NCT01340573

Evaluating Safety and Efficacy In Hepatitis C Patients After PegIntron Pen Treatment (Study P04896)

Non-Interventional Study Evaluating The Safety and Efficacy In Patients Receiving New PegIntron Pen for Hepatitis C

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 3 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a non-interventional study designed to evaluate the efficacy and safety of combination study drugs in the treatment of participants diagnosed with Chronic Hepatitis C (CHC). CHC participants with confirmed positive hepatitis-C virus (HCV) RNA in plasma, and who have not been previously treated with the Pegylated interferon (PegIntron) Pen, were enrolled into study.

Detailed description

Participants with positive genotype-1 HCV RNA received 48 weeks of treatment of PegIntron Pen plus ribavirin and 24 weeks of follow-up. Participants who were non-genotype-1 HCV RNA positive received 24 weeks of treatment of PegIntron Pen plus ribavirin and 24 weeks of follow-up. Participants were asked to complete a questionnaire to measure the satisfaction and the use of training materials of PegIntron pen using a 1-5 score system provided in the questionnaire. The questionnaire was completed once at first follow-up visit. Efficacy measurements for sustained viral response HCV RNA was collected at week-24 of treatment and at week-24 of follow-up in positive Non-genotype-1 HCV RNA participants. Efficacy measurements for sustained viral response HCV RNA was collected at week-24 and at week-48 of treatment, and at week-24 of follow-up, for positive Genotype-1 HCV RNA participants.

Conditions

• Chronic Hepatitis C

Interventions

Type	Name	Description
DRUG	PegIntron Pen	Peginterferon alfa-2b, 1.5 microgram/kg each week, administered subcutaneously.
DRUG	Ribavirin	Dose is based on body weight. Each tablet of ribavirin is 200mg, and given by oral administration. Participants with body weight of \<65 kg were administered 800 mg of ribavirin daily, body weight of 65 kg-85 kg received 1000 mg daily, and participants with a body weight of \>85 kg received 1200 mg of ribavirin daily.

Timeline

• Start date: 2007-03-23
• Primary completion: 2007-10-29
• Completion: 2007-10-29
• First posted: 2011-04-22
• Last updated: 2024-06-12
• Results posted: 2012-01-30