PEG-Interferon a-2b + Ribavirin for Treatment of Patients With Chronic Hepatitis C Who Have Previously Failed to Achieve a Sustained Virologic Response Following Interferon Alfa or Interferon a-2b + Ribavirin Therapy
Public ClinicalTrials.gov record NCT00215865. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
HRN 003PEG-Interferon a-2b + Ribavirin for Treatment of Patients With Chronic Hepatitis C Who Have Previously Failed to Achieve a Sustained Virologic Response Following Interferon Alfa or Interferon a-2b + Ribavirin Therapy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
HRN-003 STUDY SYNOPSIS OBJECTIVE: To compare the Sustained Virologic Response (SVR) of PEGIntron plus ribavirin among patients receiving a fixed dose of PEGIntron versus weighted-adjusted dosing. OVERVIEW OF STUDY DESIGN: This is a multi-center, randomized, open-label clinical trial using PEGIntron weight-adjusted dose by subcutaneous injection weekly + ribavirin by mouth twice daily for 48 weeks OR PEGIntron fixed dose by subcutaneous injection weekly + ribavirin by mouth twice daily for 48 weeks. STUDY POPULATION: 600 Adult patients with chronic hepatitis C virus infection who have previously failed to achieve a sustained virologic response following interferon alfa or interferon alfa-2b plus ribavirin therapy. DOSAGE AND ADMINISTRATION: Eligible participants will be randomized to receive PEGIntron weight-adjusted dose (1.5 mg/kg) by subcutaneous injection weekly + ribavirin 400 mg by mouth twice daily for 48 weeks OR PEGIntron fixed dose (150 mg if weight \> than 80 kg or 100 mg if weight \< 80 KG) by subcutaneous injection weekly + ribavirin 400 mg by mouth twice daily for 48 weeks. EFFICACY EVALUATIONS: Laboratory analysis, quality of life assessments, and change in study medication doses will be obtained. SAFETY EVALUATIONS: Assessment of laboratory evaluations, vital signs, incidence and severity of adverse experiences and progression of disease, as measured by HCV viral load. STUDY DESIGN This is a treatment protocol to evaluate the antiviral efficacy, safety and tolerability polyethylene glycol (PEG) conjugated interferon alfa-2b (PEGIntron) for the treatment of chronic hepatitis C virus infection in patients who have previously failed to achieve a sustained virologic response following interferon alfa or interferon alfa-2b plus ribavirin therapy. Patients will be stratified according to their response to the previous course of therapy (i.e. non-reponse or relapse virologic pattern This is a multi-center, randomized, open-label clinical trial that will involve approximately 25 sites with an anticipated enrollment of 600 patients over a six-month period. Eligible participants will be randomized to receive PEGIntron weight-adjusted dose (1.5 mg/kg) by subcutaneous injection weekly + ribavirin 400 mg by mouth twice daily for 48 weeks OR PEGIntron fixed dose (150 mg if weight \> than 80 kg or 100 mg if weight \< 80 KG) by subcutaneous injection weekly + ribavirin 400 mg by mouth twice daily for 48 weeks. * Group A: PEGIntron weight -adjusted dose (1.5 mg/kg) by subcutaneous injection weekly + ribavirin 400 mg by mouth twice daily for 48 weeks (Total therapy x 48weeks). * Group B: PEGIntron fixed dose (150 mg if weight \> than 80 kg or 100 mg if weight \< 80 KG) by subcutaneous injection weekly + ribavirin 400 mg by mouth twice daily for an additional 48 weeks (Total therapy x 48 weeks).
Study identification
- NCT ID
- NCT00215865
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 600 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Not listed
- Primary completion
- Not listed
- Completion
- Not listed
- Last update posted
- Sep 21, 2005
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Johns Hopkins Univesity School of Medicine | Baltimore | Maryland | 21287 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00215865, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 21, 2005 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00215865 live on ClinicalTrials.gov.