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)
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| ClinicalTrials.gov Identifier: NCT01718158 |
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Recruitment Status :
Completed
First Posted : October 31, 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 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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Hepatitis C | Biological: Peginterferon Lambda-1a Biological: Peginterferon Alfa-2a Drug: Ribavirin Drug: Daclatasvir Drug: Telaprevir | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 444 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (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) |
| Study Start Date : | January 2013 |
| Actual Primary Completion Date : | October 2014 |
| Actual Study Completion Date : | October 2014 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: Peginterferon Lambda-1a + Ribavirin + Daclatasvir
Peginterferon Lambda-1a 180 µg solution for subcutaneous injection, once a week for 24 Weeks Ribavirin 200 mg tablets [1000-1200 mg total daily dose: subjects should take either 400 mg (2 tablets for subjects < 75 kg) or 600 mg (3 tablets for subjects ≥ 75 kg) in the morning with food and 600 mg (3 tablets) in the evening with food] by mouth, twice daily, 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 |
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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 200 mg tablets [1000-1200 mg total daily dose: subjects should take either 400 mg (2 tablets for subjects < 75 kg) or 600 mg (3 tablets for subjects ≥ 75 kg) in the morning with food and 600 mg (3 tablets) in the evening with food] by mouth, twice daily, for 24 to 48 weeks depending on response Telaprevir 375 mg tablets [2250 mg total daily dose: subjects should take 750 mg (two 375 mg tablets) orally three times a day, approximately 7-9 hours apart) for 12 weeks |
Biological: Peginterferon Alfa-2a
Other Name: Pegasys® Drug: Ribavirin Other Name: Copegus® Drug: Telaprevir Other Name: Incivek® |
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 ]
Secondary Outcome Measures :
- Proportion of subjects who achieve SVR12 in treatment-naive subjects [ Time Frame: Post treatment follow-up Week 12 ]
- Proportion of subjects with rash related dermatologic events [ Time Frame: Up to 12 weeks of treatment ]
- Proportion of subjects who develop treatment emergent cytopenic abnormalities [ Time Frame: Up to 48 Weeks ]Treatment emergent cytopenic abnormalities [anemia as defined by Hemoglobin (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 ]
- 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 ]SVR24 = Sustained virologic response at post treatment follow-up Week 24
- Proportion of subjects with adverse events (AEs), Serious adverse events (SAEs), dose reductions, and discontinuations due to AEs through end of follow-up [ Time Frame: Maximum of 72 weeks ]
- Proportion of subjects who achieve SVR12 with a 24-week treatment regimen [ Time Frame: Post treatment follow-up Week 12 ]
- Proportion of subjects who achieve Extended rapid virologic response (eRVR) (HCV RNA < LLOQ target not detected at Weeks 4 and 12 of treatment) [ Time Frame: Weeks 4 and 12 of treatment ]
- Patient Health Questionnaire-9 (PHQ-9) score through end of follow-up [ Time Frame: Maximum of 72 weeks ]
- Proportion of subjects with treatment emergent laboratory abnormalities by toxicity grade through End of treatment (EOT) [ Time Frame: Maximum of 72 weeks ]
- Proportion of subjects with the following on-treatment interferon-associated neuropsychiatric symptoms through EOT [ Time Frame: Maximum of 48 weeks ]Psychiatric symptoms (depression, irritability or insomnia)
- Association of Single nucleotide polymorphism (SNPs) in Interleukin 28B (IL28B) (including rs12979860) or equilibrative nucleoside transporter 1 (ENT1) with clinical responses [ Time Frame: Post-treatment follow-up Week 12 ]For each SNP in each candidate gene, allele and genotype frequencies will be summarized by treatment regimen
- Resistant variants associated with virologic failure through end of follow-up [ Time Frame: Maximum of 72 weeks ]
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
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
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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)
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): NCT01718158
Locations
Show 78 study locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT01718158 |
| Other Study ID Numbers: |
AI452-021 2011-005409-65 ( EudraCT Number ) |
| First Posted: | October 31, 2012 Key Record Dates |
| Last Update Posted: | October 9, 2015 |
| Last Verified: | September 2015 |
Additional relevant MeSH terms:
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Hepatitis C Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Infections RNA Virus Infections Blood-Borne Infections |
Communicable Diseases Flaviviridae Infections Ribavirin Peginterferon alfa-2a Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents |