Trial | NCT02161952  Report issue

Title

Pirfenidone, an Antifibrotic and Antiinflammatory Drug
Pirfenidone, an Antifibrotic and Antiinflammatory Drug for Treatment of Patients With Cirrhosis Due to Hepatitis C Virus. Phase II/III Study

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    pirfenidone ...

  • Study Participants

    150
The aim of this study was to assess whether two-year treatment with Pirfenidone influence necro-inflammation, fibrosis and steatosis in patients with chronic hepatitis C.
Study Started
May 31
2005
Primary Completion
Aug 31
2006
Study Completion
Aug 31
2007
Last Update
Jul 09
2014
Estimate

Drug Pirfenidone

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 names: 5 methyl-1-phenil-2 (1H)-pyridone

Drug Matched equivalent placebo

Pirfenidone Experimental

Pirfenidone 400 mg capsules, orally administered thrice daily to yield a daily dose of 1200 mg during two years.

Matched equivalent placebo Placebo Comparator

Matched equivalent placebo

Criteria 

Inclusion Criteria:

Patients with established advanced liver disease caused by hepatitis C virus (HCV) chronic infection defined by a positive test for anti-HCV antibodies and detectable serum HCV RNA (Amplicor HCV 2.0 polymerase chain reaction (PCR) assay).
Sign an informed consent form to allow the collection of liver biopsies before and after treatment.
No antifibrotic, antiviral or immunosuppressive drugs for at least 6 months before starting pirfenidone therapy.
No alcohol intake for at least 6 months before nor during Pirfenidone (PFD) treatment.

Exclusion Criteria:

Patients with clinical contraindications to hepatic biopsy
No Results Posted