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NCT00077636 · ClinicalTrials.gov registry record · Phase 4

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

A Phase 4 study, sponsored by Hoffmann-La Roche.

Completed
Registry status
Phase 4
Development phase
1,469
Enrollment target

NCT00077636: Completed Phase 4 study, sponsored by Hoffmann-La Roche.

NCT00077636 is a Phase 4 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 1,469 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (184% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00077636, a Phase 4 study, has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
Phase 4
Development phase
1,469 participants
Enrollment target

Study Summary

This study will evaluate the efficacy and safety of different durations of treatment with PEGASYS combined with ribavirin in patients with CHC genotype 2 or 3 infection who have never previously received interferon (IFN) therapy. The anticipated time on study treatment is 3-12 months and the target sample size is 500+ individuals.

Primary Outcome

SVR was defined as the percentage of participants with undetectable HCV RNA at 24 weeks after the completion of the study treatment. The negative assessment was required to be the last one collected at or after week 36 (ie, on or after study Day 253) for the 16-week treatment group or at or after week 44 (ie, on or after study Day 309) for the 24-week treatment group.

Interventions

  • DRUG Copegus
  • DRUG peginterferon alfa-2a [Pegasys]

Trial Details

FieldValue
Enrollment Target 1,469 participants
Start Date 2003-12
Est. Completion 2006-03
Phase Phase 4
Hoffmann-La Roche

909 total trials

What the finished NCT00077636 record still lists

NCT00077636 is an interventional study that assigns participants to a tested intervention. Its 1,469 participants enrollment target places it among the larger protocols in the corpus, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (184% higher).

The record links to 0 conditions, and to 2 interventions - of which Copegus is the first listed.

NCT00077636 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00077636 about?

NCT00077636 is a clinical study titled "ACCELERATE Study - A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With COPEGUS (Ribavirin) in Interferon-Naive Patients With Chronic Hepatitis C (CHC) Infection.". This study will evaluate the efficacy and safety of different durations of treatment with PEGASYS combined with ribavirin in patients with CHC genotype 2 or 3 infection who have never previously received interferon (IFN) therapy. The anticipated time on study treatment is 3-12 months and the target ...

What is the current status of trial NCT00077636?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 1,469 participants. The study started on 2003-12. Estimated completion is 2006-03.

What interventions are being tested in trial NCT00077636?

The interventions under investigation include: Copegus (DRUG), peginterferon alfa-2a [Pegasys] (DRUG).

Who is sponsoring clinical trial NCT00077636?

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

How this trial's enrollment target compares

Where NCT00077636's enrollment target sits among peer trials

1,469 53rd of 2000 higher than 1,948 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 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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Source: ClinicalTrials.gov NCT00077636, the US trial registry maintained by the National Library of Medicine. NCT00077636 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.