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NCT01455090 · ClinicalTrials.gov registry record · Phase 2

Study to Determine the Effectiveness and Safety of a Three Drug Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) Infected Patients Not Previously Treated With Currently Available Medications

A Phase 2 study of Chronic Hepatitis C, sponsored by Bristol-Myers Squibb.

Completed
Registry status
Phase 2
Development phase
320
Enrollment target
20
Study locations

NCT01455090 is a Phase 2 study of Chronic Hepatitis C that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 320 participants, above the 194-participant average among 16 other Chronic Hepatitis C trials with a reported enrollment target (65% higher). The trial reports 20 study locations across 12 states.

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The verdict

NCT01455090, a Phase 2 study of Chronic Hepatitis C, has completed, sponsored by Bristol-Myers Squibb.

COMPLETED
Registry status
Phase 2
Development phase
320 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to estimate the rate of sustained virologic response (SVR) SVR12, where SVR12 is defined as HCV RNA \< LOQ (detectable or undetectable) 12 weeks post-treatment in Genotype 1 \& Genotype 4 treatment naive patients, and Genotype (GT1) infected patients who are prior null responders to pegIFN/ribavirin

Conditions Studied

Interventions

  • DRUG Ribavirin
  • DRUG BMS-790052
  • DRUG BMS-650032
  • DRUG BMS-791325

Study Locations (20)

California

  • Southern California Research Center - Coronado
  • Peter J Ruane Md Inc - Los Angeles
  • Va Greater Los Angeles Healthcare System - Los Angeles
  • Research And Education, Inc. - San Diego
  • Precision Research Institute, Llc - San Diego
  • Medical Associates Research Group - San Diego

Florida

  • Orlando Immunology Center - Orlando
  • Miami Research Associates - South Miami

Maryland

  • Mercy Medical Center, Inc. - Baltimore
  • Johns Hopkins University - Lutherville

Oklahoma

  • Options Health Research, Llc - Tulsa
  • Healthcare Research Consultants - Tulsa

Alabama

  • The Kirklin Clinic - Birmingham

Colorado

  • University Of Colorado Denver And Hospital - Aurora

District of Columbia

  • Medstar Georgetown University Hospital - Washington D.C.

Georgia

  • Atlanta Gastroenterology Associates, Llc - Atlanta

Trial Details

FieldValue
Enrollment Target 320 participants
Start Date 2011-11-30
Est. Completion 2015-07-31
Phase Phase 2

Sponsor

Bristol-Myers Squibb

1,025 total trials

What the Registry Record Tells You About NCT01455090

The ClinicalTrials.gov registry entry for NCT01455090 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 320 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 194-participant average among 16 other Chronic Hepatitis C trials with a reported enrollment target (65% higher). The listed sponsor is Bristol-Myers Squibb, which has 1,025 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 4 interventions - of which Ribavirin is the first listed.

NCT01455090 reports 20 study locations spanning 12 distinct geographic areas - top geographies include California, Florida, Maryland.

Frequently Asked Questions

What is clinical trial NCT01455090 about?

NCT01455090 is a clinical study titled "Study to Determine the Effectiveness and Safety of a Three Drug Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) Infected Patients Not Previously Treated With Currently Available Medications". The purpose of this study is to estimate the rate of sustained virologic response (SVR) SVR12, where SVR12 is defined as HCV RNA \< LOQ (detectable or undetectable) 12 weeks post-treatment in Genotype 1 \& Genotype 4 treatment naive patients, and Genotype (GT1) infected patients who are prior null r...

What is the current status of trial NCT01455090?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 320 participants. The study started on 2011-11-30. Estimated completion is 2015-07-31.

What conditions does trial NCT01455090 study?

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

What interventions are being tested in trial NCT01455090?

The interventions under investigation include: Ribavirin (DRUG), BMS-790052 (DRUG), BMS-650032 (DRUG), BMS-791325 (DRUG).

Who is sponsoring clinical trial NCT01455090?

This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01455090 being conducted?

This trial has 20 study locations across Alabama, California, Colorado, District of Columbia, Florida. 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.