Clinical trial NCT01257204: Study in Genotype 2 or 3 Patients With Chronic Hepatitis Virus Infection
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C Virus
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2010-12-09
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Key Inclusion Criteria:

* 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

Key Exclusion Criteria:

* 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.
* 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

Primary outcomes:
measure: Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 24 (SVR24) for Hepatitis C Virus (HCV) Genotype 2
timeFrame: Follow-up Week 24
measure: Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 24 (SVR24) for Hepatitis C Virus (HCV) Genotype 3
timeFrame: Follow-up Week 24
Secondary outcomes:
measure: Percentage of Participants Achieving Rapid Virologic Response (RVR) at Week 4 for Hepatitis C Virus (HCV) Genotype 2
timeFrame: Week 4
measure: Percentage of Participants Achieving Rapid Virologic Response (RVR) at Week 4 for Hepatitis C Virus (HCV) Genotype 3
timeFrame: Week 4
measure: Percentage of Participants Achieving Complete Early Virologic Response (cEVR) at Week 12 for Hepatitis C Virus (HCV) Genotype 2
timeFrame: Week 12
measure: Percentage of Participants Achieving Complete Early Virologic Response (cEVR) at Week 12 for Hepatitis C Virus (HCV) Genotype 3
timeFrame: Week 12
measure: Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 12 (SVR12) for Hepatitis C Virus (HCV) Genotype 2
timeFrame: Follow-up Week 12
measure: Percentage of Participants Achieving Sustained Virologic Response at Follow-up Week 12 (SVR12) for Hepatitis C Virus (HCV) Genotype 3
timeFrame: Follow-up Week 12
measure: Number of Participants With Virologic Failure for Hepatitis C Virus (HCV) Genotype 2
timeFrame: Baseline up to Week 48
measure: Number of Participants With Virologic Failure for Hepatitis C Virus (HCV) Genotype 3
timeFrame: Baseline up to Week 48
measure: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Treatment-related AEs and Who Died During Treatment Period
timeFrame: Baseline (Day 1) up to 24 weeks (treatment period)
measure: Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Who Died During Follow-up Period
timeFrame: From end of treatment period up to Week 48 (follow-up period)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: California Liver Institute
state: California
city: Baltimore
country: United States
facility: Digestive Disease Associates, P.A.
state: Maryland
city: Tulsa
country: United States
facility: Options Health Research, Llc
state: Oklahoma
city: San Antonio
country: United States
facility: Alamo Medical Research
state: Texas
city: Darlinghurst
country: Australia
facility: Local Institution
state: New South Wales
city: Westmead Nsw
country: Australia
facility: Local Institution
state: New South Wales
city: Adelaide
country: Australia
facility: Local Institution
state: South Australia
city: Clayton Vic
country: Australia
facility: Local Institution
state: Victoria
city: Fremantle
country: Australia
facility: Local Institution
state: Western Australia
city: Camperdown
country: Australia
facility: Local Institution
city: Calgary
country: Canada
facility: Local Institution
state: Alberta
city: Edmonton
country: Canada
facility: Local Institution
state: Alberta
city: Vancouver
country: Canada
facility: Local Institution
state: British Columbia
city: Victoria
country: Canada
facility: Local Institution
state: British Columbia
city: Winnipeg
country: Canada
facility: Local Institution
state: Manitoba
city: Toronto
country: Canada
facility: Local Institution
state: Ontario
city: Hvidovre
country: Denmark
facility: Local Institution
city: Creteil
country: France
facility: Local Institution
city: Lille Cedex
country: France
facility: Local Institution
city: Montpellier Cedex 5
country: France
facility: Local Institution
city: Nice Cedex 03
country: France
facility: Local Institution
city: Paris Cedex 14
country: France
facility: Local Institution
city: Pessac
country: France
facility: Local Institution
city: Brescia
country: Italy
facility: Local Institution
city: Cisanello (pisa)
country: Italy
facility: Local Institution
city: Viale Del Policlinico, 155
country: Italy
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: 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.