Efficacy and Safety Evaluation of a Regimen Consisting of Peginterferon Lambda-1a + Ribavirin + Daclatasvir (Lambda + RBV + DCV) in HCV Genotype 1b Treatment naïve Patients or Prior Relapsers to Peginterferon Alfa + Ribavirin (Alfa + RBV) Therapy (STRUCTURE)
This study is currently recruiting participants.
Verified April 2013 by Bristol-Myers Squibb
Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01718158
First received: October 29, 2012
Last updated: April 4, 2013
Last verified: April 2013
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Purpose
The purpose of this study is to determine if treatment with Pegylated Interferon Lambda-1a, given in combination with Ribavirin and Daclatasvir for 24 weeks, is as safe and effective as the standard treatment with Pegylated Interferon Alfa-2a + Ribavirin + Telaprevir in subjects who are infected with Chronic Hepatitis C virus genotype 1b and have never received any prior anti-HCV treatment, or who have relapsed after an initial, successful treatment with Pegylated Interferon Alfa + Ribavirin
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis C |
Biological: Peginterferon Lambda-1a Biological: Peginterferon Alfa-2a Drug: Ribavirin Drug: Daclatasvir Drug: Telaprevir |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 3 Evaluation of Daclatasvir in Combination With Peginterferon Lambda-1a and Ribavirin (RBV) or Telaprevir in Combination With Peginterferon Alfa-2a and RBV in Patients With Chronic Hepatitis C Genotype 1b Who Are Treatment naïve or Prior Relapsers to Alfa/RBV Therapy (the STRUCTURE Study) |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- Proportion of subjects with Sustained Virologic Response at post-treatment follow-up Week 12 (SVR12) [ Time Frame: Post treatment follow-up Week 12 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Proportion of subjects who achieve SVR12 in treatment-naive subjects [ Time Frame: Post treatment follow-up Week 12 ] [ Designated as safety issue: No ]
- Proportion of subjects with rash related dermatologic events [ Time Frame: At 12 weeks of treatment ] [ Designated as safety issue: No ]
- Proportion of subjects who develop treatment emergent cytopenic abnormalities [ Time Frame: Up to 48 Weeks ] [ Designated as safety issue: No ]Treatment emergent cytopenic abnormalities (anemia as defined by Hb < 10 g/dL, and/or neutropenia as defined by absolute neutrophil count (ANC) < 750/mm3, and or thrombocytopenia as defined by platelets < 50,000/mm3)
- Proportion of subjects with on-treatment interferon (IFN) associated flu like/musculoskeletal symptoms [ Time Frame: Up to 48 Weeks ] [ Designated as safety issue: No ]
- Proportion of subjects who achieve SVR24 [Hepatitis C virus (HCV) Ribonucleic acid (RNA) < Lower limit of quantitation (LLOQ)] at post-treatment follow-up Week 24 [ Time Frame: Post treatment follow-up Week 24 ] [ Designated as safety issue: No ]SVR24 = Sustained virologic response at post treatment follow-up Week 24
| Estimated Enrollment: | 450 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | February 2015 |
| Estimated Primary Completion Date: | November 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Peginterferon Lambda-1a + Ribavirin + Daclatasvir
Peginterferon Lambda-1a 180 µg solution for subcutaneous injection, once a week for 24 Weeks Ribavirin 1000-1200 mg tablets by mouth, once a day for 24 weeks Daclatasvir 60 mg tablets by mouth, once a day for 12 weeks |
Biological: Peginterferon Lambda-1a
Other Name: BMS-914143
Drug: Ribavirin
Other Name: Copegus®
Drug: Daclatasvir
Other Name: BMS-790052
|
|
Experimental: Peginterferon Alfa-2a + Ribavirin + Telaprevir
Peginterferon Alfa-2a 180 µg solution for subcutaneous injection, once a week for 24 to 48 weeks depending on response Ribavirin 1000-1200 mg tablets by mouth, once a day for 24 to 48 weeks depending on response Telaprevir 2250 mg tablets by mouth, once a day for 12 weeks |
Biological: Peginterferon Alfa-2a
Other Name: Pegasys®
Drug: Ribavirin
Other Name: Copegus®
Drug: Telaprevir
Other Name: Incivek®
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients chronically infected with HCV Genotype-1b
- Naïve to prior treatment or documented evidence of relapse after completion of the prescribed duration of treatment (duration may be 24 or 48 weeks, to be determined based upon local guidelines)
- HCV RNA viral load ≥100,000 IU/mL at screening
- Patients with compensated cirrhosis are permitted
Exclusion Criteria:
- Infection with Hepatitis C virus (HCV) other than Genotype-1b
- Positive Hepatitis B surface antigen (HBsAg) or Human immunodeficiency virus (HIV)-1/HIV-2 antibody test at screening
- Evidence of chronic liver disease caused by diseases other than chronic HCV infection
- Current evidence of or history of variceal bleeding, hepatic encephalopathy, or ascites requiring diuretics or paracentesis or evidence of any of these findings on physical examination performed at screening
- Current or known history of cancer (except adequately treated in situ carcinoma of the cervix, or basal or squamous cell carcinoma of the skin) within 5 years prior to screening
- Current evidence or known history of decompensated cirrhosis based on radiologic criteria or biopsy results and clinical criteria
Laboratory values:
- Hemoglobin <12.0 g/dL (males) or <11.0 g/dL (females)
- Platelets <90,000/mm3
- Total serum bilirubin ≥2 mg/dL (unless due to Gilbert's disease)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01718158
Show 36 Study Locations
Contacts
| Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email: | Clinical.Trials@bms.com | |
| Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time. |
Show 36 Study LocationsSponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
No publications provided
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT01718158 History of Changes |
| Other Study ID Numbers: | AI452-021, 2011‐005409‐65 |
| Study First Received: | October 29, 2012 |
| Last Updated: | April 4, 2013 |
| Health Authority: | United States: Institutional Review Board United States: Food and Drug Administration Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Germany: Ministry of Health Israel: Israeli Health Ministry Pharmaceutical Administration Israel: Ministry of Health Italy: Ministry of Health Italy: National Bioethics Committee Italy: National Institute of Health Italy: National Monitoring Centre for Clinical Trials - Ministry of Health Italy: The Italian Medicines Agency Japan: Pharmaceuticals and Medical Devices Agency Japan: Ministry of Health, Labor and Welfare Korea: Food and Drug Administration Poland: National Institute of Medicines Poland: Ministry of Health Poland: Ministry of Science and Higher Education Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Russia: FSI Scientific Center of Expertise of Medical Application Russia: Ethics Committee Russia: Ministry of Health of the Russian Federation Spain: Spanish Agency of Medicines Taiwan: Department of Health Taiwan: National Bureau of Controlled Drugs United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis C Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections |
Ribavirin Peginterferon alfa-2a Interferon-alpha Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antimetabolites Molecular Mechanisms of Pharmacological Action Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 23, 2013