Study in Genotype 2 or 3 Patients With Chronic Hepatitis Virus Infection
NCT ID: NCT01257204
Last Updated: 2015-12-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
196 participants
INTERVENTIONAL
2010-12-31
2012-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Control
Placebo + Pegylated interferon alfa-2a + Ribavirin
Placebo
Tablets, oral, 0 mg, once daily, for 24 weeks
Pegylated interferon alfa-2a
Solution for injection, subcutaneous injection, 180 µg/0.5 mL, once weekly, for 12, 16, or 24 weeks
Ribavirin
Tablets, oral, 800 mg, twice daily, for 12, 16, or 24 weeks
12 Week Cohort
Daclatasvir + Pegylated interferon alfa-2a + Ribavirin
Daclatasvir
Tablets, oral, 60 mg, once daily, for 12, 16, or 24 weeks
Pegylated interferon alfa-2a
Solution for injection, subcutaneous injection, 180 µg/0.5 mL, once weekly, for 12, 16, or 24 weeks
Ribavirin
Tablets, oral, 800 mg, twice daily, for 12, 16, or 24 weeks
16 Week Cohort
Daclatasvir + Pegylated interferon alfa-2a + Ribavirin
Daclatasvir
Tablets, oral, 60 mg, once daily, for 12, 16, or 24 weeks
Pegylated interferon alfa-2a
Solution for injection, subcutaneous injection, 180 µg/0.5 mL, once weekly, for 12, 16, or 24 weeks
Ribavirin
Tablets, oral, 800 mg, twice daily, for 12, 16, or 24 weeks
Interventions
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Placebo
Tablets, oral, 0 mg, once daily, for 24 weeks
Daclatasvir
Tablets, oral, 60 mg, once daily, for 12, 16, or 24 weeks
Pegylated interferon alfa-2a
Solution for injection, subcutaneous injection, 180 µg/0.5 mL, once weekly, for 12, 16, or 24 weeks
Ribavirin
Tablets, oral, 800 mg, twice daily, for 12, 16, or 24 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
* Positive hepatitis B virus surface antigen, HIV-1 or HIV-2 Ab
* Prior exposure to any HCV direct antiviral agent (eg, HCV protease, polymerase, previous nonstructural protein 5A inhibitors)
* Exposure to any investigational drug or placebo
18 Years
70 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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California Liver Institute
Los Angeles, California, United States
Digestive Disease Associates, P.A.
Baltimore, Maryland, United States
Options Health Research, Llc
Tulsa, Oklahoma, United States
Alamo Medical Research
San Antonio, Texas, United States
Local Institution
Darlinghurst, New South Wales, Australia
Local Institution
Westmead Nsw, New South Wales, Australia
Local Institution
Adelaide, South Australia, Australia
Local Institution
Clayton Vic, Victoria, Australia
Local Institution
Fremantle, Western Australia, Australia
Local Institution
Camperdown, , Australia
Local Institution
Calgary, Alberta, Canada
Local Institution
Edmonton, Alberta, Canada
Local Institution
Vancouver, British Columbia, Canada
Local Institution
Victoria, British Columbia, Canada
Local Institution
Winnipeg, Manitoba, Canada
Local Institution
Toronto, Ontario, Canada
Local Institution
Hvidovre, , Denmark
Local Institution
Créteil, , France
Local Institution
Lille, , France
Local Institution
Montpellier, , France
Local Institution
Nice, , France
Local Institution
Paris, , France
Local Institution
Pessac, , France
Local Institution
Brescia, , Italy
Local Institution
Cisanello (pisa), , Italy
Local Institution
Viale Del Policlinico, 155, , Italy
Countries
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References
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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.
Related Links
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BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
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2010-022408-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AI444-031
Identifier Type: -
Identifier Source: org_study_id