Paeoniflorin Combination of Hepatoprotective Drugs Versus Hepatoprotective Drugs Only for Auto-immune Hepatitis
NCT02878863 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL
Last updated 2017-07-13
Summary
An open-label,prospective, randomized pilot study to evaluate the efficacy, safety and tolerability of paeoniflorin, for the treatment of autoimmune hepatitis (AIH) with mild necroinflammatory activity on liver biopsy.
Conditions
- Hepatitis, Autoimmune
Interventions
- DRUG
-
Paeoniflorin + phosphatidylcholine or silymarin
- DRUG
-
Phosphatidylcholine or silymarin
Sponsors & Collaborators
-
Xiaoli Fan
lead OTHER
Principal Investigators
-
Li Yang, MD · West China Hospital,Chengdu, Sichuan, China
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 20 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-08-31
- Primary Completion
- 2017-03-31
- Completion
- 2017-07-31
Countries
- China
Study Locations
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