Pirfenidone, an Antifibrotic and Antiinflammatory Drug

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2007-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Fibrosis Hepatitis C Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Pirfenidone

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

Group Type EXPERIMENTAL

Pirfenidone

Intervention Type DRUG

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.

Matched equivalent placebo

Group Type PLACEBO_COMPARATOR

Matched equivalent placebo

Intervention Type DRUG

Interventions

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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.

Intervention Type DRUG

Matched equivalent placebo

Intervention Type DRUG

Other Intervention Names

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

Eligibility Criteria

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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.