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	EUCTR2019-001760-30-GB (EUCTR)	11/10/2019	27/06/2019	The aim of this study is to assess the safety, tolerability and efficacy of seladelpar in subjects with Primary Sclerosing Cholangitis (PSC)	A Phase 2, Randomized, Double-Blind, Placebo-Controlled Multiple Center Study to Evaluate the Safety, Tolerability, and Efficacy of Seladelpar Administered for 24 Weeks in Adult Patients with Primary Sclerosing Cholangitis (PSC)	Primary Sclerosing Cholangitis (PSC) is a chronic cholestatic liver disease that is characterized by diffuse inflammation and fibrosis of the bile ducts. The intra and/or extrahepatic bile ducts can be affected with ongoing ductal destruction leading to cholestasis, advanced fibrosis, and cirrhosis. Disease progression will eventually lead to liver failure with its consequent complications such as portal hypertension and increased risk of malignancy, including HCC and cholangiocarcinoma. MedDRA version: 20.1;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR	CymaBay Therapeutics	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 2	United States;Canada;Poland;Australia;Israel;Germany;United Kingdom
2	EUCTR2019-001760-30-PL (EUCTR)	18/09/2019	18/07/2019	The aim of this study is to assess the safety, tolerability and efficacy of seladelpar in subjects with Primary Sclerosing Cholangitis (PSC)	A Phase 2, Randomized, Double-Blind, Placebo-Controlled Multiple Center Study to Evaluate the Safety, Tolerability, and Efficacy of Seladelpar Administered for 24 Weeks in Adult Patients with Primary Sclerosing Cholangitis (PSC)	Primary Sclerosing Cholangitis (PSC) is a chronic cholestatic liver disease that is characterized by diffuse inflammation and fibrosis of the bile ducts. The intra and/or extrahepatic bile ducts can be affected with ongoing ductal destruction leading to cholestasis, advanced fibrosis, and cirrhosis. Disease progression will eventually lead to liver failure with its consequent complications such as portal hypertension and increased risk of malignancy, including HCC and cholangiocarcinoma. MedDRA version: 20.0;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]	Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR Product Name: Seladelpar Product Code: MBX-8025 INN or Proposed INN: SELADELPAR	CymaBay Therapeutics	NULL	Not Recruiting			Female: yes Male: yes	100	Phase 2	United States;Canada;Poland;Australia;Israel;Germany;United Kingdom
3	NCT04024813 (ClinicalTrials.gov)	August 15, 2019	20/6/2019	A Study to Evaluate the Safety, and Tolerability, and Efficacy of Seladelpar in Patients With PSC	A Phase 2, Randomized, Double Blind, Placebo Controlled, Multiple Center Study to Evaluate the Safety, Tolerability, and Efficacy of Seladelpar Administered for 24 Weeks in Adult Patients With Primary Sclerosing Cholangitis (PSC)	Primary Sclerosing Cholangitis	Drug: Seladelpar;Drug: Placebo to match Seladelpar	CymaBay Therapeutics, Inc.	NULL	Suspended	18 Years	N/A	All	1	Phase 2	United States;Canada;Poland

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

EUCTR2019-001760-30-GB
(EUCTR)

11/10/2019

27/06/2019

The aim of this study is to assess the safety, tolerability and efficacy of seladelpar in subjects with Primary Sclerosing Cholangitis (PSC)

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Multiple Center Study to Evaluate the Safety, Tolerability, and Efficacy of Seladelpar Administered for 24 Weeks in Adult Patients with Primary Sclerosing Cholangitis (PSC)

Primary Sclerosing Cholangitis (PSC) is a chronic cholestatic liver disease that is characterized by diffuse inflammation and fibrosis of the bile ducts. The intra and/or extrahepatic bile ducts can be affected with ongoing ductal destruction leading to cholestasis, advanced fibrosis, and cirrhosis. Disease progression will eventually lead to liver failure with its consequent complications such as portal hypertension and increased risk of malignancy, including HCC and cholangiocarcinoma.
MedDRA version: 20.1;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Product Name: Seladelpar
Product Code: MBX-8025
INN or Proposed INN: SELADELPAR
Product Name: Seladelpar
Product Code: MBX-8025
INN or Proposed INN: SELADELPAR
Product Name: Seladelpar
Product Code: MBX-8025
INN or Proposed INN: SELADELPAR

CymaBay Therapeutics

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 2

United States;Canada;Poland;Australia;Israel;Germany;United Kingdom

EUCTR2019-001760-30-PL
(EUCTR)

18/09/2019

18/07/2019

The aim of this study is to assess the safety, tolerability and efficacy of seladelpar in subjects with Primary Sclerosing Cholangitis (PSC)

Primary Sclerosing Cholangitis (PSC) is a chronic cholestatic liver disease that is characterized by diffuse inflammation and fibrosis of the bile ducts. The intra and/or extrahepatic bile ducts can be affected with ongoing ductal destruction leading to cholestasis, advanced fibrosis, and cirrhosis. Disease progression will eventually lead to liver failure with its consequent complications such as portal hypertension and increased risk of malignancy, including HCC and cholangiocarcinoma.
MedDRA version: 20.0;Level: LLT;Classification code 10036732;Term: Primary sclerosing cholangitis;System Organ Class: 100000004871;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

CymaBay Therapeutics

NULL

Not Recruiting

Female: yes
Male: yes

100

Phase 2

United States;Canada;Poland;Australia;Israel;Germany;United Kingdom

NCT04024813
(ClinicalTrials.gov)

August 15, 2019

20/6/2019

A Study to Evaluate the Safety, and Tolerability, and Efficacy of Seladelpar in Patients With PSC

A Phase 2, Randomized, Double Blind, Placebo Controlled, Multiple Center Study to Evaluate the Safety, Tolerability, and Efficacy of Seladelpar Administered for 24 Weeks in Adult Patients With Primary Sclerosing Cholangitis (PSC)

Primary Sclerosing Cholangitis

Drug: Seladelpar;Drug: Placebo to match Seladelpar

CymaBay Therapeutics, Inc.

NULL

Suspended

18 Years

N/A

All

Phase 2

United States;Canada;Poland