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COMPLETED Phase 3

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

NCT00411385 · View on ClinicalTrials.gov ↗

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

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

4 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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 933 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Human Genome Sciences, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT00411385 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Florida, New York, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00411385?

The interventions under investigation include: Ribavirin (DRUG), albumin interferon alfa-2b (DRUG), peginterferon alfa-2a (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT00411385?

This trial is sponsored by Human Genome Sciences, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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