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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 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.

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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.

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

Sponsor

Hoffmann-La Roche

909 total trials

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What the Registry Record Tells You About NCT00077649

The ClinicalTrials.gov registry entry for NCT00077649 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 188 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 369-participant average among 26 other Hepatitis C, Chronic trials with a reported enrollment target (49% lower). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 12 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.