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Completed

NCT Number: NCT02496078

A Phase 3 Evaluation of Daclatasvir and Asunaprevir in Treatment-naive Subjects With Chronic Hepatitis C Genotype 1b Infection

The purpose of this study is to determine whether a regimen consisting of daclatasvir and asunaprevir is effective in treatment-naive patients with chronic hepatitis genotype 1b infection.

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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, Beijing, Beijing Municipality, China

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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

  • Patients chronically infected with HCV Genotype 1b
  • No previous exposure to any interferon formulation, Ribavirin (RBV), and HCV direct acting antiviral agent
  • HCV RNA viral load ≥ 10,000 IU/mL at screening
  • Seronegative for HIV and HBsAg
  • BMI of 18-35 kg/m2, inclusive
  • Patients with compensated cirrhosis are permitted

Exclusion criteria

  • Infection with HCV other than genotype (GT) -1b
  • Evidence of decompensated liver disease including, but not limited to, a history or presence of ascites, bleeding varices, or hepatic encephalopathy
  • Evidence of a medical condition contributing to chronic liver disease other than HCV
  • Diagnosed or suspected hepatocellular carcinoma or other malignancies
  • Uncontrolled diabetes or hypertension
  • History of moderate to severe depression. Well-controlled mild depression is allowed
  • Confirmed alanine aminotransferase (ALT) ≥ 5x Upper Limit of Normal (ULN)
  • Confirmed platelet count < 50,000 cells/mm3
  • Confirmed hemoglobin < 8.5 g/dL

Treatment and study plan

Daclatasvir

Drug

Daclatasvir tablet 60mg

Asunaprevir

Drug

Asunaprevir soft capsule 100 mg

Primary outcomes

  1. Proportion of treated subjects randomized to Active Dual therapy with Sustained Virologic Response (SVR12)

    Time frame: Post-treatment Week 12

    HCV RNA < Lower limit of quantitation (LLOQ) target detected (TD) or target not detected (TND) at follow-up Week 12

Secondary outcomes

  1. Proportion of subjects with anemia on active Dual therapy

    Time frame: Post-treatment Week 12

  2. Proportion of subjects with neutropenia on active Dual therapy

    Time frame: Post-treatment Week 12

  3. Proportion of subjects with thrombocytopenia on active Dual therapy

    Time frame: Post-treatment Week 12

  4. On treatment safety, as measured by frequency of serious adverse events (SAEs) and discontinuations due to adverse events (AEs)

    Time frame: Post-treatment week 12

  5. Differences in rates of selected Grade 3-4 laboratory abnormalities for hematology between treatments (DCV + Asunaprevir (ASV) vs PBO)

    Time frame: first 12 weeks on treatment

  6. Differences in rates of selected Grade 3-4 laboratory abnormalities for liver function between treatments (DCV + Asunaprevir (ASV) vs PBO)

    Time frame: first 12 weeks on treatment

  7. Proportion of subjects with SVR12 by the rs12979860 single nucleotide polymorphism (SNP) in the interleukin (IL) -28B gene for each cohort

    Time frame: Post-treatment visit week 12

  8. Proportion of subjects with hepatitis C virus (HCV) RNA < LLOQ-TD/TND in each arm at various intervals after the initiation of active Dual therapy

    Time frame: post-treatment visit Week 24

  9. Proportion of subjects who achieve HCV RNA < LLOQ-TND at each arm at various intervals after the initiation of active Dual therapy

    Time frame: post-treatment visit Week 24

  10. Proportion of treated subjects with SVR12 for subjects randomized to placebo

    Time frame: Post-treatment visit week 12

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Jul 14, 2015
Registry last updated
Apr 19, 2017

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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