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NCT00077649 · ClinicalTrials.gov registry record · Phase 4

A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With COPEGUS (Ribavirin) in Interferon-Naive Patients With Chronic Hepatitis C Infection (CHC).

A Phase 4 study of Hepatitis C, Chronic, sponsored by Hoffmann-La Roche.

Completed
Registry status
Phase 4
Development phase
188
Enrollment target
20
Study locations

NCT00077649: Completed Phase 4 study of Hepatitis C, Chronic, sponsored by Hoffmann-La Roche.

NCT00077649 is a Phase 4 study of Hepatitis C, Chronic that has completed, run by Hoffmann-La Roche. The registered enrollment target is 188 participants, below the 369-participant average among 26 other Hepatitis C, Chronic trials with a reported enrollment target (49% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00077649, a Phase 4 study of Hepatitis C, Chronic, has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
Phase 4
Development phase
188 participants
Enrollment target
20
Study locations

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.

Primary Outcome

Viral loads (quantitative HCV RNA) collected during the initial 24 weeks were first logarithmically (based 10) transformed. Results falling below the assay sensitivity level were set to the assay sensitivity level before the analyses. Thus, a qualitative HCV RNA negative result was set to 50 IU/mL (or 100 copies/mL). A qualitative HCV RNA positive result along with an unquantifiable HCV RNA result from the quantitative assay corresponded to a numeric HCV RNA result of 600 IU/mL (or 1000 copies/m

Conditions Studied

Hepatitis C, Chronic

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

FieldValue
Enrollment Target 188 participants
Start Date 2004-01
Est. Completion 2005-12
Phase Phase 4
Hoffmann-La Roche

909 total trials

What the finished NCT00077649 record still lists

NCT00077649 is an interventional study that assigns participants to a tested intervention. The registered 188 participants enrollment target is mid-sized for trials with a published cap, below the 369-participant average among 26 other Hepatitis C, Chronic trials with a reported enrollment target (49% lower).

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.

NCT00077649 names 20 study sites across 12 states, led by California, Florida, North Carolina.

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.

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).

Who is sponsoring clinical trial NCT00077649?

This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.

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.

Learn More About Clinical Trials

Similar trials for Hepatitis C, Chronic

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00077649's enrollment target sits among peer trials

188 12th of 26 higher than 15 of 26 other Hepatitis C, Chronic trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Hepatitis C, Chronic trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT00077649, the US trial registry maintained by the National Library of Medicine. NCT00077649 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.