Ursodiol-Methotrexate for Primary Biliary Cirrhosis
NCT00006168 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL
Last updated 2010-01-13
Summary
The major thrust is to determine whether treatment of patients with Primary Biliary Cirrhosis (PBC) with Ursodiol (Ursodeoxycholic Acid-UDCA) plus methotrexate (MTX) is more effective than treatment with UDCA alone.
Conditions
- Liver Cirrhosis, Biliary
Interventions
- DRUG
-
Methotrexate
Sponsors & Collaborators
-
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
lead NIH
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
Eligibility
- Min Age
- 20 Years
- Max Age
- 69 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 1994-01-31
- Completion
- 2004-03-31
Countries
- United States
Study Locations
More Related Trials
-
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Repeat Doses of GSK2330672 Administration in Subjects With Primary Biliary Cirrhosis (PBC) and Symptoms of Pruritus
NCT01899703 ·Status: COMPLETED ·Phase: PHASE2
-
Phase 3 Study of Bezafibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis
NCT01654731 ·Status: COMPLETED ·Phase: PHASE3
-
A Multicenter, Randomized, Controlled Trial of Prednisone Combined With Ursodeoxycholic Acid in the Treatment of Primary Biliary Cholangitis With Moderate to Severe Interface Hepatitis Characteristics
NCT06591468 ·Status: ENROLLING_BY_INVITATION ·Phase: PHASE2/PHASE3
-
Study of Obeticholic Acid(OCA) Combination With Ursodeoxycholic Acid (UDCA) in Patients With Primay Biliary Cirrhosis (PBC)
NCT04956328 ·Status: UNKNOWN ·Phase: PHASE3
-
Study of Abatacept (Orencia) to Treat Primary Biliary Cirrhosis
NCT02078882 ·Status: COMPLETED ·Phase: PHASE4
-
Study to Assess Safety & Efficacy of GKT137831 in Patients With Primary Biliary Cholangitis Receiving Ursodiol.
NCT03226067 ·Status: COMPLETED ·Phase: PHASE2
-
Ursodeoxycholic Acid Combined With Total Glucosides of Paeony in the Treatment of PBC With AIH Features 1
NCT04618575 ·Status: UNKNOWN ·Phase: PHASE4
-
Seladelpar (MBX-8025) in Subjects With Primary Biliary Cholangitis (PBC)
NCT02955602 ·Status: COMPLETED ·Phase: PHASE2
-
Trial of High-dose Urso in Primary Sclerosing Cholangitis
NCT00059202 ·Status: TERMINATED ·Phase: PHASE2/PHASE3
-
Ursodeoxycholic Acid Combined With Low Dose Glucocorticoid in the Treatment of PBC With AIH Features II
NCT04617561 ·Status: UNKNOWN ·Phase: PHASE4
-
Fenofibrate Combined With Ursodeoxycholic Acid in Subjects With Primary Biliary Cholangitis
NCT05751967 ·Status: RECRUITING ·Phase: PHASE3
-
Fuzhenghuayu in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis
NCT02916290 ·Status: UNKNOWN ·Phase: PHASE3
-
Real-World Data Study to Evaluate the Effectiveness of OCA on Hepatic Outcomes in PBC Patients
NCT05292872 ·Status: COMPLETED
-
Study of INT 747 in Combination With URSO in Patients With Primay Biliary Cirrhosis (PBC)
NCT00550862 ·Status: TERMINATED ·Phase: PHASE2
-
Study to Evaluate the Effects of Two Doses of Seladelpar (MBX-8025) in Subjects With Primary Biliary Cirrhosis (PBC)
NCT02609048 ·Status: TERMINATED ·Phase: PHASE2
-
A Real-World Data Study to Evaluate the Effectiveness of OCA on Hepatic Outcomes in PBC Patients
NCT05293938 ·Status: WITHDRAWN
-
RESPONSE: Response to Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and an Inadequate Control to or an Intolerance to Ursodeoxycholic Acid (UDCA)
NCT04620733 ·Status: COMPLETED ·Phase: PHASE3
-
Fenofibrate in Combination With Ursodeoxycholic Acid in Primary Biliary Cirrhosis
NCT02823353 ·Status: COMPLETED ·Phase: PHASE3
-
Monitoring the Response of Combination Ursodiol and Seladelpar Treatment
NCT07122206 ·Status: NOT_YET_RECRUITING
-
Fuzhenghuayu for Patients With PBC Who Had An Inadequate Response to Ursodeoxycholic Acid
NCT02916641 ·Status: UNKNOWN ·Phase: PHASE3
-
Clinical Research of Tapering UDCA in PBC Patients With a Complete Response
NCT04650243 ·Status: RECRUITING ·Phase: PHASE4
-
Fenofibrate for Patients With Primary Biliary Cirrhosis Who Had An Inadequate Response to Ursodeoxycholic Acid
NCT02823366 ·Status: UNKNOWN ·Phase: PHASE3
-
Moexipril for Primary Biliary Cirrhosis
NCT00588302 ·Status: COMPLETED ·Phase: PHASE2
-
Phase 2 Study to Evaluate LUM001 in Combination With Ursodeoxycholic Acid in Patients With Primary Biliary Cirrhosis
NCT01904058 ·Status: COMPLETED ·Phase: PHASE2
-
Combination Antiretroviral Therapy (cART) for PBC
NCT03954327 ·Status: COMPLETED ·Phase: PHASE2