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OpenTrials
Completed

NCT Number: NCT01616524

Safety and Efficacy Study of Pegylated Interferon Lambda With and Without Daclatasvir, Compared to Pegylated Interferon Alfa, Plus Ribavirin in Subjects With Hepatitis C Genotype 2 and 3

The purpose of this study is to determine if 24 weeks of treatment with Pegylated Interferon Lambda plus Ribavirin and 12 weeks of treatment with Pegylated Interferon Lambda plus Ribavirin and Daclatasvir will be safe and effective for treatment of hepatitis C compared to 24 weeks of treatment with Pegylated Interferon Alfa-2a plus Ribavirin

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Key information

Conditions

Hepatitis C Virus (HCV) Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis C 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, Autonoma, Buenos Aires, Argentina

Loading trial locations.

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 2 or 3
  • Naïve to prior anti-HCV therapy

Exclusion criteria

  • Infected with HCV other than Genotype 2 or 3
  • Positive Hepatitis B surface antigen (HBsAg), or Human immunodeficiency virus-1 (HIV-1)/HIV-2 antibody at screening
  • Evidence of liver disease other than HCV
  • Active substance abuse
  • Evidence of decompensated cirrhosis

Treatment and study plan

Pegylated interferon lambda (pegIFNλ)

Biological

Syringe, Subcutaneous, 180 μg, Once weekly, 24 weeks

Other names: BMS-914143

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

Biological

Syringe, Subcutaneous, 180 μg, Once weekly, 24 weeks

Other names: Pegasys

Ribavirin

Drug

Tablets, Oral, 400 mg, Twice daily, 24 weeks

Other names: Ribasphere

Daclatasvir

Drug

Tablets, Oral, 60 mg, Once daily, 12 weeks

Other names: BMS-790052

Placebo matching Daclatasvir

Drug

Tablets, Oral, 0 mg, Once daily, 12 weeks

Primary outcomes

  1. Proportion of subjects who achieve Sustained Virologic Response at post-treatment follow-up week 12 (SVR12)

    Time frame: Post-treatment follow-up week 12

Secondary outcomes

  1. Proportion of subjects with Rapid virologic response (RVR) [undetectable Hepatitis C virus (HCV) Ribonucleic acid (RNA)]

    Time frame: On-treatment Week 4

  2. Proportion of subjects with treatment emergent cytopenic abnormalities (anemia as defined by Hb < 10 g/dL, neutropenia as defined by ANC < 750 mm3 or thrombocytopenia as defined by platelets < 50,000 mm3)

    Time frame: Up to week 12 or week 24

    Hb = Hemoglobin ANC = Absolute neutrophil count

  3. Proportion of subjects with on-treatment interferon-associated flu-like symptoms (as defined by pyrexia or chills or pain)

    Time frame: Up to week 12 or week 24

  4. Proportion of subjects with on-treatment musculoskeletal symptoms (as defined by arthralgia or myalgia or back pain)

    Time frame: Up to week 12 or week 24

  5. Proportion of subjects with Sustained Virologic Response at post-treatment follow-up week 24 (SVR24) by treatment group

    Time frame: Post-treatment week 24

  6. Proportion of subjects with on-treatment Serious adverse events (SAEs)

    Time frame: Up to week 12 or week 24

  7. Proportion of subjects with dose reductions

    Time frame: Up to week 12 or week 24

  8. Proportion of subjects who discontinue due to Adverse events (AEs)

    Time frame: Up to week 12 or week 24

  9. Proportion of subjects with SVR12 in subjects with genotype-3 (GT-3) chronic HCV infection

    Time frame: Post-treatment follow-up week 12

  10. Proportion of subjects with on-treatment constitutional symptoms (fatigue or asthenia)

    Time frame: Up to week 12 or week 24

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

A Phase 3, Randomized, Double-Blind, Controlled Study Evaluating the Efficacy and Safety of Peginterferon Lambda-1a, With and Without Daclatasvir, Compared to Peginterferon Alfa-2a, Each in Combination With Ribavirin, in the Treatment of Naïve Genotype 2 and 3 Chronic Hepatitis C Subjects

Acronym: PRINCIPAL

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 11, 2012
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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