A Study of TQA3526 in the Treatment of Primary Biliary Cirrhosis (PBC)
NCT04278820 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 130
Last updated 2020-02-20
Summary
TQA3526 is a modified bile acid and FXR agonist. FXR is a key regulator of bile acid synthesis and transport. Bile acids are used by the body to help with digestion. It is hypothesized that regular treatment with TQA3526 will improve liver function in persons with Primary Biliary Cirrhosis (PBC).
Conditions
- Primary Biliary Cirrhosis
Interventions
- DRUG
-
TQA3526
Tablet(s) administered orally once daily
- DRUG
-
Placebo to match TQA3526
Tablet(s) administered orally once daily
Sponsors & Collaborators
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- FACTORIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-03-20
- Primary Completion
- 2022-11-30
- Completion
- 2022-11-30
Countries
- China
Study Locations
More Related Trials
-
A Study in Reversing Hepatic Fibrosis or Cirrhosis Related to Hepatitis B Virus and Finding Biomarkers
NCT03568578 ·Status: UNKNOWN ·Phase: NA
-
IBAT Inhibitor A4250 for Cholestatic Pruritus
NCT02360852 ·Status: TERMINATED ·Phase: PHASE2
-
Obeticholic Acid Versus Placebo, in Combination with Ursodeoxycholic Acid in Patients with Primary Biliary Cirrhosis
NCT06715319 ·Status: COMPLETED ·Phase: PHASE3
-
A Multi-part, Double Blind Study to Assess Safety, Tolerability and Efficacy of Tropifexor (LJN452) in PBC Patients
NCT02516605 ·Status: COMPLETED ·Phase: PHASE2
-
Pharmacokinetic Study Of Tigecycline In Adult Subjects With Primary Biliary Cirrhosis
NCT00406237 ·Status: COMPLETED ·Phase: PHASE1
-
Safety, Tolerability of OP-724 in Patients With Primary Biliary Cholangitis (Phase I)
NCT04047160 ·Status: COMPLETED ·Phase: PHASE1
-
A Study of CS0159 in Patients With PBC With Inadequate Response or Intolerance to UDCA
NCT07282353 ·Status: RECRUITING ·Phase: PHASE3
-
Study of Elafibranor in Patients With Primary Biliary Cholangitis (PBC)
NCT04526665 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Fenofibrate in Patients With Primary Biliary Cholangitis (PBC)
NCT06365424 ·Status: RECRUITING ·Phase: PHASE2/PHASE3
-
A Study to Assess Safety and Effectiveness of Elafibranor in Adult Participants With Primary Sclerosing Cholangitis.
NCT05627362 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Ursodeoxycholic Acid Combined With Total Glucosides of Paeony in the Treatment of PBC With AIH Features 1
NCT04618575 ·Status: UNKNOWN ·Phase: PHASE4
-
This Study Will Investigate the Efficacy and Safety of A4250 in Children With PFIC Types 1 or 2
NCT03566238 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of TAK-625 for the Treatment of Progressive Familial Intrahepatic Cholestasis (PFIC)
NCT05543187 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of TAK-781 in Healthy Volunteers and in Participants With Non-Cirrhotic Primary Sclerosing Cholangitis (PSC)
NCT07229911 ·Status: RECRUITING ·Phase: PHASE1
-
A Prospective, Randomized, Placebo-Controlled Pilot Study to Characterize the Intestinal Microbiome and to Evaluate the Safety and Fecal Microbiome Changes Following Administration of Lyophilized PRIM-DJ2727 or Placebo Given Orally in Subjects With Nonalcoholic Fatty Liver Disease
NCT04371653 ·Status: WITHDRAWN ·Phase: PHASE2
-
Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis
NCT02823353 ·Status: COMPLETED ·Phase: PHASE3
-
CS0159 in Chinese Patients With PBC (Primary Biliary Cholangitis)
NCT05896124 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Mesenchymal Stem Cell Transplantation for Refractory Primary Biliary Cholangitis
NCT03668145 ·Status: UNKNOWN ·Phase: NA
-
Study to Evaluate the Effects of Two Doses of Seladelpar (MBX-8025) in Subjects With Primary Biliary Cirrhosis (PBC)
NCT02609048 ·Status: TERMINATED ·Phase: PHASE2
-
Phase 2b Study of NGM282 Extended Treatment in Patients With Primary Biliary Cirrhosis
NCT02135536 ·Status: COMPLETED ·Phase: PHASE2
-
Seladelpar (MBX-8025) in Subjects With Primary Biliary Cholangitis (PBC)
NCT02955602 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of Elafibranor in Adult Japanese Participants With Primary Biliary Cholangitis (PBC)
NCT06730061 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Low-Dose Oral Methotrexate Versus Colchicine for Primary Biliary Cirrhosis
NCT00004748 ·Status: COMPLETED ·Phase: PHASE3
-
A Study of Experimental Medication BMS-986263 in Adults With Advanced Hepatic Fibrosis After Cure of Hepatitis C
NCT03420768 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Test Whether BI 3802876 is Tolerated in People With Compensated Liver Cirrhosis Due to Metabolic Dysfunction- Associated Steatohepatitis (MASH)
NCT07325526 ·Status: RECRUITING ·Phase: PHASE2