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Peginterferon Alfa-2a Plus Ribavirin Combination Treatment in Chronic Hepatitis C Post-Renal Transplant Patients

This study has been completed.
Sponsor:
Collaborators:
Riyadh Military Hospital
King Faisal Specialist Hospital & Research Center
Information provided by (Responsible Party):
Faisal M Sanai, King Abdulaziz Medical City
ClinicalTrials.gov Identifier:
NCT00881582
First received: April 14, 2009
Last updated: September 13, 2012
Last verified: September 2012
  Purpose

There is a distinct lack of published literature on the effect of combination treatment of PEG-interferon and ribavirin on post-renal transplantation hepatitis C virus (HCV) patients. Small case series have been published utilizing conventional interferon and/or ribavirin and the available data is extremely preliminary in nature. A small retrospective series of patients treated with Pegylated interferon and ribavirin published recently suggests that the treatment may be safe and efficacious. Unpublished reports from a few centers within Saudi Arabia also suggest a good safety profile and reasonable efficacy from this form of combination treatment.

The investigators aim to prospectively study the safety and efficacy of PEG-interferon and ribavirin combination therapy in post-renal transplant HCV-infected patients. Towards this 40 patients with histological evidence of liver disease will be recruited and the efficacy of the above medications studied.

The proposed study aims to evaluate the efficacy and safety of PEG-interferon and ribavirin combination therapy in the treatment of chronic HCV in renal transplant patients in a way that will allow management of such patients in an optimized manner.


Condition Intervention Phase
Chronic Hepatitis C
Renal Transplant
Drug: Pegylated interferon alfa-2a plus ribavarin
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Peginterferon Alfa-2a Plus Ribavirin Combination Treatment in Chronic Hepatitis C Post-Renal Transplant Patients

Resource links provided by NLM:


Further study details as provided by King Abdulaziz Medical City:

Primary Outcome Measures:
  • Sustained Virologic Response [ Time Frame: At 24 weeks post completion of treatment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Adverse event rate and number of cases of graft rejection [ Time Frame: Assessment at 4, 12, 24 and 48 weeks on treatment, and 24 weeks post completion of treatment ] [ Designated as safety issue: Yes ]

Enrollment: 32
Study Start Date: January 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pegylated interferon alfa-2a plus ribavarin
Pegylated interferon alfa-2a plus ribavarin for 48 weeks
Drug: Pegylated interferon alfa-2a plus ribavarin
PEG-interferon alfa-2a and ribavirin. Pegylated interferon alfa-2a - standard dose; plus ribavirin - standard dose (determined by creatinine clearance); for 24 to 48 weeks (genotypes 1 & 4: 48 weeks; genotypes 2 & 3: 24 weeks)
Other Names:
  • Pegasys®, F. Hoffman-LaRoche
  • Copegus®, F. Hoffman-LaRoche

  Eligibility

Ages Eligible for Study:   18 Years to 68 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients, male and female, aged 18 - 68 years
  • Post renal transplant patients exceeding one year
  • Anti-HCV (Abbott HCV EIA 2.0, Abbott Diagnostic, Chicago, IL) positive > 6 months AND/OR
  • Detectable serum quantitative HCV-RNA (Cobas Amplicor HCV Monitor v2.0, Roche Molecular Systems, Pleasanton, CA) with lower limit of detection at 50 IU/mL
  • Compensated liver disease with the following minimum hematologic and biochemical criteria:
  • Hemoglobin > 10 g/dL
  • WBC > 3000/mm3 ; granulocyte count > 1,500/mm3
  • Platelet count > 75,000/mm3
  • Albumin within normal limits
  • TFT within normal limits
  • ANA < 1:320
  • Ultrasound of the liver obtained within the preceding 6 months of study entry
  • Liver biopsy prior to entry confirming a histological diagnosis consistent with HCV necroinflammatory score (METAVIR) > 1, and fibrosis score >/= 2.

Exclusion Criteria:

  • Previous treatment with interferon and / or Ribavirin - based therapy for chronic hepatitis C
  • Co-infection with HBV or HIV
  • Chronic alcohol abuse (daily consumption > 20 g/day)
  • Autoimmune or metabolic liver disease liver disease
  • Active drug-induced hepatitis or HAV
  • Decompensated liver disease (Child-Pugh classification B or C) including a past history of decompensation
  • Variceal bleeding
  • Evidence of severe retinopathy (e.g. CMV retinitis, macula degeneration) or clinically relevant ophthalmological disorder due to diabetes mellitis or hypertension
  • Neoplastic disease
  • Patients with a value of alpha-fetoprotein >100 ng/mL will be excluded from the study until imaging studies confirm the absence of HCC. Presence of HCC, as determined by other means will also exclude the patient from histological sampling.
  • Patients with documented or presumed coronary artery disease or cerebrovascular disease should not be enrolled if, in the judgment of the investigator, an acute decrease in hemoglobin by up to 4 g/dL (40 g/L) (as may be seen with ribavirin therapy) would not be well-tolerated
  • History of severe psychiatric disease, especially depression. Severe psychiatric disease is defined as treatment with an antidepressant medication or a major tranquilizer at therapeutic doses for major depression or psychosis, respectively, for at least 3 months at any previous time or any history of the following: a suicidal attempt, hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease
  • Evidence of drug abuse (including excessive alcohol consumption) within one year of study entry
  • Current pregnancy, ongoing breast feeding or unwilling to have contraception
  • Bleeding or clotting diatheses
  • Recent history of renal allograft rejection (< 6 months)
  • Inability or unwillingness to provide informed consent or abide by the requirements of the study.
  • History or other evidence of severe illness or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study.
  • History of organ transplantation, other than kidney, with an existing functional graft.
  • Patients requiring dialysis or in whom dialysis is impending.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00881582

Locations
Saudi Arabia
King Faisal Specialist Hospital & Research Centre
Riyadh, Saudi Arabia, 11159
Riyadh Military Hospital
Riyadh, Saudi Arabia, 11159
Sponsors and Collaborators
King Abdulaziz Medical City
Riyadh Military Hospital
King Faisal Specialist Hospital & Research Center
Investigators
Principal Investigator: Faisal M Sanai, MBBS, MD Riyadh Military Hospital
  More Information

No publications provided by King Abdulaziz Medical City

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Faisal M Sanai, Consultant Hepatologist & Liver Transplant Physician, King Abdulaziz Medical City
ClinicalTrials.gov Identifier: NCT00881582     History of Changes
Other Study ID Numbers: RMH-01-09
Study First Received: April 14, 2009
Last Updated: September 13, 2012
Health Authority: Saudi Arabia: Research Advisory Council

Keywords provided by King Abdulaziz Medical City:
Hepatitis c
Renal transplantation
Pegylated interferon

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Chronic
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Interferon-alpha
Interferons
Peginterferon alfa-2a
Ribavirin
Anti-Infective Agents
Antimetabolites
Antineoplastic Agents
Antiviral Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014