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Completed

NCT Number: NCT01979939

UNITY 1: A Study of an Investigational Treatment Regimen of Daclatasvir (DCV) + Asunaprevir (ASV) + BMS-791325 in a Fixed Dose Combination (the DCV 3DAA (Direct Acting Antiviral) Regimen) for 12 Weeks for the Treatment of Chronic Hepatitis C Virus (HCV) Genotype 1 Infection in Non-cirrhotic Subjects

To demonstrate the effectiveness of DCV 3DAA fixed dose regimen in treatment naive and treatment experienced non-cirrhotic subjects

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Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Local Institution, Darlinghurst, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion criteria

  • Subjects chronically infected with HCV genotype 1
  • HCV RNA ≥ 10,000 IU/mL at screening
  • Treatment-naïve subjects with no previous exposure to an interferon formulation (ie, IFNα, pegIFNα), RBV, or HCV DAA (protease, polymerase inhibitor, etc.)
  • Treatment-experienced subjects are eligible

Exclusion criteria

  • Evidence of cirrhosis
  • Liver or any other organ transplant
  • Current or known history of cancer within 5 years prior to enrollment
  • Documented or suspected HCC
  • Evidence of decompensated liver

Treatment and study plan

DCV/ASV/BMS-791325

Drug

Primary outcomes

  1. Proportion of treated subjects in the naive cohort with sustained virologic response (SVR) 12

    Time frame: Post-Treatment Week 12

    SVR12 is defined as HCV ribonucleic acid (RNA) < limit of quantitation (LOQ) target detected or target not detected (LOQ TD/TND) at post treatment Week 12

Secondary outcomes

  1. Proportion of subjects in the experienced cohort with SVR12

    Time frame: Follow up Week 12

  2. Proportion of subjects in each cohort who achieve HCV RNA <LOQ TD/TND

    Time frame: On-treatment Weeks: 1, 2, 4, 6, 8, and 12; post treatment Weeks 4 (SVR4), 8 (SVR8) and 24 (SVR24)

  3. Proportion of subjects in each cohort who achieve HCV RNA <LOQ TND

    Time frame: On-treatment Weeks: 1, 2, 4, 6, 8, and 12; post treatment weeks 4, 8, 12 and 24

  4. Safety measured by frequency of serious AEs (SAEs) and discontinuations due to adverse events (AEs) through the end of treatment in each cohort

    Time frame: Up to post treatment week 4 (±7 days)

  5. Proportion of anemia defined as Hg <10 g/dL on-treatment and Hg ≥10 g/dL at baseline , in each cohort

    Time frame: Up to post treatment week 4 (±7 days)

  6. Rates of selected grade 3-4 lab abnormalities (hematologic and liver function) in each cohort

    Time frame: Up to post treatment week 4 (±7 days)

  7. Proportion of subjects in each cohort achieving SVR12 associated with HCV geno subtype 1a vs 1b

    Time frame: Post treatment week 12

  8. Proportion of subjects in each cohort achieving SVR12 associated with IL28B rs12979860 single nucleotide polymorphism (SNP) status (CC genotype or non-CC genotype)

    Time frame: Post treatment week 12

  9. Proportion of subjects in each cohort achieving SVR12 associated with stage of liver fibrosis

    Time frame: Post treatment week 12

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Phase 3 Evaluation of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination in Non-cirrhotic Subjects With Genotype 1 Chronic Hepatitis C

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Nov 8, 2013
Registry last updated
Nov 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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