DDrare: Database of Drug Development for Rare Diseases

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	EUCTR2015-003392-30-NL (EUCTR)	02/05/2016	17/12/2015	The testing of NGM282 for 12 weeks in patients with Primary Sclerosing Cholangitis (PSC)	A PHASE 2, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, PARALLEL GROUP, MULTIPLE CENTER STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFICACY OF NGM282 ADMINISTERED FOR 12 WEEKS IN PATIENTS WITH PRIMARY SCLEROSING CHOLANGITIS (PSC)	PRIMARY SCLEROSING CHOLANGITIS (PSC) MedDRA version: 19.0;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders MedDRA version: 19.0;Level: HLT;Classification code 10004607;Term: Bile duct infections and inflammations;Level: SOC;Classification code 10019805;Term: Hepatobiliary disorders;Level: PT;Classification code 10008609;Term: Cholangitis sclerosing;Level: HLGT;Classification code 10004606;Term: Bile duct disorders;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: NGM282 INN or Proposed INN: engineered recombinant human FGF19 Other descriptive name: rec-h-FGF19 Product Name: NGM282 INN or Proposed INN: engineered recombinant human FGF19 Other descriptive name: rec-h-FGF19	NGM Biopharmaceuticals, Inc.	NULL	Not Recruiting			Female: yes Male: yes	60	Phase 2	France;United States;Netherlands;United Kingdom

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EUCTR2015-003392-30-NL
(EUCTR)

02/05/2016

17/12/2015

The testing of NGM282 for 12 weeks in patients with Primary Sclerosing Cholangitis (PSC)

A PHASE 2, RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, PARALLEL GROUP, MULTIPLE CENTER STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFICACY OF NGM282 ADMINISTERED FOR 12 WEEKS IN PATIENTS WITH PRIMARY SCLEROSING CHOLANGITIS (PSC)

PRIMARY SCLEROSING CHOLANGITIS (PSC)
MedDRA version: 19.0;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 10019805 - Hepatobiliary disorders
MedDRA version: 19.0;Level: HLT;Classification code 10004607;Term: Bile duct infections and inflammations;Level: SOC;Classification code 10019805;Term: Hepatobiliary disorders;Level: PT;Classification code 10008609;Term: Cholangitis sclerosing;Level: HLGT;Classification code 10004606;Term: Bile duct disorders;System Organ Class: 10019805 - Hepatobiliary disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: NGM282
INN or Proposed INN: engineered recombinant human FGF19
Other descriptive name: rec-h-FGF19
Product Name: NGM282
INN or Proposed INN: engineered recombinant human FGF19
Other descriptive name: rec-h-FGF19

NGM Biopharmaceuticals, Inc.

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

France;United States;Netherlands;United Kingdom