Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED 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

NCT01455090 · View on ClinicalTrials.gov ↗

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

504 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01455090

The ClinicalTrials.gov registry entry for NCT01455090 describes a study currently listed as completed. It is categorized as Phase 2, 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 320 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bristol-Myers Squibb, which has 504 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 4 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: NCT01455090 reports 20 study locations spanning 12 distinct geographic areas — top geographies include California, Florida, Maryland. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01455090?

The interventions under investigation include: Ribavirin (DRUG), BMS-790052 (DRUG), BMS-650032 (DRUG), BMS-791325 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01455090?

This trial is sponsored by Bristol-Myers Squibb, which has 504 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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