Clinical trial NCT01492504: Three-year Follow-up Study of Subjects Who Participated in a Previous Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052) Chronic Hepatitis C Clinical Trial
Official title: A Long-Term Follow-up Study of Subjects Who Participated in a Clinical Trial in Which Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052) Was Administered for the Treatment of Chronic Hepatitis C
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2011-12-15
Enrollment: 1850
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who participated in a clinical trial in which Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052) was administered for the treatment of chronic hepatitis C

Brief summary: The primary purpose of this study is to determine whether the hepatitis C virus continues to remain unable to be detected in subjects who were previously treated with Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052) and achieved sustained virologic response.


Eligibility criteria: Inclusion Criteria

* Signed Written Informed Consent
* Subjects must have received at least one dose of Asunaprevir and/or Daclatasvir
* Subjects participating in Daclatasvir and/or Asunaprevir studies (ie, protocol numbers beginning with AI443, AI444 or AI447) may enroll regardless of virologic response
* Completed the required post-treatment follow-up period in previous study
* Must enroll in this study within 6 months of completing previous BMS study or within 6 months of protocol availability at the clinical site
* Men and women, ages 18 and older

Exclusion Criteria:

* Subject must not have been treated with any antiviral or immunomodulatory drug for chronic hepatitis C (CHC) after completion of the previous study during which Asunaprevir and/or Daclatasvir were administered
* Subject must not be participating in any other trial, excluding non-interventional trials
* Prisoners or subjects who are involuntarily incarcerated
* Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness

Primary outcomes:
measure: Durability of Sustained viral response [SVR] (time to loss of virologic response)
timeFrame: 24 or 48-week Intervals
Secondary outcomes:
measure: Frequency of viral genotypic substitutions in subjects previously treated with Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052) who did not achieve or did not maintain SVR12
timeFrame: 24 or 48-week intervals
measure: Long-term progression of liver disease, as measured by the frequency of hepatic disease progression, all cause mortality, and liver-related mortality
timeFrame: 24 or 48-week intervals
Other outcomes:
Locations:
city: Montgomery
country: United States
facility: Alabama Liver & Digestive Specialists (Alds)
state: Alabama
city: Beverly Hills
country: United States
facility: Pacific Oaks Medical Group
state: California
city: Coronado
country: United States
facility: Southern California Research Center
state: California
city: La Jolla
country: United States
facility: Scripps Clinic
state: California
city: Los Angeles
country: United States
facility: Keck Medical Center of USC, HCC 1
state: California
city: Los Angeles
country: United States
facility: Peter J Ruane Md Inc
state: California
city: Los Angeles
country: United States
facility: Anthony M. Mills Md Inc
state: California
city: San Diego
country: United States
facility: Precision Research Institute, Llc
state: California
city: San Diego
country: United States
facility: Quest Clinical Research
state: California
city: San Diego
country: United States
facility: Medical Associates Research Group
state: California
city: San Francisco
country: United States
facility: U.Cal.-San Francisco
state: California
city: Aurora
country: United States
facility: University Of Colorado Denver & Hospital
state: Colorado
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Miami
country: United States
facility: Schiff Center for Liver Diseases
state: Florida
city: Miami
country: United States
facility: University Of Miami School Of Medicine
state: Florida
city: Orlando
country: United States
facility: Orlando Immunology Center
state: Florida
city: Orlando
country: United States
facility: Florida Hospital Transplant Center
state: Florida
city: Marietta
country: United States
facility: Gastrointestinal Specialists Of Georgia
state: Georgia
city: Chicago
country: United States
facility: Ruth M. Rothstein CORE Center
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
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: Lutherville
country: United States
facility: Johns Hopkins University
state: Maryland
city: Springfield
country: United States
facility: The Research Institute
state: Massachusetts
city: Ann Arbor
country: United States
facility: University Of Michigan
state: Michigan
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
city: Santa Fe
country: United States
facility: Southwest Care Center
state: New Mexico
city: Great Neck
country: United States
facility: Nyu Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University Of North Carolina At Chapel Hill School Of Med
state: North Carolina
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Statesville
country: United States
facility: Carolinas Center For Liver Disease
state: North Carolina
city: Tulsa
country: United States
facility: Mayo Clinic Rochester
state: Oklahoma
city: Tulsa
country: United States
facility: Healthcare Research Consultants
state: Oklahoma
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Allentown
country: United States
facility: Lehigh Valley Health Network
state: Pennsylvania
city: Philadelphia
country: United States
facility: University Of Pennsylvania School Of Medicine
state: Pennsylvania
city: Germantown
country: United States
facility: Gastro One
state: Tennessee
city: Nashville
country: United States
facility: Nashville Medical Research Institute
state: Tennessee
city: Arlington
country: United States
facility: Texas Clinical Research Institute
state: Texas
city: Houston
country: United States
facility: Baylor College Of Medicine
state: Texas
city: Houston
country: United States
facility: Liver Associates Of Texas
state: Texas
city: Houston
country: United States
facility: MEDVAMC
state: Texas
city: San Antonio
country: United States
facility: Alamo Medical Research
state: Texas
city: Salt Lake City
country: United States
facility: Lifetree Clinical Research
state: Utah
city: Annandale
country: United States
facility: Metropolitan Research
state: Virginia
city: Falls Church
country: United States
facility: Inova Fairfax Hospital
state: Virginia
city: Richmond
country: United States
facility: Bon Secours St. Mary's Hospital of Richmond, Inc.
state: Virginia
city: Richmond
country: United States
facility: Mcguire Dvamc
state: Virginia
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
city: Madison
country: United States
facility: Ssm Health Dean Med Group
state: Wisconsin
city: Ciudad De Buenos Aires
country: Argentina
facility: Fundacion Cidea De Paraguay
state: Buenos Aires
city: Mar Del Plata
country: Argentina
facility: Centro Oncologico Integral
state: Buenos Aires
city: Prov. Buenos Aires
country: Argentina
facility: Hospital Austral
state: Buenos Aires
city: Prov De Santa Fe
country: Argentina
facility: Instituto Centralizado De Asistencia E Investigacion Clinica
state: Santa FE
city: Buenos Aires
country: Argentina
facility: Local Institution
city: Buenos Aires
country: Argentina
facility: Hospital Italiano De Buenos Aires
city: Camperdown
country: Australia
facility: Local Institution
state: New South Wales
city: Darlinghurst Nsw
country: Australia
facility: Local Institution
state: New South Wales
city: Darlinghurst
country: Australia
facility: Local Institution
state: New South Wales
city: Randwick
country: Australia
facility: Local Institution
state: New South Wales
city: Westmead
country: Australia
facility: Local Institution
state: New South Wales
city: Woollongabba
country: Australia
facility: Local Institution
state: Queensland
city: Adelaide
country: Australia
facility: Local Institution
state: South Australia
city: Clayton Vic
country: Australia
facility: Local Institution
state: Victoria
city: Melbourne
country: Australia
facility: Local Institution
state: Victoria
city: Porto Alegre
country: Brazil
facility: Local Institution
state: RIO Grande DO SUL
city: Rio De Janeiro
country: Brazil
facility: Local Institution
city: Rio De Janeiro
country: Brazil
facility: Local Institution
city: Sao Paulo
country: Brazil
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: 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: Toronto General Hospital
state: Ontario
city: Regina
country: Canada
facility: Local Institution
state: Saskatchewan
city: Hvidovre
country: Denmark
facility: Local Institution
city: Odense
country: Denmark
facility: Local Institution
city: Clichy Cedex
country: France
facility: Local Institution
city: Creteil Cedex
country: France
facility: Local Institution
city: La Roche-sur-yon Cedex 9
country: France
facility: Local Institution
city: Lille
country: France
facility: Local Institution
city: Limoges
country: France
facility: Local Institution
city: Lyon Cedex 04
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: PESSAC Cedex
country: France
facility: Local Institution
city: Toulouse Cedex 09
country: France
facility: Local Institution
city: Vandoeuvre Les Nancy
country: France
facility: Local Institution
city: Dusseldorf
country: Germany
facility: Local Institution
city: Essen
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: Mainz
country: Germany
facility: Local Institution
city: Dublin 3
country: Ireland
facility: Mater Misericordiae University Hospital
state: Dublin
city: Dublin 8
country: Ireland
facility: St. James'S Hospital
state: Dublin
city: Brescia
country: Italy
facility: Local Institution
city: Cisanello (pisa)
country: Italy
facility: Local Institution
city: Milano
country: Italy
facility: Local Institution
city: Pavia
country: Italy
facility: Local Institution
city: Torino
country: Italy
facility: Local Institution
city: Viale Del Policlinico, 155
country: Italy
facility: Local Institution
city: Nagoya-shi
country: Japan
facility: Local Institution
state: Aichi
city: Chiba-shi
country: Japan
facility: Local Institution
state: Chiba
city: Fukuoka-shi
country: Japan
facility: Local Institution
state: Fukuoka
city: Kurume
country: Japan
facility: Local Institution
state: Fukuoka
city: Ogaki-shi
country: Japan
facility: Local Institution
state: Gifu
city: Hiroshima-shi
country: Japan
facility: Local Institution
state: Hiroshima
city: Sapporo-shi
country: Japan
facility: Local Institution
state: Hokkaido
city: Amagasaki-shi
country: Japan
facility: Local Institution
state: Hyogo
city: Kanazawa-shi
country: Japan
facility: Local Institution
state: Ishikawa
city: Takamatsu-shi
country: Japan
facility: Local Institution
state: Kagawa
city: Kagoshima-shi
country: Japan
facility: Local Institution
state: Kagoshima
city: Kawasaki-shi
country: Japan
facility: Local Institution
state: Kanagawa
city: Sendai-shi
country: Japan
facility: Local Institution
state: Miyagi
city: Okayama-shi
country: Japan
facility: Local Institution
state: Okayama
city: Osaka-sayama-shi
country: Japan
facility: Local Institution
state: Osaka
city: Osaka-shi
country: Japan
facility: Local Institution
state: Osaka
city: Suita-shi
country: Japan
facility: Local Institution
state: Osaka
city: Suita
country: Japan
facility: Local Institution
state: Osaka
city: Iruma-gun
country: Japan
facility: Local Institution
state: Saitama
city: Bunkyo-ku
country: Japan
facility: Local Institution
state: Tokyo
city: Minato-ku
country: Japan
facility: Local Institution
state: Tokyo
city: Musashino-shi
country: Japan
facility: Local Institution
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Local Institution
state: Tokyo
city: Chuo-shi
country: Japan
facility: Local Institution
state: Yamanashi
city: Yangsan-si
country: Korea, Republic of
facility: Local Institution
state: Gyeongsangnam-do
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: Guadalajara
country: Mexico
facility: Local Institution
state: Jalisco
city: Cuernavaca
country: Mexico
facility: Local Institution
state: Morelos
city: Monterrey
country: Mexico
facility: Local Institution
state: Nuevo LEON
city: Bialystok
country: Poland
facility: Local Institution
city: San Juan
country: Puerto Rico
facility: Local Institution
city: Alicante
country: Spain
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Malaga
country: Spain
facility: Local Institution
city: Santiago De Compostela
country: Spain
facility: Local Institution
city: Sevilla
country: Spain
facility: Local Institution
city: Valencia
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: London
country: United Kingdom
facility: Kings College Hospital
state: Greater London
city: London
country: United Kingdom
facility: Local Institution
state: Greater London
city: London
country: United Kingdom
facility: Imperial College London
state: Greater London
city: Manchester
country: United Kingdom
facility: North Manchester General Hospital
state: Greater Manchester
city: Glasgow
country: United Kingdom
facility: Gartnaval General Hospital
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Reddy KR, Pol S, Thuluvath PJ, Kumada H, Toyota J, Chayama K, Levin J, Lawitz EJ, Gadano A, Ghesquiere W, Gerken G, Brunetto MR, Peng CY, Silva M, Strasser SI, Heo J, McPhee F, Liu Z, Yang R, Linaberry M, Noviello S. Long-term follow-up of clinical trial patients treated for chronic HCV infection with daclatasvir-based regimens. Liver Int. 2018 May;38(5):821-833. doi: 10.1111/liv.13596. Epub 2017 Oct 12.