Clinical trial NCT01428063: Study of pegInterferon Alfa-2a, Ribavirin, and Daclatasvir (BMS-790052) With or Without BMS-650032 for Participants in Some Hepatitis C Virus Trials
Official title: An Open-Label Re-Treatment Study With PegInterferon Alfa-2a, Ribavirin and BMS-790052 With or Without BMS-650032 for Subjects With Chronic Hepatitis C
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C Virus Infection
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2011-09-02
Enrollment: 276
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to provide anti-hepatitis C virus drugs to patients who received placebo + peginterferon alfa-2a + ribavirin in prior Bristol-Myers Squibb (BMS) studies and determine whether addition of these drugs results in higher cure rates in patients who previously failed therapy. Approximately 100 genotype 1b patients who received placebo in BMS study NCT01428063 (AI447-028) will receive active drugs in this study.

Detailed description: * Intervention Model:

  * Parallel: for all patients entering the trial
  * Cross-over: for genotype 1b patients rolling over from NCT01428063 (AI447-028) who require rescue therapy after initial treatment in this study
* Peginterferon alfa-2a
* Ribavirin
* Daclatasvir
* Asunaprevir

Eligibility criteria: Key Inclusion Criteria:

* Prior participation in any BMS-790052, BMS-650032, or BMS-791325 trial and assigned to control arm (pegIFNα-2a/ribavirin + placebo) during the trial
* Hepatitis C virus (HCV) genotype 1, 2, 3, or 4 (mixed genotypes are not permitted)
* HCV RNA viral load detectable

Key Exclusion Criteria:

* Discontinuation from a prior BMS HCV clinical trial due to a pegIFNα-2a/ribavirin-related event
* Any anti-HCV therapy following initial treatment with BMS-650032, BMS-790052, or BMS-791325
* Positive for hepatitis B infection (hepatitis B surface antigen) or HIV-1 or HIV-2 antibody at screening
* Evidence of medical condition associated with chronic liver disease other than HCV infection
* Evidence of decompensated cirrhosis based on radiologic criteria or biopsy

Primary outcomes:
measure: Percentage of Participants With Sustained Virologic Response at Week 12 (SVR12) for All Nonresponders With Genotype 1 Hepatitis C Virus (HCV)
timeFrame: Week 12 (Follow-up period)
Secondary outcomes:
measure: Percentage of Participants Other Than Genotype 1 With Sustained Virologic Response at Post Treatment Week 12 (SVR12)
timeFrame: Week 12 (Follow-up period)
measure: Percentage of Participants With Rapid Virologic Response (RVR) at Post Treatment Week 4
timeFrame: Week 4
measure: Percentage of Participants With Extended Rapid Virologic Response (eRVR)
timeFrame: Week 4 and 12
measure: Percentage of Participants With Complete Early Virologic Response (cEVR)
timeFrame: Week 12
measure: Percentage of Participants With End of the Treatment Response (EOTR)
timeFrame: End of the study (Week 24)
measure: Percentage of Participants With Sustained Virologic Response at Post Treatment Week 24 (SVR24)
timeFrame: Week 24 (Follow-up)
measure: Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to AEs, and Who Died During the Study
timeFrame: For AEs: Day 1 until last visit. For SAEs: Day 1 until 30 days post discontinuation of dosing or participation
Other outcomes:
Locations:
city: Montgomery
country: United States
facility: Baptist Medical Center South
state: Alabama
city: La Jolla
country: United States
facility: Scripps Clinic
state: California
city: Los Angeles
country: United States
facility: Scpmg/ Kaiser Permanente Los Angeles Medical Center
state: California
city: Aurora
country: United States
facility: University Of Colorado Denver And Hospital
state: Colorado
city: New Haven
country: United States
facility: Yale University School Of Medicine
state: Connecticut
city: Gainesville
country: United States
facility: Uf Hepatology Research At Ctrb
state: Florida
city: Miami
country: United States
facility: Schiff Center For Liver Diseases
state: Florida
city: Baltimore
country: United States
facility: Mercy Medical Center
state: Maryland
city: Catonsville
country: United States
facility: Digestive Disease Associates, P.A.
state: Maryland
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: St. Louis
country: United States
facility: Washington University School Of Medicine
state: Missouri
city: Manhasset
country: United States
facility: North Shore Long Island Jewish Health System
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Tulsa
country: United States
facility: Options Health Research, Llc
state: Oklahoma
city: Philadelphia
country: United States
facility: University Of Pennsylvania
state: Pennsylvania
city: Nashville
country: United States
facility: Nashville Medical Research Institute
state: Tennessee
city: Houston
country: United States
facility: Baylor College Of Medicine
state: Texas
city: San Antonio
country: United States
facility: Alamo Medical Research
state: Texas
city: Fairfax
country: United States
facility: Metropolitan Research
state: Virginia
city: Madison
country: United States
facility: Dean Clinic
state: Wisconsin
city: Ciudad De Buenos Aires
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Ciudad De Buenos Aires
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Prov. Buenos Aires
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Prov De Santa Fe
country: Argentina
facility: Local Institution
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Local Institution
city: Darlinghurst
country: Australia
facility: Local Institution
state: New South Wales
city: Kogarah
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: Fitzroy
country: Australia
facility: Local Institution
state: Victoria
city: Heidelberg
country: Australia
facility: Local Institution
state: Victoria
city: Melbourne
country: Australia
facility: Local Institution
state: Victoria
city: Fremantle
country: Australia
facility: Local Institution
state: Western Australia
city: Perth
country: Australia
facility: Local Institution
state: Western Australia
city: Graz
country: Austria
facility: Local Institution
city: Wien
country: Austria
facility: Local Institution
city: Vancouver
country: Canada
facility: Local Institution
state: British Columbia
city: Victoria
country: Canada
facility: Local Institution
state: British Columbia
city: Toronto
country: Canada
facility: Local Institution
state: Ontario
city: Toronto
country: Canada
facility: Local Institution
state: Ontario
city: Toronto
country: Canada
facility: Local Institution
state: Ontario
city: Vaughan
country: Canada
facility: Local Institution
state: Ontario
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Quebec
country: Canada
facility: Local Institution
city: Hvidovre
country: Denmark
facility: Local Institution
city: Bondy Cedex
country: France
facility: Local Institution
city: Clichy Cedex
country: France
facility: Local Institution
city: Creteil
country: France
facility: Local Institution
city: Creteil
country: France
facility: Local Institution
city: Lille
country: France
facility: Local Institution
city: Lyon Cedex 02
country: France
facility: Local Institution
city: Marseille Cedex 08
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 12
country: France
facility: Local Institution
city: Paris Cedex 13
country: France
facility: Local Institution
city: Paris Cedex 14
country: France
facility: Local Institution
city: Toulouse Cedex 09
country: France
facility: Local Institution
city: Toulouse
country: France
facility: Local Institution
city: Vandoeuvre Cedex
country: France
facility: Local Institution
city: Villejuif Cedex
country: France
facility: Local Institution
city: Berlin
country: Germany
facility: Local Institution
city: Berlin
country: Germany
facility: Local Institution
city: Bonn
country: Germany
facility: Local Institution
city: Frankfurt
country: Germany
facility: Local Institution
city: Hamburg
country: Germany
facility: Local Institution
city: Hannover
country: Germany
facility: Local Institution
city: Heidelberg
country: Germany
facility: Local Institution
city: Thesaloniki
country: Greece
facility: Local Institution
city: Dublin 8
country: Ireland
facility: Local Institution
state: Dublin
city: Dublin
country: Ireland
facility: Local Institution
city: Brescia
country: Italy
facility: Local Institution
city: Cisanello (pisa)
country: Italy
facility: Local Institution
city: Messina
country: Italy
facility: Local Institution
city: Milano
country: Italy
facility: Local Institution
city: Pavia
country: Italy
facility: Local Institution
city: Roma
country: Italy
facility: Local Institution
city: Roma
country: Italy
facility: Local Institution
city: Torino
country: Italy
facility: Local Institution
city: Viale Del Policlinico, 155
country: Italy
facility: Local Institution
city: Busan
country: Korea, Republic of
facility: Local Institution
city: Busan
country: Korea, Republic of
facility: Local Institution
city: Busan
country: Korea, Republic of
facility: Local Institution
city: Daegu
country: Korea, Republic of
facility: Local Institution
city: Daegu
country: Korea, Republic of
facility: Local Institution
city: Gyeonggi-do
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Guadalajara
country: Mexico
facility: Local Institution
state: Jalisco
city: Auckland
country: New Zealand
facility: Local Institution
city: Bialystok
country: Poland
facility: Local Institution
city: Wroclaw
country: Poland
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution
city: Gothenburg
country: Sweden
facility: Local Institution
city: Stockholm
country: Sweden
facility: Local Institution
city: Taichung
country: Taiwan
facility: Local Institution
city: Taichung
country: Taiwan
facility: Local Institution
city: Taipei
country: Taiwan
facility: Local Institution
city: Taipei
country: Taiwan
facility: Local Institution
city: London
country: United Kingdom
facility: Local Institution
state: Greater London
city: London
country: United Kingdom
facility: Local Institution
state: Greater London
city: London
country: United Kingdom
facility: Local Institution
state: Greater London
city: London
country: United Kingdom
facility: Local Institution
state: Greater London
city: Manchester
country: United Kingdom
facility: Local Institution
state: Greater Manchester
city: Glasgow
country: United Kingdom
facility: Local Institution
state: Lanarkshire
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: