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NCT00623428 · ClinicalTrials.gov registry record · Phase 3

A Study of Combination Therapy With PEGASYS (Pegylated Interferon Alfa-2a (40KD)) and Copegus (Ribavirin) in Patients With Chronic Hepatitis C Genotype 2 or 3 Who Do Not Achieve a Rapid Viral Response

A Phase 3 study of Hepatitis C, Chronic, sponsored by Hoffmann-La Roche.

Completed
Registry status
Phase 3
Development phase
235
Enrollment target
20
Study locations

NCT00623428: Completed Phase 3 study of Hepatitis C, Chronic, sponsored by Hoffmann-La Roche.

NCT00623428 is a Phase 3 study of Hepatitis C, Chronic that has completed, run by Hoffmann-La Roche. The registered enrollment target is 235 participants, below the 367-participant average among 26 other Hepatitis C, Chronic trials with a reported enrollment target (36% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00623428, a Phase 3 study of Hepatitis C, Chronic, has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
Phase 3
Development phase
235 participants
Enrollment target
20
Study locations

Study Summary

This study will evaluate the efficacy and safety of peginterferon alfa-2a 40KD + ribavirin combination therapy given for 24 weeks versus 48 weeks in patients with chronic hepatitis C, genotype 2/3.

Primary Outcome

Sustained virological response (SVR) is defined as a single last HCV RNA measurement \<15 IU/ml (measured using the Roche COBAS AmpliPrep / COBAS TaqMan HCV Test) 24 weeks after scheduled treatment completion, defined as Week 44 or later for participants randomized to the 24-week treatment period or Week 68 or later for participants randomized to the 48-week treatment period. Participants without measurements at the end of the 24-week untreated follow-up period were considered non-responders in

Conditions Studied

Hepatitis C, Chronic

Interventions

  • DRUG Ribavirin
  • DRUG peginterferon alfa-2a

Study Locations (20)

California

  • - La Jolla
  • - Lancaster
  • - Long Beach
  • - Los Angeles
  • - Los Angeles
  • - Sacramento
  • - Sacramento
  • - San Diego
  • - Torrance

Florida

  • - Jacksonville
  • - Orlando

Georgia

  • - Atlanta
  • - Marietta

Louisiana

  • - Baton Rouge
  • - Opelousas

Alabama

  • - Birmingham

Colorado

  • - Aurora

Hawaii

  • - Honolulu

Massachusetts

  • - Boston

Trial Details

FieldValue
Enrollment Target 235 participants
Start Date 2008-06
Est. Completion 2012-05
Phase Phase 3
Hoffmann-La Roche

909 total trials

What the finished NCT00623428 record still lists

NCT00623428 is an interventional study that assigns participants to a tested intervention. The registered 235 participants enrollment target is mid-sized for trials with a published cap, below the 367-participant average among 26 other Hepatitis C, Chronic trials with a reported enrollment target (36% lower).

The record links to 1 condition, with Hepatitis C, Chronic appearing as the primary indexed condition, and to 2 interventions - of which Ribavirin is the first listed.

NCT00623428 names 20 study sites across 9 states, led by California, Florida, Georgia.

Frequently Asked Questions

What is clinical trial NCT00623428 about?

NCT00623428 is a clinical study titled "A Study of Combination Therapy With PEGASYS (Pegylated Interferon Alfa-2a (40KD)) and Copegus (Ribavirin) in Patients With Chronic Hepatitis C Genotype 2 or 3 Who Do Not Achieve a Rapid Viral Response". This study will evaluate the efficacy and safety of peginterferon alfa-2a 40KD + ribavirin combination therapy given for 24 weeks versus 48 weeks in patients with chronic hepatitis C, genotype 2/3.

What is the current status of trial NCT00623428?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 235 participants. The study started on 2008-06. Estimated completion is 2012-05.

What conditions does trial NCT00623428 study?

This clinical trial studies the following conditions: Hepatitis C, Chronic.

What interventions are being tested in trial NCT00623428?

The interventions under investigation include: Ribavirin (DRUG), peginterferon alfa-2a (DRUG).

Who is sponsoring clinical trial NCT00623428?

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

Where is trial NCT00623428 being conducted?

This trial has 20 study locations across Alabama, California, Colorado, Florida, Georgia. 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 NCT00623428's enrollment target sits among peer trials

235 10th of 26 higher than 17 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 NCT00623428, the US trial registry maintained by the National Library of Medicine. NCT00623428 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.