Pirfenidone, an Antifibrotic and Antiinflammatory Drug
|ClinicalTrials.gov Identifier: NCT02161952|
Recruitment Status : Completed
First Posted : June 12, 2014
Last Update Posted : July 9, 2014
|Condition or disease||Intervention/treatment||Phase|
|Fibrosis Hepatitis C Chronic||Drug: Pirfenidone Drug: Matched equivalent placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Pirfenidone, an Antifibrotic and Antiinflammatory Drug for Treatment of Patients With Cirrhosis Due to Hepatitis C Virus. Phase II/III Study|
|Study Start Date :||May 2005|
|Actual Primary Completion Date :||August 2006|
|Actual Study Completion Date :||August 2007|
Pirfenidone 400 mg capsules, orally administered thrice daily to yield a daily dose of 1200 mg during two years.
Pirfenidone was supplied orally in 400 mg gel capsules three times daily (every 8 hours) for a full dosage of 1200 mg daily during 24 months.
Other Name: 5 methyl-1-phenil-2 (1H)-pyridone
Placebo Comparator: Matched equivalent placebo
Matched equivalent placebo
Drug: Matched equivalent placebo
- Fibrosis staging [ Time Frame: 24 months ]Fibrosis was evaluated according to Ishak fibrosis staging scale.
- Grade of necroinflammation activity [ Time Frame: 24 months ]Necroinflammatory activity was evaluated according to the Ishak modified histological activity index (HAI).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02161952
|Principal Investigator:||Juan Armendariz-Borunda, Ph. D.||Head, Molecular Biology and Genomics Department|