Study in Genotype 2 or 3 Patients With Chronic Hepatitis Virus Infection
A Phase 2B Pilot Study of Short-Term Treatment of BMS-790052 in Combination With Peg-Interferon Alfa-2a and Ribavirin in Treatment Naive Subjects With Chronic Hepatitis C Genotype 2 or 3 Infection
2 other identifiers
interventional
196
6 countries
26
Brief Summary
To identify a shorter duration of antiviral therapy (12 or 16 weeks) for the combination of daclatasvir with pegylated interferon alfa-2a and ribavirin.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Dec 2010
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 1, 2010
CompletedStudy Start
First participant enrolled
December 1, 2010
CompletedFirst Posted
Study publicly available on registry
December 9, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2012
CompletedResults Posted
Study results publicly available
December 14, 2015
CompletedDecember 14, 2015
November 1, 2015
1.4 years
December 1, 2010
August 5, 2015
November 10, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 24 (SVR24) for Hepatitis C Virus (HCV) Genotype 2
SVR24 was defined as undetectable HCV RNA (HCV RNA \<lower limit of quantitation \[LLOQ\], target not detected \[TND\]) at follow-up Week 24. The LLOQ was 25 IU/mL, and \<LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Follow-up Week 24
Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 24 (SVR24) for Hepatitis C Virus (HCV) Genotype 3
SVR24 was defined as undetectable HCV RNA (HCV RNA \<lower limit of quantitation \[LLOQ\], target not detected \[TND\]) at follow-up Week 24. The LLOQ was 25 IU/mL, and \<LLOQ, TND was 10 IU/mL. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Follow-up Week 24
Secondary Outcomes (10)
Percentage of Participants Achieving Rapid Virologic Response (RVR) at Week 4 for Hepatitis C Virus (HCV) Genotype 2
Week 4
Percentage of Participants Achieving Rapid Virologic Response (RVR) at Week 4 for Hepatitis C Virus (HCV) Genotype 3
Week 4
Percentage of Participants Achieving Complete Early Virologic Response (cEVR) at Week 12 for Hepatitis C Virus (HCV) Genotype 2
Week 12
Percentage of Participants Achieving Complete Early Virologic Response (cEVR) at Week 12 for Hepatitis C Virus (HCV) Genotype 3
Week 12
Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 12 (SVR12) for Hepatitis C Virus (HCV) Genotype 2
Follow-up Week 12
- +5 more secondary outcomes
Study Arms (3)
Control
ACTIVE COMPARATORPlacebo + Pegylated interferon alfa-2a + Ribavirin
12 Week Cohort
EXPERIMENTALDaclatasvir + Pegylated interferon alfa-2a + Ribavirin
16 Week Cohort
EXPERIMENTALDaclatasvir + Pegylated interferon alfa-2a + Ribavirin
Interventions
Tablets, oral, 60 mg, once daily, for 12, 16, or 24 weeks
Solution for injection, subcutaneous injection, 180 µg/0.5 mL, once weekly, for 12, 16, or 24 weeks
Tablets, oral, 800 mg, twice daily, for 12, 16, or 24 weeks
Eligibility Criteria
You may qualify if:
- Participants chronically infected with hepatitis C virus (HCV) genotype 2 or 3
- No previous exposure to an interferon formulation (ie, interferon alfa, pegylated interferon alfa-2a ) or ribavirin
- Body mass index (BMI) of 18 to 35 kg/m\^2, inclusive. BMI=weight (kg)/height (m)\^2
- Males and females, 18 - 70 years of age
You may not qualify if:
- Liver transplant recipients
- Documented or suspected hepatocellular carcinoma
- Evidence of decompensated cirrhosis
- History of chronic hepatitis B virus (HBV). Patients with resolved HBV infection may participate
- Current or known history of cancer
- Any gastrointestinal disease or surgical procedure that may impact the absorption of study drug
- Inability to tolerate oral medication
- Poor venous access
- Severe psychiatric disease
- History of chronic pulmonary disease
- History of cardiomyopathy, coronary artery disease (including angina), interventive procedure for coronary artery disease (including angioplasty, stent procedure, or cardiac bypass surgery), ventricular arrhythmia,, or other clinically significant cardiac disease
- History of or current electrocardiogram findings indicative of cardiovascular instability
- Preexisting ophthalmologic disorders considered clinically significant on eye
- History of uncontrolled diabetes mellitus
- Any known contraindication to pegylated interferon alfa-2a or ribavirin not otherwise specified.
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
California Liver Institute
Los Angeles, California, 90048, United States
Digestive Disease Associates, P.A.
Baltimore, Maryland, 21229, United States
Options Health Research, Llc
Tulsa, Oklahoma, 74104, United States
Alamo Medical Research
San Antonio, Texas, 78215, United States
Local Institution
Darlinghurst, New South Wales, 2010, Australia
Local Institution
Westmead Nsw, New South Wales, 2145, Australia
Local Institution
Adelaide, South Australia, 5000, Australia
Local Institution
Clayton Vic, Victoria, 3168, Australia
Local Institution
Fremantle, Western Australia, 6160, Australia
Local Institution
Camperdown, NSW 2050, Australia
Local Institution
Calgary, Alberta, T2N 4Z6, Canada
Local Institution
Edmonton, Alberta, T6G 2B7, Canada
Local Institution
Vancouver, British Columbia, V6Z 2K5, Canada
Local Institution
Victoria, British Columbia, V8V 3P9, Canada
Local Institution
Winnipeg, Manitoba, R3E 3P4, Canada
Local Institution
Toronto, Ontario, M5G 2N2, Canada
Local Institution
Hvidovre, 2650, Denmark
Local Institution
Créteil, 94000, France
Local Institution
Lille, 59037, France
Local Institution
Montpellier, 34295, France
Local Institution
Nice, 06202, France
Local Institution
Paris, 75679, France
Local Institution
Pessac, 33604, France
Local Institution
Brescia, 25123, Italy
Local Institution
Cisanello (pisa), 56124, Italy
Local Institution
Viale Del Policlinico, 155, 00161, Italy
Related Publications (1)
Dore GJ, Lawitz E, Hezode C, Shafran SD, Ramji A, Tatum HA, Taliani G, Tran A, Brunetto MR, Zaltron S, Strasser SI, Weis N, Ghesquiere W, Lee SS, Larrey D, Pol S, Harley H, George J, Fung SK, de Ledinghen V, Hagens P, McPhee F, Hernandez D, Cohen D, Cooney E, Noviello S, Hughes EA. Daclatasvir plus peginterferon and ribavirin is noninferior to peginterferon and ribavirin alone, and reduces the duration of treatment for HCV genotype 2 or 3 infection. Gastroenterology. 2015 Feb;148(2):355-366.e1. doi: 10.1053/j.gastro.2014.10.007. Epub 2014 Oct 13.
PMID: 25311593DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Bristol-Myers Squibb Study Director
- Organization
- Bristol-Myers Squibb
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 1, 2010
First Posted
December 9, 2010
Study Start
December 1, 2010
Primary Completion
May 1, 2012
Study Completion
September 1, 2012
Last Updated
December 14, 2015
Results First Posted
December 14, 2015
Record last verified: 2015-11