Peginterferon Alfa-2a Plus Ribavirin Combination Treatment in Chronic Hepatitis C Post-Renal Transplant Patients
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|ClinicalTrials.gov Identifier: NCT00881582|
Recruitment Status : Completed
First Posted : April 15, 2009
Last Update Posted : September 14, 2012
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 Unpublished reports from a few centers within Saudi Arabia also suggest a good safety profile and reasonable efficacy from this form of combination treatment.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 or disease||Intervention/treatment||Phase|
|Chronic Hepatitis C Renal Transplant||Drug: Pegylated interferon alfa-2a plus ribavarin||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Peginterferon Alfa-2a Plus Ribavirin Combination Treatment in Chronic Hepatitis C Post-Renal Transplant Patients|
|Study Start Date :||January 2009|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2011|
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)
- Sustained Virologic Response [ Time Frame: At 24 weeks post completion of treatment ]
- 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 ]
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 ClinicalTrials.gov identifier (NCT number): NCT00881582
|King Faisal Specialist Hospital & Research Centre|
|Riyadh, Saudi Arabia, 11159|
|Riyadh Military Hospital|
|Riyadh, Saudi Arabia, 11159|
|Principal Investigator:||Faisal M Sanai, MBBS, MD||Riyadh Military Hospital|