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Pirfenidone, an Antifibrotic and Antiinflammatory Drug

NCT02161952 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2014-07-09

No results posted yet for this study

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.

Conditions

Interventions

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.

DRUG

Matched equivalent placebo

Sponsors & Collaborators

  • Cell Therapy And Technology, S.a. De C.v.

    collaborator INDUSTRY

  • University of Guadalajara

    lead OTHER

Principal Investigators

  • Juan Armendariz-Borunda, Ph. D. · Head, Molecular Biology and Genomics Department

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2005-05-31
Primary Completion
2006-08-31
Completion
2007-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02161952 on ClinicalTrials.gov