Back to resultsEfficacy 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)
Primary Purpose
Hepatitis C
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Peginterferon Lambda-1a
Peginterferon Alfa-2a
Ribavirin
Daclatasvir
Telaprevir
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis C
Eligibility 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)
Sites / Locations
- Va Long Beach Healthcare System
- Gastrointestinal Specialists Of Georgia Pc
- Weill Cornell Medical College
- Premier Medical Group Of The Hudson Valley, Pc
- Lehigh Valley Health Network
- Nashville Medical Research Institute
- Texas Clinical Research Institute, Llc
- Medvamc
- Local Institution
- Local Institution
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- Local Institution
- Local Institution
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Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Peginterferon Lambda-1a + Ribavirin + Daclatasvir
Peginterferon Alfa-2a + Ribavirin + Telaprevir
Arm Description
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
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
Outcomes
Primary Outcome Measures
Proportion of subjects with Sustained Virologic Response at post-treatment follow-up Week 12 (SVR12)
Secondary Outcome Measures
Proportion of subjects who achieve SVR12 in treatment-naive subjects
Proportion of subjects with rash related dermatologic events
Proportion of subjects who develop treatment emergent cytopenic abnormalities
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
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
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
Proportion of subjects who achieve SVR12 with a 24-week treatment regimen
Proportion of subjects who achieve Extended rapid virologic response (eRVR) (HCV RNA < LLOQ target not detected at Weeks 4 and 12 of treatment)
Patient Health Questionnaire-9 (PHQ-9) score through end of follow-up
Proportion of subjects with treatment emergent laboratory abnormalities by toxicity grade through End of treatment (EOT)
Proportion of subjects with the following on-treatment interferon-associated neuropsychiatric symptoms through EOT
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
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
Full Information
NCT ID
NCT01718158
First Posted
October 29, 2012
Last Updated
September 23, 2015
Sponsor
Bristol-Myers Squibb
1. Study Identification
Unique Protocol Identification Number
NCT01718158
Brief Title
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
Acronym
STRUCTURE
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 Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
444 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Peginterferon Lambda-1a + Ribavirin + Daclatasvir
Arm Type
Experimental
Arm Description
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
Arm Title
Peginterferon Alfa-2a + Ribavirin + Telaprevir
Arm Type
Experimental
Arm Description
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
Intervention Type
Biological
Intervention Name(s)
Peginterferon Lambda-1a
Other Intervention Name(s)
BMS-914143
Intervention Type
Biological
Intervention Name(s)
Peginterferon Alfa-2a
Other Intervention Name(s)
Pegasys®
Intervention Type
Drug
Intervention Name(s)
Ribavirin
Other Intervention Name(s)
Copegus®
Intervention Type
Drug
Intervention Name(s)
Daclatasvir
Other Intervention Name(s)
BMS-790052
Intervention Type
Drug
Intervention Name(s)
Telaprevir
Other Intervention Name(s)
Incivek®
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Proportion of subjects who achieve SVR12 in treatment-naive subjects
Time Frame
Post treatment follow-up Week 12
Title
Proportion of subjects with rash related dermatologic events
Time Frame
Up to 12 weeks of treatment
Title
Proportion of subjects who develop treatment emergent cytopenic abnormalities
Description
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]
Time Frame
Up to 48 Weeks
Title
Proportion of subjects with on-treatment interferon (IFN) associated flu like/musculoskeletal symptoms
Time Frame
Up to 48 Weeks
Title
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
Description
SVR24 = Sustained virologic response at post treatment follow-up Week 24
Time Frame
Post treatment follow-up Week 24
Title
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
Title
Proportion of subjects who achieve SVR12 with a 24-week treatment regimen
Time Frame
Post treatment follow-up Week 12
Title
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
Title
Patient Health Questionnaire-9 (PHQ-9) score through end of follow-up
Time Frame
Maximum of 72 weeks
Title
Proportion of subjects with treatment emergent laboratory abnormalities by toxicity grade through End of treatment (EOT)
Time Frame
Maximum of 72 weeks
Title
Proportion of subjects with the following on-treatment interferon-associated neuropsychiatric symptoms through EOT
Description
Psychiatric symptoms (depression, irritability or insomnia)
Time Frame
Maximum of 48 weeks
Title
Association of Single nucleotide polymorphism (SNPs) in Interleukin 28B (IL28B) (including rs12979860) or equilibrative nucleoside transporter 1 (ENT1) with clinical responses
Description
For each SNP in each candidate gene, allele and genotype frequencies will be summarized by treatment regimen
Time Frame
Post-treatment follow-up Week 12
Title
Resistant variants associated with virologic failure through end of follow-up
Time Frame
Maximum of 72 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Va Long Beach Healthcare System
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
Facility Name
Gastrointestinal Specialists Of Georgia Pc
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Premier Medical Group Of The Hudson Valley, Pc
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Facility Name
Lehigh Valley Health Network
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18102
Country
United States
Facility Name
Nashville Medical Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Texas Clinical Research Institute, Llc
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Medvamc
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Local Institution
City
Capital Federal
State/Province
Buenos Aires
ZIP/Postal Code
C1405BCK
Country
Argentina
Facility Name
Local Institution
City
Mar Del Plata
State/Province
Buenos Aires
ZIP/Postal Code
B7600FZN
Country
Argentina
Facility Name
Local Institution
City
Prov De Santa Fe
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Local Institution
City
Buenos Aires
ZIP/Postal Code
1119
Country
Argentina
Facility Name
Local Institution
City
Buenos Aires
ZIP/Postal Code
1221
Country
Argentina
Facility Name
Local Institution
City
Buenos Aires
ZIP/Postal Code
C1181
Country
Argentina
Facility Name
Local Institution
City
Clichy Cedex
ZIP/Postal Code
92118
Country
France
Facility Name
Local Institution
City
Grenoble Cedex 9
ZIP/Postal Code
38043
Country
France
Facility Name
Local Institution
City
Villejuif Cedex
ZIP/Postal Code
94804
Country
France
Facility Name
Local Institution
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Local Institution
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Local Institution
City
Hamburg
ZIP/Postal Code
20099
Country
Germany
Facility Name
Local Institution
City
Mannheim
ZIP/Postal Code
68167
Country
Germany
Facility Name
Local Institution
City
Muenchen
ZIP/Postal Code
81377
Country
Germany
Facility Name
Local Institution
City
Haifa
ZIP/Postal Code
34362
Country
Israel
Facility Name
Local Institution
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Local Institution
City
Tel-Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
Local Institution
City
Zafed
ZIP/Postal Code
13110
Country
Israel
Facility Name
Local Institution
City
Foggia
ZIP/Postal Code
71100
Country
Italy
Facility Name
Local Institution
City
Messina
ZIP/Postal Code
98125
Country
Italy
Facility Name
Local Institution
City
Modena
ZIP/Postal Code
41100
Country
Italy
Facility Name
Local Institution
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Local Institution
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Facility Name
Local Institution
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
4678602
Country
Japan
Facility Name
Local Institution
City
Kitakyushu-shi
State/Province
Fukuoka
ZIP/Postal Code
8028533
Country
Japan
Facility Name
Local Institution
City
Kitakyushu
State/Province
Fukuoka
ZIP/Postal Code
8030816
Country
Japan
Facility Name
Local Institution
City
Hiroshima-shi
State/Province
Hiroshima
ZIP/Postal Code
7348511
Country
Japan
Facility Name
Local Institution
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
0600033
Country
Japan
Facility Name
Local Institution
City
Kobe-shi
State/Province
Hyogo
ZIP/Postal Code
6500047
Country
Japan
Facility Name
Local Institution
City
Higashiibaraki-gun
State/Province
Ibaraki
ZIP/Postal Code
3313193
Country
Japan
Facility Name
Local Institution
City
Kawasaki-shi
State/Province
Kanagawa
ZIP/Postal Code
2138587
Country
Japan
Facility Name
Local Institution
City
Yokohama-shi
State/Province
Kanagawa
ZIP/Postal Code
2458575
Country
Japan
Facility Name
Local Institution
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
2320024
Country
Japan
Facility Name
Local Institution
City
Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
6028566
Country
Japan
Facility Name
Local Institution
City
Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
6128555
Country
Japan
Facility Name
Local Institution
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
1058470
Country
Japan
Facility Name
Local Institution
City
Musashino-shi
State/Province
Tokyo
ZIP/Postal Code
1808610
Country
Japan
Facility Name
Local Institution
City
Sumida-ku
State/Province
Tokyo
ZIP/Postal Code
1308575
Country
Japan
Facility Name
Local Institution
City
Tanabe-shi
State/Province
Wakayama
ZIP/Postal Code
6468558
Country
Japan
Facility Name
Local Institution
City
Gifu
ZIP/Postal Code
5008727
Country
Japan
Facility Name
Local Institution
City
Kumamoto
ZIP/Postal Code
8628655
Country
Japan
Facility Name
Local Institution
City
Saga
ZIP/Postal Code
8408571
Country
Japan
Facility Name
Local Institution
City
Busan
ZIP/Postal Code
614-735
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
110-774
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
135-720
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Local Institution
City
Seoul
ZIP/Postal Code
143-729
Country
Korea, Republic of
Facility Name
Local Institution
City
Bialystok
ZIP/Postal Code
15-540
Country
Poland
Facility Name
Local Institution
City
Lodz
ZIP/Postal Code
91-347
Country
Poland
Facility Name
Local Institution
City
Myslowice
ZIP/Postal Code
41-400
Country
Poland
Facility Name
Local Institution
City
Wroclaw
ZIP/Postal Code
50-349
Country
Poland
Facility Name
Local Institution
City
Moscow
ZIP/Postal Code
111123
Country
Russian Federation
Facility Name
Local Institution
City
Moscow
ZIP/Postal Code
119991
Country
Russian Federation
Facility Name
Local Institution
City
Moscow
ZIP/Postal Code
119992
Country
Russian Federation
Facility Name
Local Institution
City
Moscow
ZIP/Postal Code
121170
Country
Russian Federation
Facility Name
Local Institution
City
Moscow
ZIP/Postal Code
125367
Country
Russian Federation
Facility Name
Local Institution
City
St. Petersburg
ZIP/Postal Code
191167
Country
Russian Federation
Facility Name
Local Institution
City
St. Petersburg
ZIP/Postal Code
196645
Country
Russian Federation
Facility Name
Local Institution
City
Stavropol
ZIP/Postal Code
355017
Country
Russian Federation
Facility Name
Local Institution
City
Barcelona
ZIP/Postal Code
08916
Country
Spain
Facility Name
Local Institution
City
Madrid
ZIP/Postal Code
28029
Country
Spain
Facility Name
Local Institution
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Local Institution
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Local Institution
City
Kaohsiung
ZIP/Postal Code
80756
Country
Taiwan
Facility Name
Local Institution
City
Taichung
ZIP/Postal Code
404
Country
Taiwan
Facility Name
Local Institution
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
Local Institution
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Local Institution
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Local Institution
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Local Institution
City
London
State/Province
Greater London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
27327078
Citation
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.
Results Reference
derived
Links:
URL
http://www.bms.com/studyconnect/Pages/home.aspx
Description
BMS clinical trial educational resource
Learn more about this trial
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
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