Fibrosis, Hepatitis C Chronic
Conditions
Keywords
Fibrosis, necroinflammation, hepatitis C chronic
Brief summary
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.
Interventions
DRUGPirfenidone
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.
DRUGMatched equivalent placebo
Sponsors
Cell Therapy And Technology, S.a. De C.v.
University of Guadalajara
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fibrosis staging | 24 months | Fibrosis was evaluated according to Ishak fibrosis staging scale. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Grade of necroinflammation activity | 24 months | Necroinflammatory activity was evaluated according to the Ishak modified histological activity index (HAI). |
Outcome results
None listed