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A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With COPEGUS (Ribavirin) in Interferon-Naive Patients With Chronic Hepatitis C Infection (CHC).
NCT00077649 · View on ClinicalTrials.gov ↗
Study Summary
The effects of treatment with different doses of PEGASYS in combination with different doses of ribavirin will be evaluated in patients with CHC genotype 1 who have a high viral titer, body weight greater than 85kg (187lbs) and no prior treatment with interferon. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.
Conditions Studied
Interventions
- DRUG ribavirin [Copegus]
- DRUG peginterferon alfa-2a (PEG-IFN alfa-2a) [Pegasys]
Study Locations (20)
California
- — La Jolla
- — Long Beach
- — San Diego
- — San Diego
Florida
- — Bradenton
- — Gainesville
- — Jacksonville
- — Wellington
North Carolina
- — Chapel Hill
- — Statesville
Pennsylvania
- — Philadelphia
- — Pittsburgh
Connecticut
- — Farmington
Hawaii
- — Honolulu
Illinois
- — Chicago
Iowa
- — Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 188 participants |
| Start Date | 2004-01 |
| Est. Completion | 2005-12 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00077649
The ClinicalTrials.gov registry entry for NCT00077649 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 188 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 758 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Hepatitis C, Chronic appearing as the primary indexed condition, and to 2 interventions — of which ribavirin [Copegus] is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT00077649 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, Florida, North Carolina. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT00077649 about?
NCT00077649 is a clinical study titled "A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With COPEGUS (Ribavirin) in Interferon-Naive Patients With Chronic Hepatitis C Infection (CHC).". The effects of treatment with different doses of PEGASYS in combination with different doses of ribavirin will be evaluated in patients with CHC genotype 1 who have a high viral titer, body weight greater than 85kg (187lbs) and no prior treatment with interferon. The anticipated time on study treatm...
What is the current status of trial NCT00077649?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 188 participants. The study started on 2004-01. Estimated completion is 2005-12.
What conditions does trial NCT00077649 study?
This clinical trial studies the following conditions: Hepatitis C, Chronic. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT00077649?
The interventions under investigation include: ribavirin [Copegus] (DRUG), peginterferon alfa-2a (PEG-IFN alfa-2a) [Pegasys] (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT00077649?
This trial is sponsored by Hoffmann-La Roche, which has 758 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT00077649 being conducted?
This trial has 20 study locations across California, Connecticut, Florida, Hawaii, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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