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Completed

NCT Number: NCT01795911

Safety Study of Pegylated Interferon Lambda Plus Single or 2 Direct Antiviral Agents With Ribavirin

Substudy C: The purpose of this substudy is to determine whether Lambda combined with Ribavirin and Daclatasvir for 12 weeks is efficacious in treatment naïve subjects with genotype 1b chronic HCV 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–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Alamo Medical Research

San Antonio, Texas, 78215, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Chronic Hepatitis C, Genotype 1
  • HCV RNA >100,000 IU/mL at screening;
  • Seronegative for Human immunodeficiency virus (HIV) and Hepatitis B surface antigen (HBsAg);
  • Liver biopsy within prior 2 years; subjects with compensated cirrhosis can enroll and will be capped at approximately 10%

Exclusion criteria

  • Any evidence of liver disease other than HCV;
  • Co-infection with HIV;
  • Diagnosed or suspected hepatocellular carcinoma;
  • Medical history or laboratory value abnormalities that would prohibit the use of Pegylated Interferon Alpha-2a or Ribavirin

Treatment and study plan

Pegylated Interferon Lambda

Biological

Other names: BMS-914143

Ribasphere

Drug

Other names: Ribavirin

Daclatasvir

Drug

Other names: BMS-790052

Primary outcomes

  1. Antiviral activity, as determined by the proportion of non-cirrhotic HCV GT-1b subjects with 12-week sustained virologic response (SVR12), defined as HCV RNA < LLOQ target detected or not detected

    Time frame: Post-treatment Week 12

    HCV = Hepatitis C virus; GT = Geno Type; RNA = Ribonucleic acid; LLOQ = Lower limit of quantitation

Secondary outcomes

  1. Proportion of non-cirrhotic HCV GT-1b subjects with eRVR, defined as HCV RNA < LLOQ target not detected

    Time frame: At Week 4 and Week 12

    eRVR = Extended rapid virologic response

  2. Proportion of non-cirrhotic HCV GT-1b subjects with treatment-emergent cytopenic abnormalities (anemia as defined by Hb < 10 g/dL, and/or neutropenia as defined by ANC < 750 mm3, and/or thrombocytopenia as defined by platelets < 50,000 mm3) on treatment

    Time frame: On-treatment Weeks 1, 2, 4, 8, and 12

    Hb = Hemoglobin; ANC = Absolute neutrophil count

  3. Proportion of non-cirrhotic HCV GT-1b subjects with on-treatment (maximum of 12 weeks) interferon-associated flu-like symptoms (pyrexia or chills or pain)

    Time frame: On-treatment Weeks 1, 2, 4, 8, and 12

  4. Proportion of non-cirrhotic HCV GT-1b subjects with on-treatment (maximum of 12 weeks) interferon-associated musculoskeletal symptoms (arthralgia or myalgia or back pain)

    Time frame: On-treatment Weeks 1, 2, 4, 8, and 12

  5. Proportion of non-cirrhotic HCV GT-1b subjects with SVR24, defined as HCV RNA < LLOQ target detected or not detected

    Time frame: Post-treatment follow-up Week 24

  6. Frequency of deaths among non-cirrhotic HCV GT-1b subjects through the end of follow-up (maximum of 60 weeks)

    Time frame: On-treatment Weeks 1, 2, 4, 8, and 12 and post-treatment weeks 4, 12, 24, 36 and 48

  7. Frequency of Serious adverse events (SAEs) among non-cirrhotic HCV GT-1b subjects through the end of follow-up (maximum of 60 weeks)

    Time frame: On-treatment Weeks 1, 2, 4, 8, and 12 and post-treatment weeks 4, 12, 24, 36 and 48

  8. Frequency of drug related Adverse events (AEs) among non-cirrhotic HCV GT-1b subjects through the end of treatment (maximum of 12 weeks)

    Time frame: On-treatment Weeks 1, 2, 4, 8, and 12

  9. Frequency of dose reductions and discontinuations due to AEs among non-cirrhotic HCV GT-1b subjects through the end of treatment (maximum of 12 weeks)

    Time frame: On-treatment Weeks 1, 2, 4, 8, and 12

  10. Frequency of treatment emergent laboratory abnormalities among non-cirrhotic HCV GT-1b subjects through the end of treatment (maximum of 12 weeks)

    Time frame: On-treatment Weeks 1, 2, 4, 8, and 12

  11. Proportion of non-cirrhotic HCV GT-1b subjects with interferon-associated constitutional symptoms (fatigue or asthenia) through the end of treatment (maximum of 12 weeks)

    Time frame: On-treatment Weeks 1, 2, 4, 8, and 12

  12. Proportion of non-cirrhotic HCV GT-1b subjects with interferon-associated neurologic symptoms (headache or dizziness) through the end of treatment (maximum of 12 weeks)

    Time frame: On-treatment Weeks 1, 2, 4, 8, and 12

  13. Proportion of non-cirrhotic HCV GT-1b subjects with psychiatric symptoms (depression or irritability or insomnia) through the end of treatment (maximum of 12 weeks)

    Time frame: On-treatment Weeks 1, 2, 4, 8, and 12

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Phase 2B, Randomized Study to Evaluate the Safety and Efficacy of Pegylated Interferon Lambda (BMS-914143) Administered With Ribavirin Plus a Single Direct Antiviral Agent (BMS-790052 or BMS-650032) Versus Pegasys Administered With Ribavirin (Part A) and of Pegylated Interferon Lambda (BMS-914143) Administered With or Without Ribavirin Plus 2 Direct Antiviral Agents (BMS-790052 and BMS-650032) (Part B) in Chronic Hepatitis C Genotype-1 Treatment naïve Subjects

Acronym: D-LITE

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 21, 2013
Registry last updated
Oct 9, 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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