Pirfenidone, an Antifibrotic and Antiinflammatory Drug

NCT02161952 | Completed Phase 2 DMC

• 2 other identifiers: IBMMTG.05HCG, No. Registry 505/05
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Fibrosis; Hepatitis C Chronic

Keywords

Fibrosis, necroinflammation, hepatitis C chronic

Outcome Measures

Primary Outcomes (1)

• Fibrosis staging

  Fibrosis was evaluated according to Ishak fibrosis staging scale.

  24 months

Secondary Outcomes (1)

• Grade of necroinflammation activity

  24 months

Study Arms (2)

Pirfenidone

EXPERIMENTAL

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

Drug: Pirfenidone

Matched equivalent placebo

PLACEBO COMPARATOR

Matched equivalent placebo

Drug: Matched equivalent placebo

Interventions

Pirfenidone 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.

Also known as: 5 methyl-1-phenil-2 (1H)-pyridone

Pirfenidone

Matched equivalent placebo DRUG

Matched equivalent placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with clinical contraindications to hepatic biopsy

Sponsors & Collaborators

• University of Guadalajara: lead
• Cell Therapy And Technology, S.a. De C.v.: collaborator

Related Publications (1)

• Flores-Contreras L, Sandoval-Rodriguez AS, Mena-Enriquez MG, Lucano-Landeros S, Arellano-Olivera I, Alvarez-Alvarez A, Sanchez-Parada MG, Armendariz-Borunda J. Treatment with pirfenidone for two years decreases fibrosis, cytokine levels and enhances CB2 gene expression in patients with chronic hepatitis C. BMC Gastroenterol. 2014 Jul 27;14:131. doi: 10.1186/1471-230X-14-131.

  PMID: 25064094 DERIVED

MeSH Terms

Conditions

Fibrosis; Hepatitis C, Chronic

Interventions

pirfenidone

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes

Study Officials

• Juan Armendariz-Borunda, Ph. D.

  Head, Molecular Biology and Genomics Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Molecular Biology and Genomics Department, CUCS

Study Record Dates

• First Submitted: June 10, 2014
• First Posted: June 12, 2014
• Study Start: May 1, 2005
• Primary Completion: August 1, 2006
• Study Completion: August 1, 2007
• Last Updated: July 9, 2014

Record last verified: 2014-06