK
(EUCTR)
05/07/200630/05/2006A multicentre, double-blind, placebo-controlled randomized trial of the efficacy, safety and tolerability of 12 months of once daily treatment with 5 mg of RO3300074 in patients with symptomatic emphysema secondary to alpha-1-antitrypsin deficiencyA multicentre, double-blind, placebo-controlled randomized trial of the efficacy, safety and tolerability of 12 months of once daily treatment with 5 mg of RO3300074 in patients with symptomatic emphysema secondary to alpha-1-antitrypsin deficiency symptomatic emphysema secondary to alpha-1-antitrypsin deficiencyProduct Name: Not applicable
Product Code: RO3300074
INN or Proposed INN: None assigned
Other descriptive name: Retinoic Acid Receptor gamma Agonist
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
300United Kingdom;Denmark;Spain
3EUCTR2004-001688-23-ES
(EUCTR)
27/10/200421/10/2004A multicentre, double-blind, placebo-controlled randomized trial of the efficacy, safety and tolerability of 12 months of once daily treatment with 1 mg of RO3300074 in patients with symptomatic emphysema secondary to alpha-1-antitrypsin deficiencyA multicentre, double-blind, placebo-controlled randomized trial of the efficacy, safety and tolerability of 12 months of once daily treatment with 1 mg of RO3300074 in patients with symptomatic emphysema secondary to alpha-1-antitrypsin deficiency symptomatic emphysema secondary to alpha-1-antitrypsin deficiencyProduct Name: Not applicable
Product Code: RO3300074
INN or Proposed INN: None assigned
Other descriptive name: Retinoic Acid Receptor gamma Agonist
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
300United Kingdom;Denmark;Spain

271. 強直性脊椎炎


臨床試験数 : 563 薬物数 : 372 - (DrugBank : 72) / 標的遺伝子数 : 41 - 標的パスウェイ数 : 145
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1ChiCTR2100044377
2021-04-012021-03-17Study on the curative effect of spectrum therapy instrument in ankylosing spondylitisStudy on the curative effect of spectrum therapy instrument in ankylosing spondylitis Ankylosing spondylitisAS Spectrum Treatment Group:None;The First Affiliated Hospital of Suzhou UniversityNULLRecruiting1974BothAS Spectrum Treatment Group:40;China
2ChiCTR-ONRC-11001565
2009-06-012011-09-16research of genetic gene and immune state in Ankylosing Spondylitisresearch of genetic gene and immune state in ankylosing spondylitis Ankylosing SpondylitisAS patients:None;Healthy control:None;Department of Clinical Immunology, Xijing Hospital, Fourth Military Medical UniversityNULLCompleted1865BothAS patients:500;Healthy control:500;NULL

299. 嚢胞性線維症


臨床試験数 : 1,696 薬物数 : 1,644 - (DrugBank : 272) / 標的遺伝子数 : 96 - 標的パスウェイ数 : 170
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2017-003319-21-BE
(EUCTR)
08/11/201821/08/2018Study Assessing the Safety, Tolerability and Pharmacokinetics of PTI-808 in Healthy Adult Subjects and in Adults with Cystic FibrosisA Phase 1 / 2 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PTI-808 in Healthy Adult Subjects and in Adults with Cystic Fibrosis Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: N-(5-hydroxy-2,4-bis(trimethylsilyl)phenyl)-4-oxo-1,4-dihydroquinoline-3-carboxamide
Product Code: PTI-808
INN or Proposed INN: None
Other descriptive name: PTI-808
Product Name: Sodium (R)-8-methyl-2-(3-methylbenzofuran-2-yl)-5-(1-(tetrahydro-2H-pyran-4-yl)ethoxy)quinoline-4-ca
Product Code: PTI-801
INN or Proposed INN: None
Other descriptive name: PTI-801
Product Name: N-(trans-3-(5-((R)-1-hydroxyethyl)-1,3,4-oxadiazol-2-yl)cyclobutyl)-3-phenylisoxazole-5-carboxamide
Product Code: PTI-428
INN or Proposed INN: None
Other descriptive name: PTI-428
Proteostasis Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
240Phase 1;Phase 2United States;France;Canada;Belgium;Denmark;Germany;United Kingdom
2EUCTR2017-003319-21-DE
(EUCTR)
20/07/201809/04/2018Study Assessing the Safety, Tolerability and Pharmacokinetics of PTI-808 in Healthy Adult Subjects and in Adults with Cystic FibrosisA Phase 1 / 2 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PTI-808 in Healthy Adult Subjects and in Adults with Cystic Fibrosis Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Sodium (R)-8-methyl-2-(3-methylbenzofuran-2-yl)-5-(1-(tetrahydro-2H-pyran-4-yl)ethoxy)quinoline-4-ca
Product Code: PTI-801
INN or Proposed INN: None
Other descriptive name: PTI-801
Product Name: N-(5-hydroxy-2,4- bis(trimethylsilyl)phenyl)-4-oxo- 1,4-dihydroquinoline-3-carboxamide
Product Code: PTI-808
INN or Proposed INN: None
Other descriptive name: PTI-808
Product Name: N-(5-hydroxy-2,4- bis(trimethylsilyl)phenyl)-4-oxo- 1,4-dihydroquinoline-3-carboxamide
Product Code: PTI-808
INN or Proposed INN: None
Other descriptive name: PTI-808
Product Name: N-(trans-3-(5-((R)-1-hydroxyethyl)-1,3,4-oxadiazol-2-yl)cyclobutyl)-3-phenylisoxazole-5-carboxamide
Product Code: PTI-428
INN or Proposed INN: None
Other descriptive name: PTI-428
Proteostasis Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
240Phase 1;Phase 2United States;France;Canada;Belgium;Denmark;Germany;United Kingdom
3EUCTR2017-003319-21-GB
(EUCTR)
04/06/201803/07/2018Study Assessing the Safety, Tolerability and Pharmacokinetics of PTI-808 in Healthy Adult Subjects and in Adults with Cystic FibrosisA Phase 1 / 2 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PTI-808 in Healthy Adult Subjects and in Adults with Cystic Fibrosis Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: N-(5-hydroxy-2,4-bis(trimethylsilyl)phenyl)-4-oxo-1,4-dihydroquinoline-3-carboxamide
Product Code: PTI-808
INN or Proposed INN: None
Other descriptive name: PTI-808
Product Name: Sodium (R)-8-methyl-2-(3-methylbenzofuran-2-yl)-5-(1-(tetrahydro-2H-pyran-4-yl)ethoxy)quinoline-4-ca
Product Code: PTI-801
INN or Proposed INN: None
Other descriptive name: PTI-801
Product Name: N-(trans-3-(5-((R)-1-hydroxyethyl)-1,3,4-oxadiazol-2-yl)cyclobutyl)-3-phenylisoxazole-5-carboxamide
Product Code: PTI-428
INN or Proposed INN: None
Other descriptive name: PTI-428
Proteostasis Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
240Phase 1;Phase 2France;United States;Canada;Belgium;Denmark;Germany;United Kingdom
4EUCTR2009-014412-35-GB
(EUCTR)
23/02/201001/10/2009An International, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Administration of Two Strengths of Ciprofloxacin for Inhalation Compared with Placebo for Inhalation in the Management of Pseudomonas aeruginosa in Patients with Non Cystic Fibrosis Bronchiectasis - N/AAn International, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Administration of Two Strengths of Ciprofloxacin for Inhalation Compared with Placebo for Inhalation in the Management of Pseudomonas aeruginosa in Patients with Non Cystic Fibrosis Bronchiectasis - N/A Non-cystic fibrosis bronchiectasis
MedDRA version: 12.0;Level: LLT;Classification code 10006446;Term: Bronchiectasis NOS
Product Name: Ciprofloxacin for Inhalation
Product Code: None assigned
INN or Proposed INN: CIPROFLOXACIN HYDROCHLORIDE
Aradigm CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
96Germany;United Kingdom
5EUCTR2009-014412-35-DE
(EUCTR)
27/01/201009/10/2009An International, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Administration of Two Strengths of Ciprofloxacin for Inhalation Compared with Placebo for Inhalation in the Management of Pseudomonas aeruginosa in Patients with Non Cystic Fibrosis Bronchiectasis - N/AAn International, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Administration of Two Strengths of Ciprofloxacin for Inhalation Compared with Placebo for Inhalation in the Management of Pseudomonas aeruginosa in Patients with Non Cystic Fibrosis Bronchiectasis - N/A Non-cystic fibrosis bronchiectasis
MedDRA version: 12.0;Level: LLT;Classification code 10006446;Term: Bronchiectasis NOS
Product Name: Ciprofloxacin for Inhalation
Product Code: None assigned
INN or Proposed INN: CIPROFLOXACIN HYDROCHLORIDE
Aradigm CorporationNULLNot RecruitingFemale: yes
Male: yes
96Phase 2Germany;United Kingdom
6EUCTR2008-001530-27-GB
(EUCTR)
11/03/200918/04/2008A Phase II, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy of 28 Day Oral Administration of AZD9668 in Patients with Cystic FibrosisA Phase II, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy of 28 Day Oral Administration of AZD9668 in Patients with Cystic Fibrosis Cystic Fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: AZD9668
Product Code: AZD9668
INN or Proposed INN: none
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
70Phase 2Germany;United Kingdom;Denmark;Sweden
7EUCTR2008-001530-27-DK
(EUCTR)
02/02/200920/11/2008A Phase II, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy of 28 Day Oral Administration of AZD9668 in Patients with Cystic FibrosisA Phase II, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy of 28 Day Oral Administration of AZD9668 in Patients with Cystic Fibrosis Cystic Fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: AZD9668
Product Code: AZD9668
INN or Proposed INN: none
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
70Phase 2Germany;United Kingdom;Denmark;Sweden
8EUCTR2008-001530-27-SE
(EUCTR)
06/08/200817/06/2008A Phase II, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy of 28 Day Oral Administration of AZD9668 in Patients with Cystic FibrosisA Phase II, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy of 28 Day Oral Administration of AZD9668 in Patients with Cystic Fibrosis Cystic Fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: AZD9668
Product Code: AZD9668
INN or Proposed INN: none
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
70Phase 2Germany;United Kingdom;Denmark;Sweden
9EUCTR2008-001530-27-DE
(EUCTR)
08/07/200826/05/2008A Phase II, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy of 28 Day Oral Administration of AZD9668 in Patients with Cystic FibrosisA Phase II, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy of 28 Day Oral Administration of AZD9668 in Patients with Cystic Fibrosis Cystic Fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: AZD9668
Product Code: AZD9668
INN or Proposed INN: none
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
65Phase 2United Kingdom;Germany;Denmark;Sweden
10EUCTR2007-006204-37-GB
(EUCTR)
03/07/200809/05/2008Glutamine supplementation for cystic fibrosis: a parallel group randomized controlled trial - Glutamine and CFGlutamine supplementation for cystic fibrosis: a parallel group randomized controlled trial - Glutamine and CF Cystic fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: Glutamine
Product Code: none
Other descriptive name: L-Glutamine
University of NottinghamNULLNot Recruiting Female: yes
Male: yes
44 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited Kingdom