Phase III Daclatasvir and Sofosbuvir for Genotype 3 Chronic HCV

NCT02032901 | Completed Phase 3 Results

• 1 other identifier: AI444-218
• Study Type: interventional
• Target: 173
• Locations: 2 countries
• Sites: 31

Brief Summary

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

Conditions

Hepatitis C

Outcome Measures

Primary Outcomes (2)

• 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)

• 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)

Secondary Outcomes (8)

• Percentage of Participants With Rapid Virologic Response at Week 4 (RVR) Target Not Detected (TND)

  Week 4

• Percentage of Participants With Complete Early Virologic Response (cEVR) Target Not Detected (TND)

  Week 12

• Percentage of Participants With End of Treatment Response (EOTR) Target Not Detected (TND)

  Up to the end of treatment (up to 24 weeks)

• Percentage of Participants Who Achieved Hepatitis C Virus (HCV) RNA Levels Less Than the Lower Limit of Quantitation (LLOQ) - Target Not Detected (TND)

  Week 1, 2, 6, 8 (treatment period)

• 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)

  Week 1, 2, 4, 6, 8, 12, End of treatment (treatment period), Week 4 (follow-up period), Week 24 (follow-up period)

Study Arms (2)

A1:Daclatasvir + Sofosbuvir in treatment-naive subjects

EXPERIMENTAL

Daclatasvir 60 mg tablet and Sofosbuvir 400 mg tablet orally once daily for 12 weeks

Drug: Daclatasvir; Drug: Sofosbuvir

A2:Daclatasvir + Sofosbuvir in treatment-experienced subjects

EXPERIMENTAL

Daclatasvir 60 mg tablet and Sofosbuvir 400 mg tablet orally once daily for 12 weeks

Drug: Daclatasvir; Drug: Sofosbuvir

Interventions

Daclatasvir DRUG

Also known as: BMS-790052

A1:Daclatasvir + Sofosbuvir in treatment-naive subjects; A2:Daclatasvir + Sofosbuvir in treatment-experienced subjects

Sofosbuvir DRUG

A1:Daclatasvir + Sofosbuvir in treatment-naive subjects; A2:Daclatasvir + Sofosbuvir in treatment-experienced subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (31)

Scripps Clinic

La Jolla, California, 92037, United States

Location

Peter J Ruane MD Inc

Los Angeles, California, 90036, United States

Location

National Research Institute

Los Angeles, California, 90057, United States

Location

Anthony M. Mills MD Inc

Los Angeles, California, 90069, United States

Location

Huntington Medical Research Institutes

Pasadena, California, 91105, United States

Location

Precision Research Institute, LLC

San Diego, California, 92114, United States

Location

Medical Associates Research Group

San Diego, California, 92123, United States

Location

Quest Clinical Research

San Francisco, California, 94115, United States

Location

Midland Florida Clinical Research Center, LLC

DeLand, Florida, 32720, United States

Location

University of Florida Hepatology Research

Gainesville, Florida, 32610, United States

Location

Atlanta Gastroenterology Associates

Atlanta, Georgia, 30308, United States

Location

Gastrointestinal Specialists Of Georgia

Marietta, Georgia, 30060, United States

Location

Dupage Medical Group

Downers Grove, Illinois, 60515, United States

Location

Mercy Medical Center, Inc.

Baltimore, Maryland, 21202, United States

Location

Digestive Disease Associates, P.A.

Baltimore, Maryland, 21229, United States

Location

Kansas City Research Institute

Kansas City, Missouri, 64131, United States

Location

Southwest Care Center

Santa Fe, New Mexico, 87505, United States

Location

North Shore University Hospital

Manhasset, New York, 11030, United States

Location

Premier Medical Group Of The Hudson Valley, Pc

Poughkeepsie, New York, 12601, United States

Location

Asheville Gastroenterology Associates, PA

Asheville, North Carolina, 28801, United States

Location

Digestive Health Specialists, PA

Winston-Salem, North Carolina, 27103, United States

Location

Main Line Gastroenterology Associates Pc

Perkasie, Pennsylvania, 18944, United States

Location

Center For Liver Diseases

Pittsburgh, Pennsylvania, 15213, United States

Location

Gastro One

Germantown, Tennessee, 38138, United States

Location

Texas Clinical Research Institute, LLC

Arlington, Texas, 76012, United States

Location

American Research Corporation

San Antonio, Texas, 78215, United States

Location

Clinical Research Centers Of America

Murray, Utah, 84123, United States

Location

Lifetree Clinical Research

Salt Lake City, Utah, 84106, United States

Location

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

Fundacion De Investigacion De Diego

San Juan, 00927, Puerto Rico

Location

Related Publications (2)

• 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.

  PMID: 27188960 DERIVED

• 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.

  PMID: 25614962 DERIVED

Related Links

• BMS clinical trial educational resource
• Investigator Inquiry form

MeSH Terms

Conditions

Hepatitis C

Interventions

daclatasvir; Sofosbuvir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2014
• First Posted: January 10, 2014
• Study Start: January 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: December 1, 2014
• Last Updated: October 1, 2015
• Results First Posted: September 14, 2015

Record last verified: 2015-09

Locations

US (30); PR (1)