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 (PRINCIPAL)
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| ClinicalTrials.gov Identifier: NCT01616524 |
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Recruitment Status :
Completed
First Posted : June 11, 2012
Last Update Posted : October 9, 2015
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Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
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Brief Summary:
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
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hepatitis C Virus (HCV) | Biological: Pegylated interferon lambda (pegIFNλ) Biological: Pegylated interferon alfa-2a (pegIFNα-2a) Drug: Ribavirin Drug: Daclatasvir Drug: Placebo matching Daclatasvir | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 880 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official 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 |
| Study Start Date : | July 2012 |
| Actual Primary Completion Date : | June 2014 |
| Actual Study Completion Date : | September 2014 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
| Experimental: Arm 1: pegIFNλ + Ribavirin + Placebo matching Daclatasvir |
Biological: Pegylated interferon lambda (pegIFNλ)
Syringe, Subcutaneous, 180 μg, Once weekly, 24 weeks
Other Name: BMS-914143 Drug: Ribavirin Tablets, Oral, 400 mg, Twice daily, 24 weeks
Other Name: Ribasphere Drug: Placebo matching Daclatasvir Tablets, Oral, 0 mg, Once daily, 12 weeks |
| Experimental: Arm 2: pegIFNλ + Ribavirin + Daclatasvir |
Biological: Pegylated interferon lambda (pegIFNλ)
Syringe, Subcutaneous, 180 μg, Once weekly, 12 weeks
Other Name: BMS-914143 Drug: Ribavirin Tablets, Oral, 400 mg, Twice daily, 12 weeks
Other Name: Ribasphere Drug: Daclatasvir Tablets, Oral, 60 mg, Once daily, 12 weeks
Other Name: BMS-790052 |
| Experimental: Arm 3: pegIFNα-2a + Ribavirin + Placebo matching Daclatasvir |
Biological: Pegylated interferon alfa-2a (pegIFNα-2a)
Syringe, Subcutaneous, 180 μg, Once weekly, 24 weeks
Other Name: Pegasys Drug: Ribavirin Tablets, Oral, 400 mg, Twice daily, 24 weeks
Other Name: Ribasphere Drug: Placebo matching Daclatasvir Tablets, Oral, 0 mg, Once daily, 12 weeks |
Primary Outcome Measures :
- 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 Outcome Measures :
- Proportion of subjects with Rapid virologic response (RVR) [undetectable Hepatitis C virus (HCV) Ribonucleic acid (RNA)] [ Time Frame: On-treatment Week 4 ]
- 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
- 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 ]
- 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 ]
- Proportion of subjects with Sustained Virologic Response at post-treatment follow-up week 24 (SVR24) by treatment group [ Time Frame: Post-treatment week 24 ]
- Proportion of subjects with on-treatment Serious adverse events (SAEs) [ Time Frame: Up to week 12 or week 24 ]
- Proportion of subjects with dose reductions [ Time Frame: Up to week 12 or week 24 ]
- Proportion of subjects who discontinue due to Adverse events (AEs) [ Time Frame: Up to week 12 or week 24 ]
- Proportion of subjects with SVR12 in subjects with genotype-3 (GT-3) chronic HCV infection [ Time Frame: Post-treatment follow-up week 12 ]
- Proportion of subjects with on-treatment constitutional symptoms (fatigue or asthenia) [ Time Frame: Up to week 12 or week 24 ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01616524
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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Additional Information:
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT01616524 History of Changes |
| Other Study ID Numbers: |
AI452-017 2011-004885-14 ( EudraCT Number ) |
| First Posted: | June 11, 2012 Key Record Dates |
| Last Update Posted: | October 9, 2015 |
| Last Verified: | September 2015 |
Additional relevant MeSH terms:
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Hepatitis A Hepatitis C Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Interferons |
Ribavirin Interferon-alpha Interferon alpha-2 Peginterferon alfa-2a Antineoplastic Agents Antiviral Agents Anti-Infective Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Immunologic Factors Physiological Effects of Drugs |