Evaluating Safety and Efficacy In Hepatitis C Patients After PegIntron Pen Treatment (Study P04896)
NCT01340573 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 3
Last updated 2024-06-12
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.
Conditions
- Chronic Hepatitis C
Interventions
- 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.
Sponsors & Collaborators
- lead INDUSTRY
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-03-23
- Primary Completion
- 2007-10-29
- Completion
- 2007-10-29
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