DDrare: Database of Drug Development for Rare Diseases

94. 原発性硬化性胆管炎
［臨床試験数：134，薬物数：105（DrugBank：37），標的遺伝子数：18，標的パスウェイ数：131］

Searched query = "Primary sclerosing cholangitis", "PSC"
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 = 11C-CSar; 3108006977; ACETYLCYSTEINE; ACIDO OBETICOLICO; ATRA; AZT; Acetylcysteine; All-trans retinoic acid; Azathioprine; BEFIZAL L.P. 400 mg, comprimé enrobé à libération prolongée; BEZAFIBRATE; BTT1023; BTT1023 IV Infusion 20 mg/mL, 5 mL Drug Product; Befizal; Bezafibrate; Bezafibrate (400mg) in addition to standard 15-20 mg/kg/jour UDCA therapy; Bezalip; Budesonide; C10AB02; CILO; CM-101; Calcium; Capecitabine; Cenicriviroc; Cenicriviroc 150 mg; Cilofexor; Cis-4-Hydroxy-L-Proline; Cladribine; Curcumin; DHA; DUR-928; Docosahexaenoic Acid (DHA); Docosahexaenoic acid; Engineered recombinant human FGF19; Entyvio; Erlotinib; Erlotinib (Tarceva); FLUIMUCIL*20CPR EFF 600MG; Fecal Microbiota Transplantation; Fenofibrate; Fluimucil; GS-6624; GS-9674; Gluten-free diet; HTD1801; Humanised IgG1 monoclonal antibody against human eotaxin-2; Hymecromone; ICG; INT-747, OCA; LUM001; MBX-8025; MLN0002; Metronidazole; Minocycline; Mitomycin; Mitomycin C; Mizoribine; NGM282; NorUDCA; NorUrsodeoxycholic Acid; NorUrsodeoxycholic acid; Normal saline; Norursodeoxycholic acid; OCA; OCA 1,5 mg; OCA 5 mg; Oral Vancomycin; Oral all-trans retinoic acid (ATRA); Orbcel-C; PLN-74809; Phenylbutyrate; Probiotics; Procedure: Liver transplantation; Procedure: Pre liver transplantation laparoscopic hand assisted staging; Proline; Radiation: 45 Gy external radiations; Radiation: Endoluminal bile duct Brachytherapy; Rec-h-FGF19; Retinoic acid; Rituximab; SELADELPAR; Seladelpar; Simtuzimab; Simtuzumab; Simvastatin; Simvastatin 40mg; Sulfasalazine; TBC; Thalidomide; UCMSC; UDCA; Ursodeoxycholic Acid; Ursodeoxycholic acid; Ursodeoxycholic acid (UDCA); Ursofalk; Ursolic acid; VEDOLIZUMAB; Vancomycin; Vedolizumab; Vedolizumab IV; Vidofludimus; Vidofludimus calcium; Volixibat; Xifaxan; [18F]FP-R01-MG-F2

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	NCT03678480 (ClinicalTrials.gov)	March 1, 2021	18/9/2018	A Study of HTD1801 in Adolescents With Primary Sclerosing Cholangitis (PSC)	A Phase 2, Randomized, Double-Blind Study of HTD1801 vs Ursodeoxycholic Acid (UDCA) in Adolescents With Primary Sclerosing Cholangitis (PSC)	Primary Sclerosing Cholangitis;Cholangitis;Cholangitis, Sclerosing;Bile Duct Diseases;Biliary Tract Diseases;Digestive System Diseases;Adolescent	Drug: HTD1801;Drug: Ursodeoxycholic Acid	HighTide Biopharma Pty Ltd	NULL	Not yet recruiting	12 Years	17 Years	All	104	Phase 2	NULL
2	NCT03333928 (ClinicalTrials.gov)	February 9, 2018	27/10/2017	A POC and Dose-Ranging Study of HTD1801 in PSC Patients	A Proof-of-Concept and Dose-Ranging Study Investigating the Efficacy and Safety of HTD1801 in Adult Subjects With Primary Sclerosing Cholangitis (PSC)	Primary Sclerosing Cholangitis (PSC)	Drug: HTD1801;Drug: Placebo	HighTide Biopharma Pty Ltd	NULL	Completed	18 Years	75 Years	All	59	Phase 2	United States;Canada
3	NCT03099603 (ClinicalTrials.gov)	March 24, 2017	14/3/2017	A Study of HTD1801 in Healthy Subjects	A First in Human, Randomized, Double-Blind Study to Assess Safety, Tolerability, and Pharmacokinetics of Single, Ascending Doses of HTD1801 in Healthy Subjects	Primary Sclerosing Cholangitis	Drug: HTD1801	HighTide Biopharma Pty Ltd	NULL	Completed	18 Years	50 Years	All	32	Phase 1	Australia

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

NCT03678480
(ClinicalTrials.gov)

March 1, 2021

18/9/2018

A Study of HTD1801 in Adolescents With Primary Sclerosing Cholangitis (PSC)

A Phase 2, Randomized, Double-Blind Study of HTD1801 vs Ursodeoxycholic Acid (UDCA) in Adolescents With Primary Sclerosing Cholangitis (PSC)

Primary Sclerosing Cholangitis;Cholangitis;Cholangitis, Sclerosing;Bile Duct Diseases;Biliary Tract Diseases;Digestive System Diseases;Adolescent

Drug: HTD1801;Drug: Ursodeoxycholic Acid

HighTide Biopharma Pty Ltd

NULL

Not yet recruiting

12 Years

17 Years

All

104

Phase 2

NULL

NCT03333928
(ClinicalTrials.gov)

February 9, 2018

27/10/2017

A POC and Dose-Ranging Study of HTD1801 in PSC Patients

A Proof-of-Concept and Dose-Ranging Study Investigating the Efficacy and Safety of HTD1801 in Adult Subjects With Primary Sclerosing Cholangitis (PSC)

Primary Sclerosing Cholangitis (PSC)

Drug: HTD1801;Drug: Placebo

HighTide Biopharma Pty Ltd

NULL

Completed

18 Years

75 Years

All

Phase 2

United States;Canada

NCT03099603
(ClinicalTrials.gov)

March 24, 2017

14/3/2017

A Study of HTD1801 in Healthy Subjects

A First in Human, Randomized, Double-Blind Study to Assess Safety, Tolerability, and Pharmacokinetics of Single, Ascending Doses of HTD1801 in Healthy Subjects

Primary Sclerosing Cholangitis

Drug: HTD1801

HighTide Biopharma Pty Ltd

NULL

Completed

18 Years

50 Years

All

Phase 1

Australia