DDrare: Database of Drug Development for Rare Diseases

Searched query = "Chronic inflammatory demyelinating polyneuropathy", "Chronic inflammatory demyelinating poly (radiculo) neuropathy", "Multifocal motor neuropathy", "CIDP"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Drug = 0.9% sodium chloride; 10% intravenous immunoglobulin (IVIg); 10% liquid formulation of human immunoglobulin; : immunoglobulina umana normale 10% per somministrazione endovenosa; ARGX-113; Acthar; Albumin (Human) 25%, United States Pharmacopeia (USP); Anti-C5 antibody; Anti-Thymocyte Globulin; BIVV020; Biological : I10E (Human normal Immunoglobulin for intravenous administration 100mg/mL); Biological: Kiovig® (Human normal Immunoglobulin for intravenous administration 100mg/mL); CLORFENAMINA MALEATO; Carmustine; Chloride; Clorfenamina; Clorfenamina maleato; Cyclophosphamide; Cytarabine; Device: Vital EMS+; Dexamethasone; Eculizumab; Efgartigimod PH20 SC; Efgartigimod PH20 SC in stage B; Efgartigimod alfa; Etoposide; FAMPRIDINE; FINGOLIMOD HYDROCHLORIDE; FTY720; FTY720I; Fampridine; Fampyra; Fibrinogen; Fibrinogen concentrate; Fingolimod; Freeze-Dried Sulfonated Human Normal Immunoglobulin (GGS); GILENYA 0,5 mg cápsulas duras; Gammanorm; Gilenya; H.P. Acthar® Gel; HIDROCLORURO DE FINGOLIMOD; HUMAN IMMUNOGLOBULIN G; HUMAN NORMAL IMMUNOGLOBULIN; HUMAN NORMAL IMMUNOGLOBULIN (IV); Hematopoietic stem cell transplantation; Hizentra; Hizentra®; Human Immunoglobulin G; Human immunoglobulin G; Human normal 10% immunoglobulin for intravenous administration; Human normal 10% immunoglobulin for intravenous administrationn; Human normal immunoglobulin; Human normal immunoglobulin (SCIg); Human normal immunoglobulin G (IgG > 98% purity); Human normal immunoglobulin for intravenous administration; HyQvia; Hyqvia; I10; I10E; IGIV, 10%; IGVENA*FL 200ML 10G+SET; IMMUNOGLOBULIN G; IMMUNOGLOBULINA UMANA NORMALE per somministrazione endovenosa; IQYMUNE; IVIg; IgPro10; IgPro20; IgPro20 (high dose); IgPro20 (low dose); Immune Globulin 10% Intravenous Solution; Immune Globulin IV (Human), 10% Caprylate/Chromatography Purified; Immune Globulin Intravenous (human), 10%; Immune Globulin Subcutaneous (Human); Immune globulin; Immunoglobulin; Immunoglobulin G; Immunoglobulin perfusion; Immunoglobulina umana normale per somministrazione endovenosa; Immunoglobuline G; Immunoglobulins; Immunoglobulins, normal human, for extravascular adm.; Immunoglobulins, normal human, for intravascular adm.; Intravenous Immunoglobulin; Intravenous immunoglobulin; Intravenous immunoglobulin (IVIg); KIOVIG; KIOVIG 100 mg/ml solution for infusion; Kiovig; Lipoic acid; MABTHERA - 1 FIALA 500 MG 50 ML; MD1003; METILPREDNISOLONE SODIO SUCCINATO; MabThera; Melphalan; Methylprednisolon; Methylprednisolon (Solu-Medrol); Methylprednisolone; Methylprednisolone (Solu-Medrol); Metilprednisolone sodio succinato; NPB-01; NewGam; Other: Fresh Frozen Plasma; Other: Laboratory Biomarker Analysis; PANZYGA; PARACETAMOLO; Paracetamolo; Placebo; Prednisolone; Prednisone; Privigen; Privigen®; Procedure: Autologous Hematopoietic Stem Cell Transplantation; Procedure: Peripheral Blood Stem Cell Transplantation; Procedure: Syngeneic Bone Marrow Transplantation; RHuPH20; RITUXIMAB; ROZANOLIXIZUMAB; RVG 51680; RVG 56083; Rituximab; Rituximab (genetical recombination); Rozanolixizumab; SOLIRIS; SOLU MEDROL - 125 MG/2 ML POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE 1 FLACONE A DOPPIA CAMERA DA 125 MG/2 ML; Sodium Chloride 0.9%; Sodium chloride; Sodium chloride 0.9%; Soliris; Standard of Care; Subcutaneous immunoglobulin; Subcuvia; TACHIPIRINA - 1000 MG COMPRESSE 8 COMPRESSE; TRIMETON - 10 MG/1 ML SOLUZIONE INIETTABILE 5 FIALE 1 ML; UCB7665; Vivaglobin; [Clorfenamina maleato]; [Metilprednisolone sodio succinato]; [Paracetamolo]; [Rituximab]

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	NCT02638207 (ClinicalTrials.gov)	September 27, 2017	16/12/2015	Study to Evaluate Safety and Efficacy of Three Different Dosages of NewGam in Patients With Chronic Inflammatory Demyelinating Poly (Radiculo) Neuropathy	Prospective, Double-blind, Randomized, Multicenter Phase III Study Evaluating Efficacy and Safety of Three Different Dosages of NewGam in Patients With Chronic Inflammatory Demyelinating Poly(Radiculo)Neuropathy	Chronic Inflammatory Demyelinating Poly(Radiculo)Neuropathy	Drug: NewGam	Octapharma	NULL	Completed	18 Years	N/A	All	142	Phase 3	Bulgaria;Canada;Czechia;Germany;Hungary;Poland;Romania;Russian Federation;Ukraine;Australia;Denmark;Sweden
2	EUCTR2015-005443-14-BG (EUCTR)	07/09/2017	30/05/2017	Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory neuropathy.	Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory demyelinating poly(radiculo)neuropathy.	Chronic Inflammatory Demyelinating Poly(radiculo)-neuropathy (CIDP) MedDRA version: 20.0;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Trade Name: PANZYGA Product Name: NewGam INN or Proposed INN: Immunoglobulin G Other descriptive name: IMMUNOGLOBULIN G	Octapharma Pharmazeutika Produktionsges.m.b.H.	NULL	Not Recruiting			Female: yes Male: yes	140	Phase 3	Hungary;Czech Republic;Canada;Poland;Ukraine;Romania;Denmark;Australia;Russian Federation;Bulgaria;Germany;Sweden
3	EUCTR2015-005443-14-SE (EUCTR)	29/06/2017	07/04/2017	Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory neuropathy.	Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory demyelinating poly(radiculo)neuropathy.	Chronic Inflammatory Demyelinating Poly(radiculo)-neuropathy (CIDP) MedDRA version: 20.0;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Trade Name: PANZYGA Product Name: NewGam INN or Proposed INN: Immunoglobulin G Other descriptive name: IMMUNOGLOBULIN G	Octapharma Pharmazeutika Produktionsges.m.b.H.	NULL	Not Recruiting			Female: yes Male: yes	140	Phase 3	Hungary;Czech Republic;Canada;Poland;Ukraine;Romania;Denmark;Australia;Russian Federation;Bulgaria;Germany;Sweden
4	EUCTR2015-005443-14-CZ (EUCTR)	01/06/2017	12/04/2017	Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory neuropathy.	Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory demyelinating poly(radiculo)neuropathy.	Chronic Inflammatory Demyelinating Poly(radiculo)-neuropathy (CIDP) MedDRA version: 20.0;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Trade Name: PANZYGA Product Name: NewGam INN or Proposed INN: Immunoglobulin G Other descriptive name: IMMUNOGLOBULIN G	Octapharma Pharmazeutika Produktionsges.m.b.H.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	140	Phase 3	Hungary;Czech Republic;Canada;Poland;Ukraine;Romania;Denmark;Australia;Russian Federation;Bulgaria;Germany;Sweden
5	EUCTR2015-005443-14-DK (EUCTR)	01/06/2017	06/04/2017	Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory neuropathy.	Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory demyelinating poly(radiculo)neuropathy.	Chronic Inflammatory Demyelinating Poly(radiculo)-neuropathy (CIDP) MedDRA version: 19.1;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Trade Name: PANZYGA Product Name: NewGam INN or Proposed INN: Immunoglobulin G Other descriptive name: IMMUNOGLOBULIN G	Octapharma Pharmazeutika Produktionsges.m.b.H.	NULL	Not Recruiting			Female: yes Male: yes	140	Phase 3	Hungary;Czech Republic;Canada;Poland;Ukraine;Romania;Australia;Denmark;Russian Federation;Bulgaria;Germany;Sweden
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
6	EUCTR2015-005443-14-PL (EUCTR)	16/05/2017	13/05/2017	Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory neuropathy.	Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory demyelinating poly(radiculo)neuropathy.	Chronic Inflammatory Demyelinating Poly(radiculo)-neuropathy (CIDP) MedDRA version: 20.0;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Trade Name: PANZYGA Product Name: NewGam INN or Proposed INN: Immunoglobulin G Other descriptive name: IMMUNOGLOBULIN G	Octapharma Pharmazeutika Produktionsges.m.b.H.	NULL	Not Recruiting			Female: yes Male: yes	140	Phase 3	Hungary;Czech Republic;Canada;Poland;Ukraine;Romania;Denmark;Australia;Russian Federation;Bulgaria;Germany;Sweden
7	EUCTR2015-005443-14-HU (EUCTR)	12/05/2017	07/04/2017	Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory neuropathy.	Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory demyelinating poly(radiculo)neuropathy.	Chronic Inflammatory Demyelinating Poly(radiculo)-neuropathy (CIDP) MedDRA version: 19.1;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]	Trade Name: PANZYGA Product Name: NewGam INN or Proposed INN: Immunoglobulin G Other descriptive name: IMMUNOGLOBULIN G	Octapharma Pharmazeutika Produktionsges.m.b.H.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	140	Phase 3	Czech Republic;Hungary;Canada;Poland;Ukraine;Romania;Denmark;Australia;Russian Federation;Bulgaria;Germany;Sweden
8	EUCTR2015-005443-14-DE (EUCTR)	28/04/2017	05/04/2017	Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory neuropathy.	Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory demyelinating poly(radiculo)neuropathy.	Chronic Inflammatory Demyelinating Poly(radiculo)-neuropathy (CIDP) MedDRA version: 20.0;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12]		Octapharma Pharmazeutika Produktionsges.m.b.H.	NULL	Not Recruiting			Female: yes Male: yes	140	Phase 3	Hungary;Czech Republic;Canada;Poland;Ukraine;Romania;Denmark;Australia;Russian Federation;Bulgaria;Germany;Sweden
9	EUCTR2009-017805-13-CZ (EUCTR)	14/07/2011	22/04/2010	PROSPECTIVE, PARALLEL GROUP, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED, MULTICENTER, ADAPTIVE, TWO-STAGE PHASE II/III STUDY EVALUATING SAFETY AND EFFICACY OF THREE DIFFERENT DOSAGES OF NEWGAM IN PATIENTS WITH CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (POINT TRIAL)” - NGAM-03	PROSPECTIVE, PARALLEL GROUP, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED, MULTICENTER, ADAPTIVE, TWO-STAGE PHASE II/III STUDY EVALUATING SAFETY AND EFFICACY OF THREE DIFFERENT DOSAGES OF NEWGAM IN PATIENTS WITH CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (POINT TRIAL)” - NGAM-03	Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) MedDRA version: 14.0;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders	Product Name: NewGam Product Code: NewGam INN or Proposed INN: Immunoglobuline G Other descriptive name: NewGam	Octapharma AG	NULL	Not Recruiting			Female: yes Male: yes	172	Phase 2;Phase 3	Czech Republic;Bulgaria
10	EUCTR2009-017805-13-BG (EUCTR)	27/01/2011	13/12/2010	Study to evaluate efficacy of human immune globulin in patients with CIDP-chronic neuropathy.	PROSPECTIVE, PARALLEL GROUP, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMISED, MULTICENTRE, ADAPTIVE, TWO-STAGE PHASE II/III STUDY EVALUATING SAFETY AND EFFICACY OF THREE DIFFERENT DOSAGES OF NEWGAM IN PATIENTS WITH CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (POINT TRIAL)” - NGAM-03	Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) MedDRA version: 14.0;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]	Product Name: NewGam Product Code: NewGam INN or Proposed INN: Immunoglobuline G Other descriptive name: NewGam	Octapharma AG	NULL	Not Recruiting			Female: yes Male: yes	172	Phase 2;Phase 3	India;Serbia;Czech Republic;Mexico;Poland;Ukraine;Romania;Bulgaria
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
11	EUCTR2009-017805-13-RO (EUCTR)	08/09/2010	15/07/2010	PROSPECTIVE, PARALLEL GROUP, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED, MULTICENTER, ADAPTIVE, TWO-STAGE PHASE II/III STUDY EVALUATING SAFETY AND EFFICACY OF THREE DIFFERENT DOSAGES OF NEWGAM IN PATIENTS WITH CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (POINT TRIAL)” - NGAM-03	PROSPECTIVE, PARALLEL GROUP, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED, MULTICENTER, ADAPTIVE, TWO-STAGE PHASE II/III STUDY EVALUATING SAFETY AND EFFICACY OF THREE DIFFERENT DOSAGES OF NEWGAM IN PATIENTS WITH CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (POINT TRIAL)” - NGAM-03	Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) MedDRA version: 12.1;Level: LLT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy	Product Name: NewGam Product Code: NewGam INN or Proposed INN: Immunoglobuline G Other descriptive name: NewGam	Octapharma AG	NULL	Not Recruiting			Female: yes Male: yes	172	Phase 2;Phase 3	Czech Republic;Romania;Bulgaria

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

NCT02638207
(ClinicalTrials.gov)

September 27, 2017

16/12/2015

Study to Evaluate Safety and Efficacy of Three Different Dosages of NewGam in Patients With Chronic Inflammatory Demyelinating Poly (Radiculo) Neuropathy

Prospective, Double-blind, Randomized, Multicenter Phase III Study Evaluating Efficacy and Safety of Three Different Dosages of NewGam in Patients With Chronic Inflammatory Demyelinating Poly(Radiculo)Neuropathy

Chronic Inflammatory Demyelinating Poly(Radiculo)Neuropathy

Drug: NewGam

Octapharma

NULL

Completed

18 Years

N/A

All

142

Phase 3

Bulgaria;Canada;Czechia;Germany;Hungary;Poland;Romania;Russian Federation;Ukraine;Australia;Denmark;Sweden

EUCTR2015-005443-14-BG
(EUCTR)

07/09/2017

30/05/2017

Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory neuropathy.

Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory demyelinating poly(radiculo)neuropathy.

Chronic Inflammatory Demyelinating Poly(radiculo)-neuropathy (CIDP)
MedDRA version: 20.0;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]

Trade Name: PANZYGA
Product Name: NewGam
INN or Proposed INN: Immunoglobulin G
Other descriptive name: IMMUNOGLOBULIN G

Octapharma Pharmazeutika Produktionsges.m.b.H.

NULL

Not Recruiting

Female: yes
Male: yes

140

Phase 3

Hungary;Czech Republic;Canada;Poland;Ukraine;Romania;Denmark;Australia;Russian Federation;Bulgaria;Germany;Sweden

EUCTR2015-005443-14-SE
(EUCTR)

29/06/2017

07/04/2017

Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory neuropathy.

Trade Name: PANZYGA
Product Name: NewGam
INN or Proposed INN: Immunoglobulin G
Other descriptive name: IMMUNOGLOBULIN G

Octapharma Pharmazeutika Produktionsges.m.b.H.

NULL

Not Recruiting

Female: yes
Male: yes

140

Phase 3

Hungary;Czech Republic;Canada;Poland;Ukraine;Romania;Denmark;Australia;Russian Federation;Bulgaria;Germany;Sweden

EUCTR2015-005443-14-CZ
(EUCTR)

01/06/2017

12/04/2017

Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory neuropathy.

Trade Name: PANZYGA
Product Name: NewGam
INN or Proposed INN: Immunoglobulin G
Other descriptive name: IMMUNOGLOBULIN G

Octapharma Pharmazeutika Produktionsges.m.b.H.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

140

Phase 3

Hungary;Czech Republic;Canada;Poland;Ukraine;Romania;Denmark;Australia;Russian Federation;Bulgaria;Germany;Sweden

EUCTR2015-005443-14-DK
(EUCTR)

01/06/2017

06/04/2017

Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory neuropathy.

Chronic Inflammatory Demyelinating Poly(radiculo)-neuropathy (CIDP)
MedDRA version: 19.1;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]

Trade Name: PANZYGA
Product Name: NewGam
INN or Proposed INN: Immunoglobulin G
Other descriptive name: IMMUNOGLOBULIN G

Octapharma Pharmazeutika Produktionsges.m.b.H.

NULL

Not Recruiting

Female: yes
Male: yes

140

Phase 3

Hungary;Czech Republic;Canada;Poland;Ukraine;Romania;Australia;Denmark;Russian Federation;Bulgaria;Germany;Sweden

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2015-005443-14-PL
(EUCTR)

16/05/2017

13/05/2017

Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory neuropathy.

Trade Name: PANZYGA
Product Name: NewGam
INN or Proposed INN: Immunoglobulin G
Other descriptive name: IMMUNOGLOBULIN G

Octapharma Pharmazeutika Produktionsges.m.b.H.

NULL

Not Recruiting

Female: yes
Male: yes

140

Phase 3

Hungary;Czech Republic;Canada;Poland;Ukraine;Romania;Denmark;Australia;Russian Federation;Bulgaria;Germany;Sweden

EUCTR2015-005443-14-HU
(EUCTR)

12/05/2017

07/04/2017

Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory neuropathy.

Trade Name: PANZYGA
Product Name: NewGam
INN or Proposed INN: Immunoglobulin G
Other descriptive name: IMMUNOGLOBULIN G

Octapharma Pharmazeutika Produktionsges.m.b.H.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

140

Phase 3

Czech Republic;Hungary;Canada;Poland;Ukraine;Romania;Denmark;Australia;Russian Federation;Bulgaria;Germany;Sweden

EUCTR2015-005443-14-DE
(EUCTR)

28/04/2017

05/04/2017

Prospective, double-blind, randomized, multicenter phase III study evaluating efficacy and safety of three different dosages of NewGam in patients with chronic inflammatory neuropathy.

Chronic Inflammatory Demyelinating Poly(radiculo)-neuropathy (CIDP)
MedDRA version: 20.0;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Body processes [G] - Immune system processes [G12]

Octapharma Pharmazeutika Produktionsges.m.b.H.

NULL

Not Recruiting

Female: yes
Male: yes

140

Phase 3

Hungary;Czech Republic;Canada;Poland;Ukraine;Romania;Denmark;Australia;Russian Federation;Bulgaria;Germany;Sweden

EUCTR2009-017805-13-CZ
(EUCTR)

14/07/2011

22/04/2010

PROSPECTIVE, PARALLEL GROUP, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED, MULTICENTER, ADAPTIVE, TWO-STAGE PHASE II/III STUDY EVALUATING SAFETY AND EFFICACY OF THREE DIFFERENT DOSAGES OF NEWGAM IN PATIENTS WITH CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (POINT TRIAL)” - NGAM-03

Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
MedDRA version: 14.0;Level: PT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy;System Organ Class: 10029205 - Nervous system disorders

Product Name: NewGam
Product Code: NewGam
INN or Proposed INN: Immunoglobuline G
Other descriptive name: NewGam

Octapharma AG

NULL

Not Recruiting

Female: yes
Male: yes

172

Phase 2;Phase 3

Czech Republic;Bulgaria

EUCTR2009-017805-13-BG
(EUCTR)

27/01/2011

13/12/2010

Study to evaluate efficacy of human immune globulin in patients with CIDP-chronic neuropathy.

PROSPECTIVE, PARALLEL GROUP, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMISED, MULTICENTRE, ADAPTIVE, TWO-STAGE PHASE II/III STUDY EVALUATING SAFETY AND EFFICACY OF THREE DIFFERENT DOSAGES OF NEWGAM IN PATIENTS WITH CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (POINT TRIAL)” - NGAM-03

Product Name: NewGam
Product Code: NewGam
INN or Proposed INN: Immunoglobuline G
Other descriptive name: NewGam

Octapharma AG

NULL

Not Recruiting

Female: yes
Male: yes

172

Phase 2;Phase 3

India;Serbia;Czech Republic;Mexico;Poland;Ukraine;Romania;Bulgaria

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2009-017805-13-RO
(EUCTR)

08/09/2010

15/07/2010

Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
MedDRA version: 12.1;Level: LLT;Classification code 10057645;Term: Chronic inflammatory demyelinating polyradiculoneuropathy

Product Name: NewGam
Product Code: NewGam
INN or Proposed INN: Immunoglobuline G
Other descriptive name: NewGam

Octapharma AG

NULL

Not Recruiting

Female: yes
Male: yes

172

Phase 2;Phase 3

Czech Republic;Romania;Bulgaria