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Pirfenidone, an Antifibrotic and Antiinflammatory Drug

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02161952
Recruitment Status : Completed
First Posted : June 12, 2014
Last Update Posted : July 9, 2014
Cell Therapy And Technology, S.a. De C.v.
Information provided by (Responsible Party):
Juan Armendáriz-Borunda, University of Guadalajara

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.

Condition or disease Intervention/treatment Phase
Fibrosis Hepatitis C Chronic Drug: Pirfenidone Drug: Matched equivalent placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Pirfenidone, an Antifibrotic and Antiinflammatory Drug for Treatment of Patients With Cirrhosis Due to Hepatitis C Virus. Phase II/III Study
Study Start Date : May 2005
Actual Primary Completion Date : August 2006
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

Drug Information available for: Pirfenidone

Arm Intervention/treatment
Experimental: Pirfenidone
Pirfenidone 400 mg capsules, orally administered thrice daily to yield a daily dose of 1200 mg during two years.
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.
Other Name: 5 methyl-1-phenil-2 (1H)-pyridone

Placebo Comparator: Matched equivalent placebo
Matched equivalent placebo
Drug: Matched equivalent placebo

Primary Outcome Measures :
  1. Fibrosis staging [ Time Frame: 24 months ]
    Fibrosis was evaluated according to Ishak fibrosis staging scale.

Secondary Outcome Measures :
  1. Grade of necroinflammation activity [ Time Frame: 24 months ]
    Necroinflammatory activity was evaluated according to the Ishak modified histological activity index (HAI).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02161952

Sponsors and Collaborators
University of Guadalajara
Cell Therapy And Technology, S.a. De C.v.
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Principal Investigator: Juan Armendariz-Borunda, Ph. D. Head, Molecular Biology and Genomics Department
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Juan Armendáriz-Borunda, Head, Molecular Biology and Genomics Department, CUCS, University of Guadalajara Identifier: NCT02161952    
Other Study ID Numbers: IBMMTG.05
HCG, No. Registry 505/05 ( Registry Identifier: COFEPRIS, No. Registry 05330020020126 )
First Posted: June 12, 2014    Key Record Dates
Last Update Posted: July 9, 2014
Last Verified: June 2014
Keywords provided by Juan Armendáriz-Borunda, University of Guadalajara:
Fibrosis, necroinflammation, hepatitis C chronic
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Pathologic Processes
Flaviviridae Infections
Hepatitis, Chronic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents