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NCT00411385 · ClinicalTrials.gov registry record · Phase 3

Efficacy of Albumin Interferon Alfa-2b With Ribavirin Compared to Peg-IFN Alfa-2a With Ribavirin in IFN Naive Patients Geno2/3

A Phase 3 study of Chronic Hepatitis C, sponsored by Human Genome Sciences.

Completed
Registry status
Phase 3
Development phase
933
Enrollment target
20
Study locations

NCT00411385 is a Phase 3 study of Chronic Hepatitis C that has completed, run by Human Genome Sciences. The registered enrollment target is 933 participants, above the 156-participant average among 16 other Chronic Hepatitis C trials with a reported enrollment target (498% higher). The trial reports 20 study locations across 12 states.

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The verdict

NCT00411385, a Phase 3 study of Chronic Hepatitis C, has completed, sponsored by Human Genome Sciences.

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

Study Summary

This is a phase 3, randomized, multi-center study to evaluate the efficacy and safety of albumin interferon alfa-2b (alb-IFN)in combination with ribavirin compared with peginterferon alfa-2a (PEGASYS or PEG-IFNa2a) in combination with ribavirin in subjects with chronic hepatitis C, genotype 2/3 who are IFNa treatment naive.

Conditions Studied

Chronic Hepatitis C

Interventions

  • DRUG Ribavirin
  • DRUG albumin interferon alfa-2b
  • DRUG peginterferon alfa-2a

Study Locations (20)

Florida

  • University of Florida-Gainesville - Gainesville
  • Shands Jacksonville Medical Center - Jacksonville
  • Mayo Clinic Transplant Center - Jacksonville
  • University of Miami - Miami

New York

  • New York Hospital - Cornell - New York
  • Faculty Practice Associates - New York
  • NY Presbyterian Medical Center - Columbia Univ. Med Center - New York
  • Bronx VA Medical Center - The Bronx

California

  • Scripps Clinic - La Jolla
  • California Pacific Medical Center - San Francisco

Georgia

  • Atlanta Gastroenterology Associates - Atlanta
  • GI of Atlanta - Atlanta

Arizona

  • Mayo Clinic Hospital - Phoenix

Colorado

  • University of Colorado - Denver

Illinois

  • University of Chicago Hospital - Chicago

Maryland

  • Johns Hopkins Center for Viral Hepatits - Baltimore

Trial Details

FieldValue
Enrollment Target 933 participants
Start Date 2007-02
Est. Completion 2008-10
Phase Phase 3

Sponsor

Human Genome Sciences

17 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT00411385

The ClinicalTrials.gov registry entry for NCT00411385 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 933 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 156-participant average among 16 other Chronic Hepatitis C trials with a reported enrollment target (498% higher). The listed sponsor is Human Genome Sciences, which has 17 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Chronic Hepatitis C appearing as the primary indexed condition, and to 3 interventions - of which Ribavirin is the first listed.

NCT00411385 reports 20 study locations spanning 12 distinct geographic areas - top geographies include Florida, New York, California.

Frequently Asked Questions

What is clinical trial NCT00411385 about?

NCT00411385 is a clinical study titled "Efficacy of Albumin Interferon Alfa-2b With Ribavirin Compared to Peg-IFN Alfa-2a With Ribavirin in IFN Naive Patients Geno2/3". This is a phase 3, randomized, multi-center study to evaluate the efficacy and safety of albumin interferon alfa-2b (alb-IFN)in combination with ribavirin compared with peginterferon alfa-2a (PEGASYS or PEG-IFNa2a) in combination with ribavirin in subjects with chronic hepatitis C, genotype 2/3 who ...

What is the current status of trial NCT00411385?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 933 participants. The study started on 2007-02. Estimated completion is 2008-10.

What conditions does trial NCT00411385 study?

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

What interventions are being tested in trial NCT00411385?

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

Who is sponsoring clinical trial NCT00411385?

This trial is sponsored by Human Genome Sciences, which has 17 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00411385 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. 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.