Phase III Daclatasvir and Sofosbuvir for Genotype 3 Chronic HCV

Hepatitis C Clinical Trial

— ALLY 3  

Official title:

A Phase 3 Evaluation of Daclatasvir and Sofosbuvir in Treatment Naive and Treatment Experienced Subjects With Genotype 3 Chronic Hepatitis C Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02032901
• Other study ID #: AI444-218
• Status: Completed
• Phase: Phase 3
• First received: January 9, 2014
• Last updated: September 29, 2015
• Start date: January 2014
• Est. completion date: December 2014

Study information

• Verified date: September 2015
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 173
• Est. completion date: December 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C

Intervention

Drug:
• Daclatasvir

• Sofosbuvir

Locations

Country	Name	City	State
Puerto Rico	Fundacion De Investigacion De Diego	San Juan
United States	Texas Clinical Research Institute, LLC	Arlington	Texas
United States	Asheville Gastroenterology Associates, PA	Asheville	North Carolina
United States	Atlanta Gastroenterology Associates	Atlanta	Georgia
United States	Digestive Disease Associates, P.A.	Baltimore	Maryland
United States	Mercy Medical Center, Inc.	Baltimore	Maryland
United States	Midland Florida Clinical Research Center, LLC	Deland	Florida
United States	Dupage Medical Group	Downers Grove	Illinois
United States	Inova Fairfax Hospital	Falls Church	Virginia
United States	University of Florida Hepatology Research	Gainesville	Florida
United States	Gastro One	Germantown	Tennessee
United States	Kansas City Research Institute	Kansas City	Missouri
United States	Scripps Clinic	La Jolla	California
United States	Anthony M. Mills MD Inc	Los Angeles	California
United States	National Research Institute	Los Angeles	California
United States	Peter J Ruane MD Inc	Los Angeles	California
United States	North Shore University Hospital	Manhasset	New York
United States	Gastrointestinal Specialists Of Georgia	Marietta	Georgia
United States	Clinical Research Centers Of America	Murray	Utah
United States	Huntington Medical Research Institutes	Pasadena	California
United States	Main Line Gastroenterology Associates Pc	Perkasie	Pennsylvania
United States	Center For Liver Diseases	Pittsburgh	Pennsylvania
United States	Premier Medical Group Of The Hudson Valley, Pc	Poughkeepsie	New York
United States	Lifetree Clinical Research	Salt Lake City	Utah
United States	American Research Corporation	San Antonio	Texas
United States	Medical Associates Research Group	San Diego	California
United States	Precision Research Institute, LLC	San Diego	California
United States	Quest Clinical Research	San Francisco	California
United States	Southwest Care Center	Santa Fe	New Mexico
United States	Virginia Mason Medical Center	Seattle	Washington
United States	Digestive Health Specialists, PA	Winston-salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Treatment-Naive Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) Target Detected (TD) or Target Not Detected (TND)	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.	Week 12 (Follow-up period)	No
Primary	Percentage of Treatment-Experienced Participants With Sustained Virologic Response at Follow-up Week 12 (SVR12) Target Detected (TD) or Target Not Detected (TND)	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.	Week 12 (Follow-up period)	No
Secondary	Percentage of Participants With Rapid Virologic Response at Week 4 (RVR) Target Not Detected (TND)	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.	Week 4	No
Secondary	Percentage of Participants With Complete Early Virologic Response (cEVR) Target Not Detected (TND)	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.	Week 12	No
Secondary	Percentage of Participants With End of Treatment Response (EOTR) Target Not Detected (TND)	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.	Up to the end of treatment (up to 24 weeks)	No
Secondary	Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Less Than the Lower Limit of Quantitation (LLOQ) - Target Not Detected (TND)	Percentage of participants who achieved HCV RNA	Week 1, 2, 6, 8 (treatment period)	No
Secondary	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)	Percentage of participants who achieved HCV RNA	Week 1, 2, 4, 6, 8, 12, End of treatment (treatment period), Week 4 (follow-up period), Week 24 (follow-up period)	No
Secondary	Percentage of Participants With Or Without Cirrhosis at Baseline Who Achieved Sustained Virologic Response at Follow-up Week 12 (SVR12)	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.	Baseline, Week 12 (Follow-up period)	No
Secondary	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)	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.	Week 12 (Follow-up period)	No
Secondary	Number of Participants With Serious Adverse Events (SAEs) and Discontinuations Due to Adverse Events (AEs)	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.	From Day 1 first dose to last dose plus 7 days	Yes

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