Pirfenidone, an Antifibrotic and Antiinflammatory Drug

Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02161952
• Other study ID #: IBMMTG.05
• Secondary ID: HCG, No. Registr
• Status: Completed
• Phase: Phase 2
• First received: June 10, 2014
• Last updated: July 7, 2014
• Start date: May 2005
• Est. completion date: August 2007

Study information

• Verified date: June 2014
• Source: University of Guadalajara
• Contact: n/a
• Is FDA regulated: No
• Health authority: México: Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: August 2007
• Est. primary completion date: August 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibrosis
• Hepatitis
• Hepatitis C
• Hepatitis C Chronic
• Hepatitis C, Chronic

Intervention

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.
• Matched equivalent placebo

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Guadalajara	Cell Therapy And Technology, S.a. De C.v.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fibrosis staging	Fibrosis was evaluated according to Ishak fibrosis staging scale.	24 months	No
Secondary	Grade of necroinflammation activity	Necroinflammatory activity was evaluated according to the Ishak modified histological activity index (HAI).	24 months	No