NCT00881582

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: King Abdulaziz Medical City · Other Government
• Sex: All
• Age: 18 Years – 68 Years
• Healthy volunteers: Not accepted

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 Unpublished reports from a few centers within Saudi Arabia also suggest a good safety profile and reasonable efficacy from this form of combination treatment.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

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2009-01-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2009-04-15
• Last updated: 2012-09-14

Locations

2 sites across 1 country: Saudi Arabia