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NCT01973049 · ClinicalTrials.gov registry record · Phase 3

UNITY 2: A Study of an Investigational Treatment Regimen of DCV+ASV+BMS-791325 in a Fixed Dose Combination (the DCV 3DAA (Direct Acting Antiviral) Regimen) With or Without RBV for 12 Weeks for the Treatment of Chronic Hepatitis C Virus(HCV)Genotype 1 Infection in Subjects With Compensated Cirrhosis

A Phase 3 study, sponsored by Bristol-Myers Squibb.

Completed
Registry status
Phase 3
Development phase
202
Enrollment target

NCT01973049 is a Phase 3 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 202 participants.

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The verdict

NCT01973049, a Phase 3 study, has completed, sponsored by Bristol-Myers Squibb.

COMPLETED
Registry status
Phase 3
Development phase
202 participants
Enrollment target

Study Summary

To demonstrate the effectiveness of DCV 3DAA fixed dose combination with or without Ribavirin in treatment naive cirrhotic subjects.

Interventions

  • DRUG Ribavirin
  • DRUG Daclatasvir
  • DRUG BMS-791325
  • DRUG Asunaprevir
  • DRUG Placebo matching Ribavirin

Trial Details

FieldValue
Enrollment Target 202 participants
Start Date 2013-12
Est. Completion 2014-11
Phase Phase 3

Sponsor

Bristol-Myers Squibb

1,025 total trials

What the Registry Record Tells You About NCT01973049

The ClinicalTrials.gov registry entry for NCT01973049 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 202 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bristol-Myers Squibb, which has 1,025 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which Ribavirin is the first listed.

NCT01973049 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01973049 about?

NCT01973049 is a clinical study titled "UNITY 2: A Study of an Investigational Treatment Regimen of DCV+ASV+BMS-791325 in a Fixed Dose Combination (the DCV 3DAA (Direct Acting Antiviral) Regimen) With or Without RBV for 12 Weeks for the Treatment of Chronic Hepatitis C Virus(HCV)Genotype 1 Infection in Subjects With Compensated Cirrhosis". To demonstrate the effectiveness of DCV 3DAA fixed dose combination with or without Ribavirin in treatment naive cirrhotic subjects.

What is the current status of trial NCT01973049?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 202 participants. The study started on 2013-12. Estimated completion is 2014-11.

What interventions are being tested in trial NCT01973049?

The interventions under investigation include: Ribavirin (DRUG), Daclatasvir (DRUG), BMS-791325 (DRUG), Asunaprevir (DRUG), Placebo matching Ribavirin (DRUG).

Who is sponsoring clinical trial NCT01973049?

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

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

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.