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

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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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01340573 on ClinicalTrials.gov