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Pirfenidone in cirrhosis due to hepatitis C virus
NCT02161952Phase 2
Key facts
- Status
- Completed
- Start
- May 2005
- Primary completion
- Aug 2006
- Sponsor
- Universidad de Guadalajara
- Modality
- Small Molecules
- Drugs
- pirfenidone
- Conditions
- Liver cirrhosis (LC)hepatitis C virus infection
01
Overview
Phase 2, randomised, double-blind trial of pirfenidone in Liver cirrhosis (LC) and hepatitis C virus infection, sponsored by Universidad de Guadalajara. Primary endpoint: Fibrosis staging at 24 months. Started May 2005; status: completed.
02
Design
- Study design
- RandomizedDouble-blind
03
Who it enrols
Patients with advanced liver disease (cirrhosis) due to chronic HCV infection, positive for anti-HCV and HCV RNA, willing to undergo liver biopsies, and abstinent from alcohol and certain medications.
04
Endpoints
Primary
Fibrosis staging
Secondary
Grade of necroinflammation activity
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