Clinical trial NCT02032901: Phase III Daclatasvir and Sofosbuvir for Genotype 3 Chronic HCV
Official title: A Phase 3 Evaluation of Daclatasvir and Sofosbuvir in Treatment Naive and Treatment Experienced Subjects With Genotype 3 Chronic Hepatitis C Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2014-01-10
Enrollment: 173
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To study the combination of Daclatasvir and Sofosbuvir for the treatment of hepatitis C virus (HCV) Genotype 3 infection


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Treatment-Naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) Target Detected (TD) or Target Not Detected (TND)
timeFrame: Week 12 (Follow-up period)
measure: Percentage of Treatment-Experienced Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) Target Detected (TD) or Target Not Detected (TND)
timeFrame: Week 12 (Follow-up period)
Secondary outcomes:
measure: Percentage of Participants With Rapid Virologic Response at Week 4 (RVR) Target Not Detected (TND)
timeFrame: Week 4
measure: Percentage of Participants With Complete Early Virologic Response (cEVR) Target Not Detected (TND)
timeFrame: Week 12
measure: Percentage of Participants With End of Treatment Response (EOTR) Target Not Detected (TND)
timeFrame: Up to the end of treatment (up to 24 weeks)
measure: Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Less Than the Lower Limit of Quantitation (LLOQ) - Target Not Detected (TND)
timeFrame: Week 1, 2, 6, 8 (treatment period)
measure: 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)
timeFrame: Week 1, 2, 4, 6, 8, 12, End of treatment (treatment period), Week 4 (follow-up period), Week 24 (follow-up period)
measure: Percentage of Participants With Or Without Cirrhosis at Baseline Who Achieved Sustained Virologic Response at Follow-up Week 12 (SVR12)
timeFrame: Baseline, Week 12 (Follow-up period)
measure: 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)
timeFrame: Week 12 (Follow-up period)
measure: Number of Participants With Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs)
timeFrame: From Day 1 first dose to last dose plus 7 days
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Scripps Clinic
state: California
city: Los Angeles
country: United States
facility: Peter J Ruane MD Inc
state: California
city: Los Angeles
country: United States
facility: National Research Institute
state: California
city: Los Angeles
country: United States
facility: Anthony M. Mills MD Inc
state: California
city: Pasadena
country: United States
facility: Huntington Medical Research Institutes
state: California
city: San Diego
country: United States
facility: Precision Research Institute, LLC
state: California
city: San Diego
country: United States
facility: Medical Associates Research Group
state: California
city: San Francisco
country: United States
facility: Quest Clinical Research
state: California
city: Deland
country: United States
facility: Midland Florida Clinical Research Center, LLC
state: Florida
city: Gainesville
country: United States
facility: University of Florida Hepatology Research
state: Florida
city: Atlanta
country: United States
facility: Atlanta Gastroenterology Associates
state: Georgia
city: Marietta
country: United States
facility: Gastrointestinal Specialists Of Georgia
state: Georgia
city: Downers Grove
country: United States
facility: Dupage Medical Group
state: Illinois
city: Baltimore
country: United States
facility: Mercy Medical Center, Inc.
state: Maryland
city: Baltimore
country: United States
facility: Digestive Disease Associates, P.A.
state: Maryland
city: Kansas City
country: United States
facility: Kansas City Research Institute
state: Missouri
city: Santa Fe
country: United States
facility: Southwest Care Center
state: New Mexico
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: Poughkeepsie
country: United States
facility: Premier Medical Group Of The Hudson Valley, Pc
state: New York
city: Asheville
country: United States
facility: Asheville Gastroenterology Associates, PA
state: North Carolina
city: Winston-salem
country: United States
facility: Digestive Health Specialists, PA
state: North Carolina
city: Perkasie
country: United States
facility: Main Line Gastroenterology Associates Pc
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Center For Liver Diseases
state: Pennsylvania
city: Germantown
country: United States
facility: Gastro One
state: Tennessee
city: Arlington
country: United States
facility: Texas Clinical Research Institute, LLC
state: Texas
city: San Antonio
country: United States
facility: American Research Corporation
state: Texas
city: Murray
country: United States
facility: Clinical Research Centers Of America
state: Utah
city: Salt Lake City
country: United States
facility: Lifetree Clinical Research
state: Utah
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: San Juan
country: Puerto Rico
facility: Fundacion De Investigacion De Diego
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.