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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01492504
• Other study ID #: AI444-046
• Secondary ID: 2011-005287-21
• Status: Completed
• Start date: February 7, 2012
• Est. completion date: March 19, 2018

Study information

• Verified date: November 2019
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1850
• Est. completion date: March 19, 2018
• Est. primary completion date: March 16, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic

Intervention

Drug:
• Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052)
Observational study - No Intervention [(subjects were previously treated with Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052)]

Locations

Country	Name	City	State
Argentina	Hospital Italiano De Buenos Aires	Buenos Aires
Argentina	Local Institution	Buenos Aires
Argentina	Fundacion Cidea De Paraguay	Ciudad De Buenos Aires	Buenos Aires
Argentina	Centro Oncologico Integral	Mar Del Plata	Buenos Aires
Argentina	Instituto Centralizado De Asistencia E Investigacion Clinica	Prov De Santa Fe	Santa FE
Argentina	Hospital Austral	Prov. Buenos Aires	Buenos Aires
Australia	Local Institution	Adelaide	South Australia
Australia	Local Institution	Camperdown	New South Wales
Australia	Local Institution	Clayton Vic	Victoria
Australia	Local Institution	Darlinghurst	New South Wales
Australia	Local Institution	Darlinghurst Nsw	New South Wales
Australia	Local Institution	Melbourne	Victoria
Australia	Local Institution	Randwick	New South Wales
Australia	Local Institution	Westmead	New South Wales
Australia	Local Institution	Woollongabba	Queensland
Brazil	Local Institution	Porto Alegre	RIO Grande DO SUL
Brazil	Local Institution	Rio De Janeiro
Brazil	Local Institution	Rio De Janeiro
Brazil	Local Institution	Sao Paulo
Canada	Local Institution	Calgary	Alberta
Canada	Local Institution	Edmonton	Alberta
Canada	Local Institution	Regina	Saskatchewan
Canada	Local Institution	Toronto	Ontario
Canada	Toronto General Hospital	Toronto	Ontario
Canada	Local Institution	Vancouver	British Columbia
Canada	Local Institution	Vancouver	British Columbia
Canada	Local Institution	Victoria	British Columbia
Denmark	Local Institution	Hvidovre
Denmark	Local Institution	Odense
France	Local Institution	Clichy Cedex
France	Local Institution	Creteil Cedex
France	Local Institution	La Roche-sur-yon Cedex 9
France	Local Institution	Lille
France	Local Institution	Limoges
France	Local Institution	Lyon Cedex 04
France	Local Institution	Marseille Cedex 08
France	Local Institution	Montpellier Cedex 5
France	Local Institution	Nice Cedex 03
France	Local Institution	Paris Cedex 12
France	Local Institution	Paris Cedex 13
France	Local Institution	Paris Cedex 14
France	Local Institution	PESSAC Cedex
France	Local Institution	Toulouse Cedex 09
France	Local Institution	Vandoeuvre Les Nancy
Germany	Local Institution	Dusseldorf
Germany	Local Institution	Essen
Germany	Local Institution	Frankfurt
Germany	Local Institution	Hamburg
Germany	Local Institution	Hannover
Germany	Local Institution	Heidelberg
Germany	Local Institution	Mainz
Ireland	Mater Misericordiae University Hospital	Dublin 3	Dublin
Ireland	St. James'S Hospital	Dublin 8	Dublin
Italy	Local Institution	Brescia
Italy	Local Institution	Cisanello (pisa)
Italy	Local Institution	Milano
Italy	Local Institution	Pavia
Italy	Local Institution	Torino
Italy	Local Institution	Viale Del Policlinico, 155
Japan	Local Institution	Amagasaki-shi	Hyogo
Japan	Local Institution	Bunkyo-ku	Tokyo
Japan	Local Institution	Chiba-shi	Chiba
Japan	Local Institution	Chuo-shi	Yamanashi
Japan	Local Institution	Fukuoka-shi	Fukuoka
Japan	Local Institution	Hiroshima-shi	Hiroshima
Japan	Local Institution	Iruma-gun	Saitama
Japan	Local Institution	Kagoshima-shi	Kagoshima
Japan	Local Institution	Kanazawa-shi	Ishikawa
Japan	Local Institution	Kawasaki-shi	Kanagawa
Japan	Local Institution	Kurume	Fukuoka
Japan	Local Institution	Minato-ku	Tokyo
Japan	Local Institution	Musashino-shi	Tokyo
Japan	Local Institution	Nagoya-shi	Aichi
Japan	Local Institution	Ogaki-shi	Gifu
Japan	Local Institution	Okayama-shi	Okayama
Japan	Local Institution	Osaka-sayama-shi	Osaka
Japan	Local Institution	Osaka-shi	Osaka
Japan	Local Institution	Sapporo-shi	Hokkaido
Japan	Local Institution	Sendai-shi	Miyagi
Japan	Local Institution	Shinagawa-ku	Tokyo
Japan	Local Institution	Suita	Osaka
Japan	Local Institution	Suita-shi	Osaka
Japan	Local Institution	Takamatsu-shi	Kagawa
Korea, Republic of	Local Institution	Busan
Korea, Republic of	Local Institution	Busan
Korea, Republic of	Local Institution	Busan
Korea, Republic of	Local Institution	Yangsan-si	Gyeongsangnam-do
Mexico	Local Institution	Cuernavaca	Morelos
Mexico	Local Institution	Guadalajara	Jalisco
Mexico	Local Institution	Monterrey	Nuevo LEON
Poland	Local Institution	Bialystok
Puerto Rico	Local Institution	San Juan
Spain	Local Institution	Alicante
Spain	Local Institution	Barcelona
Spain	Local Institution	Barcelona
Spain	Local Institution	Madrid
Spain	Local Institution	Madrid
Spain	Local Institution	Madrid
Spain	Local Institution	Madrid
Spain	Local Institution	Malaga
Spain	Local Institution	Santiago De Compostela
Spain	Local Institution	Sevilla
Spain	Local Institution	Valencia
Sweden	Local Institution	Gothenburg
Sweden	Local Institution	Stockholm
Taiwan	Local Institution	Taichung
United Kingdom	Gartnaval General Hospital	Glasgow
United Kingdom	Imperial College London	London	Greater London
United Kingdom	Kings College Hospital	London	Greater London
United Kingdom	Local Institution	London	Greater London
United Kingdom	North Manchester General Hospital	Manchester	Greater Manchester
United States	Lehigh Valley Health Network	Allentown	Pennsylvania
United States	University Of Michigan	Ann Arbor	Michigan
United States	Metropolitan Research	Annandale	Virginia
United States	Texas Clinical Research Institute	Arlington	Texas
United States	University Of Colorado Denver & Hospital	Aurora	Colorado
United States	Mercy Medical Center	Baltimore	Maryland
United States	Pacific Oaks Medical Group	Beverly Hills	California
United States	Digestive Disease Associates, P.A.	Catonsville	Maryland
United States	University Of North Carolina At Chapel Hill School Of Med	Chapel Hill	North Carolina
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	Ruth M. Rothstein CORE Center	Chicago	Illinois
United States	Southern California Research Center	Coronado	California
United States	Inova Fairfax Hospital	Falls Church	Virginia
United States	Gastro One	Germantown	Tennessee
United States	Nyu Medical Center	Great Neck	New York
United States	Baylor College Of Medicine	Houston	Texas
United States	Liver Associates Of Texas	Houston	Texas
United States	MEDVAMC	Houston	Texas
United States	Indiana University	Indianapolis	Indiana
United States	Scripps Clinic	La Jolla	California
United States	Anthony M. Mills Md Inc	Los Angeles	California
United States	Keck Medical Center of USC, HCC 1	Los Angeles	California
United States	Peter J Ruane Md Inc	Los Angeles	California
United States	Johns Hopkins University	Lutherville	Maryland
United States	Ssm Health Dean Med Group	Madison	Wisconsin
United States	Gastrointestinal Specialists Of Georgia	Marietta	Georgia
United States	Schiff Center for Liver Diseases	Miami	Florida
United States	University Of Miami School Of Medicine	Miami	Florida
United States	Alabama Liver & Digestive Specialists (Alds)	Montgomery	Alabama
United States	Nashville Medical Research Institute	Nashville	Tennessee
United States	Yale New Haven Hospital	New Haven	Connecticut
United States	Florida Hospital Transplant Center	Orlando	Florida
United States	Orlando Immunology Center	Orlando	Florida
United States	University Of Pennsylvania School Of Medicine	Philadelphia	Pennsylvania
United States	Oregon Health & Science University	Portland	Oregon
United States	Bon Secours St. Mary's Hospital of Richmond, Inc.	Richmond	Virginia
United States	Mcguire Dvamc	Richmond	Virginia
United States	Saint Louis University	Saint Louis	Missouri
United States	Lifetree Clinical Research	Salt Lake City	Utah
United States	Alamo Medical Research	San Antonio	Texas
United States	Medical Associates Research Group	San Diego	California
United States	Precision Research Institute, Llc	San Diego	California
United States	Quest Clinical Research	San Diego	California
United States	U.Cal.-San Francisco	San Francisco	California
United States	Southwest Care Center	Santa Fe	New Mexico
United States	Harborview Medical Center	Seattle	Washington
United States	The Research Institute	Springfield	Massachusetts
United States	Carolinas Center For Liver Disease	Statesville	North Carolina
United States	Healthcare Research Consultants	Tulsa	Oklahoma
United States	Mayo Clinic Rochester	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Brazil,  Canada,  Denmark,  France,  Germany,  Ireland,  Italy,  Japan,  Korea, Republic of,  Mexico,  Poland,  Puerto Rico,  Spain,  Sweden,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Durability of Sustained viral response [SVR] (time to loss of virologic response)	The durability of virologic response, as assessed by the time to loss of virologic response after achieving sustained viral response (SVR12) in a previous study with Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052). Loss of virologic response assessed using Hepatitis C virus (HCV) Ribonucleic acid (RNA)	24 or 48-week Intervals
Secondary	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		24 or 48-week intervals
Secondary	Long-term progression of liver disease, as measured by the frequency of hepatic disease progression, all cause mortality, and liver-related mortality		24 or 48-week intervals

External Links

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