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
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)
2 other identifiers
interventional
444
13 countries
78
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2013
78 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 29, 2012
CompletedFirst Posted
Study publicly available on registry
October 31, 2012
CompletedStudy Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedOctober 9, 2015
September 1, 2015
1.7 years
October 29, 2012
September 23, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of subjects with Sustained Virologic Response at post-treatment follow-up Week 12 (SVR12)
Post treatment follow-up Week 12
Secondary Outcomes (13)
Proportion of subjects who achieve SVR12 in treatment-naive subjects
Post treatment follow-up Week 12
Proportion of subjects with rash related dermatologic events
Up to 12 weeks of treatment
Proportion of subjects who develop treatment emergent cytopenic abnormalities
Up to 48 Weeks
Proportion of subjects with on-treatment interferon (IFN) associated flu like/musculoskeletal symptoms
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
Post treatment follow-up Week 24
- +8 more secondary outcomes
Study Arms (2)
Peginterferon Lambda-1a + Ribavirin + Daclatasvir
EXPERIMENTALPeginterferon 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
Peginterferon Alfa-2a + Ribavirin + Telaprevir
EXPERIMENTALPeginterferon 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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (78)
Va Long Beach Healthcare System
Long Beach, California, 90822, United States
Gastrointestinal Specialists Of Georgia Pc
Marietta, Georgia, 30060, United States
Weill Cornell Medical College
New York, New York, 10021, United States
Premier Medical Group Of The Hudson Valley, Pc
Poughkeepsie, New York, 12601, United States
Lehigh Valley Health Network
Allentown, Pennsylvania, 18102, United States
Nashville Medical Research Institute
Nashville, Tennessee, 37205, United States
Texas Clinical Research Institute, Llc
Arlington, Texas, 76012, United States
Medvamc
Houston, Texas, 77030, United States
Local Institution
Buenos Aires, Buenos Aires, 1119, Argentina
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Buenos Aires, Buenos Aires, 1221, Argentina
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Buenos Aires, Buenos Aires, C1181, Argentina
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Capital Federal, Buenos Aires, C1405BCK, Argentina
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Mar del Plata, Buenos Aires, B7600FZN, Argentina
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Prov de Santa Fe, Santa Fe Province, 2000, Argentina
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Clichy, 92118, France
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Grenoble, 38043, France
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Villejuif, 94804, France
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Berlin, 13353, Germany
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Essen, 45122, Germany
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Hamburg, 20099, Germany
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Mannheim, 68167, Germany
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München, 81377, Germany
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Haifa, 34362, Israel
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Tel Aviv, 64239, Israel
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Tel Litwinsky, 52621, Israel
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Zafed, 13110, Israel
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Foggia, 71100, Italy
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Messina, 98125, Italy
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Modena, 41100, Italy
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Pavia, 27100, Italy
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Pisa, 56124, Italy
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Nagoya, Aichi-ken, 4678602, Japan
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Kitakyushu, Fukuoka, 8030816, Japan
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Kitakyushu-shi, Fukuoka, 8028533, Japan
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Gifu, Gifu, 5008727, Japan
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Hiroshima, Hiroshima, 7348511, Japan
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Sapporo, Hokkaido, 0600033, Japan
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Kobe, Hyōgo, 6500047, Japan
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Higashiibaraki-gun, Ibaraki, 3313193, Japan
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Kawasaki-shi, Kanagawa, 2138587, Japan
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Yokohama, Kanagawa, 2320024, Japan
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Yokohama, Kanagawa, 2458575, Japan
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Kumamoto, Kumamoto, 8628655, Japan
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Kyoto, Kyoto, 6028566, Japan
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Kyoto, Kyoto, 6128555, Japan
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Saga, Saga-ken, 8408571, Japan
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Minato-ku, Tokyo, 1058470, Japan
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Musashino-shi, Tokyo, 1808610, Japan
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Sumida-ku, Tokyo, 1308575, Japan
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Tanabe-shi, Wakayama, 6468558, Japan
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Bialystok, 15-540, Poland
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Lodz, 91-347, Poland
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Mysłowice, 41-400, Poland
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Wroclaw, 50-349, Poland
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Moscow, 111123, Russia
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Moscow, 119991, Russia
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Moscow, 119992, Russia
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Moscow, 121170, Russia
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Moscow, 125367, Russia
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Saint Petersburg, 191167, Russia
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Saint Petersburg, 196645, Russia
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Stavropol, 355017, Russia
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Busan, 614-735, South Korea
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Seoul, 110-774, South Korea
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Seoul, 135-720, South Korea
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Seoul, 138-736, South Korea
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Seoul, 143-729, South Korea
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Barcelona, 08916, Spain
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Madrid, 28029, Spain
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Santander, 39008, Spain
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Zaragoza, 50009, Spain
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Kaohsiung, Taiwan, 80756, Taiwan
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Taichung, 404, Taiwan
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Tainan, 704, Taiwan
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Taipei, 100, Taiwan
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Taipei, 112, Taiwan
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Taoyuan District, 333, Taiwan
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London, Greater London, SE5 9RS, United Kingdom
Related Publications (1)
Flisiak R, Kawazoe S, Znoyko O, Assy N, Gadano A, Kao JH, Lee KS, Zwirtes R, Portsmouth S, Dong Y, Xu D, Kumada H, Srinivasan S. Peginterferon Lambda-1a/Ribavirin with Daclatasvir or Peginterferon Alfa-2a/Ribavirin with Telaprevir for Chronic Hepatitis C Genotype 1b. J Interferon Cytokine Res. 2016 Nov;36(11):635-643. doi: 10.1089/jir.2015.0173. Epub 2016 Jun 21.
PMID: 27327078DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 29, 2012
First Posted
October 31, 2012
Study Start
January 1, 2013
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
October 9, 2015
Record last verified: 2015-09