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

NCT00881582 | Completed Phase 4 DMC

• 1 other identifier: RMH-01-09
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

Brief Summary

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 Unpublished reports from a few centers within Saudi Arabia also suggest a good safety profile and reasonable efficacy from this form of combination treatment.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.

Conditions

Chronic Hepatitis C; Renal Transplant

Keywords

Hepatitis c; Renal transplantation; Pegylated interferon

Outcome Measures

Primary Outcomes (1)

• Sustained Virologic Response

  At 24 weeks post completion of treatment

Secondary Outcomes (1)

• Adverse event rate and number of cases of graft rejection

  Assessment at 4, 12, 24 and 48 weeks on treatment, and 24 weeks post completion of treatment

Study Arms (1)

Pegylated interferon alfa-2a plus ribavarin

EXPERIMENTAL

Pegylated interferon alfa-2a plus ribavarin for 48 weeks

Drug: Pegylated interferon alfa-2a plus ribavarin

Interventions

Pegylated interferon alfa-2a plus ribavarin DRUG

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)

Also known as: Pegasys®, F. Hoffman-LaRoche, Copegus®, F. Hoffman-LaRoche

Pegylated interferon alfa-2a plus ribavarin

Eligibility Criteria

• Age: 18 Years - 68 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• King Abdulaziz Medical City: lead
• Riyadh Military Hospital: collaborator
• King Faisal Specialist Hospital & Research Center: collaborator

Study Sites (2)

King Faisal Specialist Hospital & Research Centre

Riyadh, 11159, Saudi Arabia

Location

Riyadh Military Hospital

Riyadh, 11159, Saudi Arabia

Location

Related Publications (1)

• Sanai FM, Mousa D, Al-Mdani A, Al-Shoail G, Al-Ashgar H, Al Meshari K, Al-Qahtani A, Saadeh M, Bzeizi KI, Aleid H. Safety and efficacy of peginterferon-alpha2a plus ribavirin treatment in renal transplant recipients with chronic hepatitis C. J Hepatol. 2013 Jun;58(6):1096-103. doi: 10.1016/j.jhep.2013.02.004. Epub 2013 Feb 18.

  PMID: 23428875 DERIVED

MeSH Terms

Conditions

Hepatitis C, Chronic; Hepatitis C

Interventions

peginterferon alfa-2a; Ribavirin

Condition Hierarchy (Ancestors)

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; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Faisal M Sanai, MBBS, MD

  Riyadh Military Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Hepatologist & Liver Transplant Physician

Study Record Dates

• First Submitted: April 14, 2009
• First Posted: April 15, 2009
• Study Start: January 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: September 14, 2012

Record last verified: 2012-09

Locations

SA (2)