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OpenTrials
Completed

NCT Number: NCT01309932

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

The purpose of this study is to determine if combination therapy with Pegylated Interferon Lambda (BMS-914143) plus Ribavirin (RBV) with a single direct antiviral agent (BMS-790052 or BMS-650032) for 24 weeks is effective and safe for treatment of Chronic Hepatitis C (CHC) compared to current standard therapy with Pegylated Interferon Alpha-2a plus RBV for 48 weeks.

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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

Local Institution, Adelaide, South Australia, Australia

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About this study

Study Classification: Pharmacokinetics/ Pharmacodynamics

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

  • 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 (pegIFNλ)

Biological

Solution, Subcutaneous, 180 μg/mL, Once weekly, 24 or 48 weeks depending on response

Other names: BMS-914143

BMS-790052 (NS5A Inhibitor)

Drug

Tablets, Oral, 60 mg, Once daily, 24 weeks

Other names: BMS-790052

ribavirin (RBV)

Drug

Tablets, Oral, 1000 or 1200 mg based on weight, Twice daily, 48 weeks

Other names: Ribasphere

BMS-650032 (NS3 Protease Inhibitor)

Drug

Tablets, Oral, 200 mg, Twice daily, 24 weeks

Other names: BMS-650032

Pegylated interferon alfa-2a (pegIFNα-2a)

Biological

Solution, Subcutaneous, 180 μg/mL, Once weekly, 48 weeks

Other names: Pegasys®

Placebo (PBO) for BMS-650032 (Placebo for NS3 Protease Inhibitor)

Drug

Tablets, Oral, 0 mg, Twice daily, 24 weeks

Other names: Placebo for BMS-650032

Placebo (PBO) for BMS-790052 (Placebo for NS5A Inhibitor)

Drug

Tablets, Oral, 0 mg, Once daily, 24 weeks

Other names: Placebo for BMS-790052

Placebo for Ribavirin (RBV)

Drug

Tablets, Oral, 0 mg, Twice daily, 24 weeks

Other names: Placebo for Ribasphere

Primary outcomes

  1. Safety and tolerability (as measured by the frequency of serious adverse events (SAEs), dose reductions and discontinuations due to adverse events (AEs)

    Time frame: Up to end of treatment ( maximum of 48 weeks) plus 30 days

  2. Antiviral activity as determined by the proportion of Hepatitis C virus (HCV) genotype 1 subjects with 24-week sustained virologic response (SVR24)

    Time frame: At end of treatment (maximum of 48 weeks)

  3. Antiviral activity as determined by the proportion of Hepatitis C virus (HCV) genotype 1 subjects with 24-week sustained virologic response (SVR24)

    Time frame: Post-treatment Week 24

Secondary outcomes

  1. Proportion of HCV genotype 1 subjects with Protocol definition of virologic response (PDR) for Part A and Part B

    Time frame: Weeks 4, Weeks 12 and post-treatment Weeks 24

    • Part A PDR is defined as HCV RNA at Week 4 < LLOQ and Week 12 undetectable
    • Part B PDR is defined as HCV RNA at Week 2 ≥ 2 log10 decrease (or < Lower limit of quantitation (LLOQ) if baseline HCV RNA < 2400 IU/mL), Week 4 < LLOQ and Week 12 undetectable

  2. Proportion of subjects with either a 2-log or greater decrease in Hepatitis C virus (HCV) Ribonucleic acid (RNA) levels from baseline or undetectable levels of HCV RNA

    Time frame: Weeks 2, Weeks 4 and Weeks 12

  3. Proportion of subjects with viral breakthrough, defined as confirmed > 1 log10 increase in HCV RNA over nadir or confirmed HCV RNA ≥ Lower limit of quantitation (LLOQ) after confirmed undetectable HCV RNA while on treatment

    Time frame: Post-treatment Week 48

  4. Proportion of subjects with undetectable HCV RNA at the end of treatment that develop detectable levels of HCV RNA in the post-treatment follow-up period

    Time frame: Post-treatment Week 48

  5. Serum HCV Ribonucleic acid (RNA) levels over time

    Time frame: Days 1, 3, Weeks 1, 2, 4, 6, 8, 12, 16, 20, and end of treatment (Week 16, 24 or 48 depending on treatment assignment)

  6. Proportion of subjects with undetectable HCV RNA over time

    Time frame: Days 1, 3, Weeks 1, 2, 4, 6, 8, 12, 16, 20, and end of treatment (Week 16, 24 or 48 depending on treatment assignment)

  7. Time to viral clearance, defined as an absence of detectable HCV RNA

    Time frame: Day 1, 3, Week 1, 2, 4, 6, 8, 12, 24, 36, end of treatment (Week 48), Post-Treatment at Week 4, 12, 24, 36, 48, and 56

  8. Serum levels of pegIFNλ and pegIFNα-2a and plasma levels of BMS-790052 and BMS-650032: In PK sub-study group Maximum observed serum/plasma concentration (Cmax)

    Time frame: Cmax will be determined at Dose 5 (Study Visit Week 4: 0 - 12 h for BMS-650032, 0 - 24 h for BMS-790052, and 0 - 168 h for pegIFNλ and pegIFNα-2a)

  9. Serum levels of pegIFNλ and pegIFNα-2a and plasma levels of BMS-790052 and BMS-650032: In PK sub-study group Time to maximum concentration (Tmax)

    Time frame: Tmax will be determined at Dose 5 (Study Visit Week 4: 0 - 12 h for BMS-650032, 0 - 24 h for BMS-790052, and 0 - 168 h for pegIFNλ and pegIFNα-2a)

  10. Serum levels of pegIFNλ and pegIFNα-2a and plasma levels of BMS-790052 and BMS-650032: In PK sub-study group Minimal observed serum/plasma concentration (Cmin)

    Time frame: Cmin will be determined at Dose 5 (Study Visit Week 4: 0 - 12 h for BMS-650032, 0 - 24 h for BMS-790052, and 0 - 168 h for pegIFNλ and pegIFNα-2a)

  11. Serum levels of pegIFNλ and pegIFNα-2a and plasma levels of BMS-790052 and BMS-650032: In PK sub-study group Area under the serum/plasma concentration-time curve during one dose interval AUC(TAU)

    Time frame: AUC(TAU) will be determined at Dose 5 (Study Visit Week 4: 0 - 12 h for BMS-650032, 0 - 24 h for BMS-790052, and 0 - 168 h for pegIFNλ and pegIFNα-2a)

  12. Serum levels of pegIFNλ and pegIFNα-2a and plasma levels of BMS-790052 and BMS-650032: In all subjects, trough concentrations will be assessed (Ctrough)

    Time frame: Troughs at baseline (week 0), weeks 2, 4, 8, 12, 16, and 24

  13. Proportion of subjects with 12-week sustained virologic response (SVR12), defined as undetectable HCV RNA

    Time frame: At end of treatment (maximum of 48 weeks) and follow-up Week 12

  14. Proportion of subjects with 4-week sustained virologic response (SVR4), defined as undetectable HCV RNA

    Time frame: At end of treatment (maximum of 48 weeks) and follow-up Week 4

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
2011
Primary completion
2014
Study completion
2014
First posted
Mar 7, 2011
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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