Pirfenidone, an Antifibrotic and Antiinflammatory Drug
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|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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|