- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02032901
Phase III Daclatasvir and Sofosbuvir for Genotype 3 Chronic HCV (ALLY 3)
September 29, 2015 updated by: Bristol-Myers Squibb
A Phase 3 Evaluation of Daclatasvir and Sofosbuvir in Treatment Naive and Treatment Experienced Subjects With Genotype 3 Chronic Hepatitis C Infection
To study the combination of Daclatasvir and Sofosbuvir for the treatment of hepatitis C virus (HCV) Genotype 3 infection
Study Overview
Study Type
Interventional
Enrollment (Actual)
173
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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San Juan, Puerto Rico, 00927
- Fundacion de Investigacion de Diego
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California
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La Jolla, California, United States, 92037
- Scripps Clinic
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Los Angeles, California, United States, 90057
- National Research Institute
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Los Angeles, California, United States, 90036
- Peter J Ruane Md Inc
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Los Angeles, California, United States, 90069
- Anthony M. Mills Md Inc
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Pasadena, California, United States, 91105
- Huntington Medical Research Institutes
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San Diego, California, United States, 92123
- Medical Associates Research Group
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San Diego, California, United States, 92114
- Precision Research Institute, LLC
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San Francisco, California, United States, 94115
- Quest Clinical Research
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Florida
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Deland, Florida, United States, 32720
- Midland Florida Clinical Research Center, LLC
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Gainesville, Florida, United States, 32610
- University of Florida Hepatology Research
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Georgia
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Atlanta, Georgia, United States, 30308
- Atlanta Gastroenterology Associates
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Marietta, Georgia, United States, 30060
- Gastrointestinal Specialists of Georgia
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Illinois
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Downers Grove, Illinois, United States, 60515
- DuPage Medical Group
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Maryland
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Baltimore, Maryland, United States, 21202
- Mercy Medical Center, Inc.
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Baltimore, Maryland, United States, 21229
- Digestive Disease Associates, P.A.
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Missouri
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Kansas City, Missouri, United States, 64131
- Kansas City Research Institute
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New Mexico
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Santa Fe, New Mexico, United States, 87505
- Southwest CARE Center
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New York
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Manhasset, New York, United States, 11030
- North Shore University Hospital
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Poughkeepsie, New York, United States, 12601
- Premier Medical Group of the Hudson Valley, PC
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North Carolina
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Asheville, North Carolina, United States, 28801
- Asheville Gastroenterology Associates, PA
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Winston-salem, North Carolina, United States, 27103
- Digestive Health Specialists, PA
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Pennsylvania
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Perkasie, Pennsylvania, United States, 18944
- Main Line Gastroenterology Associates Pc
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Pittsburgh, Pennsylvania, United States, 15213
- Center For Liver Diseases
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Tennessee
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Germantown, Tennessee, United States, 38138
- Gastro One
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Texas
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Arlington, Texas, United States, 76012
- Texas Clinical Research Institute, LLC
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San Antonio, Texas, United States, 78215
- American Research Corporation
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Utah
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Murray, Utah, United States, 84123
- Clinical Research Centers Of America
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Salt Lake City, Utah, United States, 84106
- Lifetree Clinical Research
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Virginia
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Falls Church, Virginia, United States, 22042
- Inova Fairfax Hospital
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Washington
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Seattle, Washington, United States, 98101
- Virginia Mason Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com
Key Inclusion Criteria:
- Subjects must be able to understand and agree to comply with the prescribed dosing regimens and procedures, report for regularly scheduled study visits, and reliably communicate with study personnel about adverse events and concomitant medications
- Subjects chronically infected with hepatitis C virus (HCV) genotype 3
- Subjects who are HCV treatment-naive
- Subjects who are HCV treatment-experienced (previous exposure to non-structural 5A inhibitors is prohibited)
- HCV RNA ≥10,000 IU/mL at screening
Key Exclusion Criteria:
- HCV Genotypes other than genotype-3 infection; mixed genotype infections are not permitted
- Liver or any other organ transplant (including hematopoietic stem cell transplants) other than cornea and hair
- Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to screening
- Documented or suspected hepatocellular carcinoma, as evidenced by previously obtained imaging studies or liver biopsy (or on a screening imaging study/liver biopsy if this was performed)
- Evidence of decompensated liver disease including, but not limited to, radiologic criteria, a history or presence of ascites, bleeding varices, or hepatic encephalopathy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: A1:Daclatasvir + Sofosbuvir in treatment-naive subjects
Daclatasvir 60 mg tablet and Sofosbuvir 400 mg tablet orally once daily for 12 weeks
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Other Names:
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Experimental: A2:Daclatasvir + Sofosbuvir in treatment-experienced subjects
Daclatasvir 60 mg tablet and Sofosbuvir 400 mg tablet orally once daily for 12 weeks
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Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Treatment-Naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) Target Detected (TD) or Target Not Detected (TND)
Time Frame: Week 12 (Follow-up period)
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SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation ie., 25 IU/mL, TD or TND at follow-up Week 12. HCV RNA levels were measured by the Roche Cobas® TaqMan® HCV Test version 2.0 from the central laboratory.
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Week 12 (Follow-up period)
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Percentage of Treatment-Experienced Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) Target Detected (TD) or Target Not Detected (TND)
Time Frame: Week 12 (Follow-up period)
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SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation ie., 25 IU/mL, target detected or target not detected at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
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Week 12 (Follow-up period)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With Rapid Virologic Response at Week 4 (RVR) Target Not Detected (TND)
Time Frame: Week 4
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RVR was defined as hepatitis C virus RNA levels to be < lower limit of quantitation ie, 25 IU/mL TND at Week 4. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
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Week 4
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Percentage of Participants With Complete Early Virologic Response (cEVR) Target Not Detected (TND)
Time Frame: Week 12
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cEVR was defined as hepatitis C virus RNA levels to be < lower limit of quantitation ie, 25 IU/mL TND at Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
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Week 12
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Percentage of Participants With End of Treatment Response (EOTR) Target Not Detected (TND)
Time Frame: Up to the end of treatment (up to 24 weeks)
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EOTR were defined as hepatitis C virus RNA levels to be < lower limit of quantitation ie, 25 IU/mL TND at end of treatment.
HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
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Up to the end of treatment (up to 24 weeks)
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Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Less Than the Lower Limit of Quantitation (LLOQ) - Target Not Detected (TND)
Time Frame: Week 1, 2, 6, 8 (treatment period)
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Percentage of participants who achieved HCV RNA <LLOQ, TND was determined (LLOQ: 25 IU/mL).
HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
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Week 1, 2, 6, 8 (treatment period)
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Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Less Than the Lower Limit of Quantitation (LLOQ)- Target Detected (TD) or Target Not Detected (TND)
Time Frame: Week 1, 2, 4, 6, 8, 12, End of treatment (treatment period), Week 4 (follow-up period), Week 24 (follow-up period)
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Percentage of participants who achieved HCV RNA <LLOQ,TD or TND was determined (LLOQ: 25 IU/mL).
HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
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Week 1, 2, 4, 6, 8, 12, End of treatment (treatment period), Week 4 (follow-up period), Week 24 (follow-up period)
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Percentage of Participants With Or Without Cirrhosis at Baseline Who Achieved Sustained Virologic Response at Follow-up Week 12 (SVR12)
Time Frame: Baseline, Week 12 (Follow-up period)
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SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation ie. 25 IU/mL, target detected or target not detected at follow-up Week 12. Cirrhosis was considered a negative predictor of SVR in participants treated with an interferon formulation or ribavirin.
Presence or absence of cirrhosis was determined at baseline and follow-up Week 12 in the participants to evaluate the post-treatment relapse.
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Baseline, Week 12 (Follow-up period)
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Percentage of Participants With CC or Non-CC Genotype at the IL28B rs12979860 Single Nucleotide Polymorphisms (SNPs) Who Achieved Sustained Virologic Response After 12 Weeks of Follow-up (SVR12)
Time Frame: Week 12 (Follow-up period)
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Participants categorized into 2 genotypes (CC and non-CC) based on SNPs in the IL28B gene were assessed for SVR12, defined as response in which hepatitis C virus (HCV) RNA levels below lower limit of quantitation (LLOQ) below target detected or target not detected at follow-up Week 12 (LLOQ: 25 IU/mL).
HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
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Week 12 (Follow-up period)
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Number of Participants With Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs)
Time Frame: From Day 1 first dose to last dose plus 7 days
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AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not necessarily have a causal relationship with treatment.
SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.
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From Day 1 first dose to last dose plus 7 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Kowdley KV, Nelson DR, Lalezari JP, Box T, Gitlin N, Poleynard G, Rabinovitz M, Ravendhran N, Sheikh AM, Siddique A, Bhore R, Noviello S, Rana K. On-treatment HCV RNA as a predictor of sustained virological response in HCV genotype 3-infected patients treated with daclatasvir and sofosbuvir. Liver Int. 2016 Nov;36(11):1611-1618. doi: 10.1111/liv.13165. Epub 2016 Jun 16.
- Nelson DR, Cooper JN, Lalezari JP, Lawitz E, Pockros PJ, Gitlin N, Freilich BF, Younes ZH, Harlan W, Ghalib R, Oguchi G, Thuluvath PJ, Ortiz-Lasanta G, Rabinovitz M, Bernstein D, Bennett M, Hawkins T, Ravendhran N, Sheikh AM, Varunok P, Kowdley KV, Hennicken D, McPhee F, Rana K, Hughes EA; ALLY-3 Study Team. All-oral 12-week treatment with daclatasvir plus sofosbuvir in patients with hepatitis C virus genotype 3 infection: ALLY-3 phase III study. Hepatology. 2015 Apr;61(4):1127-35. doi: 10.1002/hep.27726. Epub 2015 Mar 10.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2014
Primary Completion (Actual)
September 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
January 9, 2014
First Submitted That Met QC Criteria
January 9, 2014
First Posted (Estimate)
January 10, 2014
Study Record Updates
Last Update Posted (Estimate)
October 1, 2015
Last Update Submitted That Met QC Criteria
September 29, 2015
Last Verified
September 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AI444-218
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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