--- title: 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 nct_id: NCT01492504 overall_status: COMPLETED sponsor: Bristol-Myers Squibb study_type: OBSERVATIONAL primary_condition: Hepatitis C countries: United States, Argentina, Australia, Brazil, Canada, Denmark, France, Germany, Ireland, Italy, Japan, Mexico, Poland, Puerto Rico, South Korea, Spain, Sweden, Taiwan, United Kingdom canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01492504.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01492504" ct_last_update_post_date: 2019-11-27 last_seen_at: "2026-05-12T07:28:50.285Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # 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 **NCT ID:** [NCT01492504](https://clinicaltrials.gov/study/NCT01492504) ## Key Facts - **Status:** COMPLETED - **Study Type:** OBSERVATIONAL - **Target Enrollment:** 1850 - **Lead Sponsor:** Bristol-Myers Squibb - **Conditions:** Hepatitis C - **Start Date:** 2012-02-07 - **Completion Date:** 2018-03-19 - **CT.gov Last Update:** 2019-11-27 ## 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 - **Minimum age:** 18 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` 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 ``` ## Arms - **Subjects with chronic hepatitis C** — 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 ## Interventions - **Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052)** (DRUG) — Observational study - No Intervention \[(subjects were previously treated with Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052)\] ## Primary Outcomes - **Durability of Sustained viral response [SVR] (time to loss of virologic response)** _(time frame: 24 or 48-week Intervals)_ — 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) ## Secondary Outcomes - **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** _(time frame: 24 or 48-week intervals)_ - **Long-term progression of liver disease, as measured by the frequency of hepatic disease progression, all cause mortality, and liver-related mortality** _(time frame: 24 or 48-week intervals)_ ## Locations (161) - Alabama Liver & Digestive Specialists (Alds), Montgomery, Alabama, United States - Pacific Oaks Medical Group, Beverly Hills, California, United States - Southern California Research Center, Coronado, California, United States - Scripps Clinic, La Jolla, 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 - Anthony M. Mills Md Inc, Los Angeles, California, United States - Precision Research Institute, Llc, San Diego, California, United States - Quest Clinical Research, San Diego, California, United States - Medical Associates Research Group, San Diego, California, United States - U.Cal.-San Francisco, San Francisco, California, United States - University Of Colorado Denver & Hospital, Aurora, Colorado, United States - Yale New Haven Hospital, New Haven, Connecticut, United States - Schiff Center for Liver Diseases, Miami, Florida, United States - University Of Miami School Of Medicine, Miami, Florida, United States - Orlando Immunology Center, Orlando, Florida, United States - Florida Hospital Transplant Center, Orlando, Florida, United States - Gastrointestinal Specialists Of Georgia, Marietta, Georgia, United States - Ruth M. Rothstein CORE Center, Chicago, Illinois, United States - Indiana University, Indianapolis, Indiana, United States - Mercy Medical Center, Baltimore, Maryland, United States - Digestive Disease Associates, P.A., Catonsville, Maryland, United States - Johns Hopkins University, Lutherville, Maryland, United States - The Research Institute, Springfield, Massachusetts, United States - University Of Michigan, Ann Arbor, Michigan, United States - Saint Louis University, St Louis, Missouri, United States - Southwest Care Center, Santa Fe, New Mexico, United States - Nyu Medical Center, Great Neck, New York, 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 - Carolinas Center For Liver Disease, Statesville, North Carolina, United States - Mayo Clinic Rochester, Tulsa, Oklahoma, United States - Healthcare Research Consultants, Tulsa, Oklahoma, United States - Oregon Health & Science University, Portland, Oregon, United States - Lehigh Valley Health Network, Allentown, Pennsylvania, United States - University Of Pennsylvania School Of Medicine, Philadelphia, Pennsylvania, United States - Gastro One, Germantown, Tennessee, United States - Nashville Medical Research Institute, Nashville, Tennessee, United States - Texas Clinical Research Institute, Arlington, Texas, United States - Baylor College Of Medicine, Houston, Texas, United States - Liver Associates Of Texas, Houston, Texas, United States - MEDVAMC, Houston, Texas, United States - Alamo Medical Research, San Antonio, Texas, United States - Lifetree Clinical Research, Salt Lake City, Utah, United States - Metropolitan Research, Annandale, Virginia, United States - Inova Fairfax Hospital, Falls Church, Virginia, United States - Bon Secours St. Mary's Hospital of Richmond, Inc., Richmond, Virginia, United States - Mcguire Dvamc, Richmond, Virginia, United States - Harborview Medical Center, Seattle, Washington, United States - Ssm Health Dean Med Group, Madison, Wisconsin, United States - Fundacion Cidea De Paraguay, Ciudad de Buenos Aires, Buenos Aires, Argentina - Centro Oncologico Integral, Mar del Plata, Buenos Aires, Argentina - Hospital Austral, Prov. Buenos Aires, Buenos Aires, Argentina - Instituto Centralizado De Asistencia E Investigacion Clinica, Prov de Santa Fe, Santa Fe Province, Argentina - Local Institution, Buenos Aires, Argentina - Hospital Italiano De Buenos Aires, Buenos Aires, Argentina - Local Institution, Camperdown, New South Wales, Australia - Local Institution, Darlinghurst, New South Wales, Australia - Local Institution, Darlinghurst Nsw, New South Wales, Australia - Local Institution, Randwick, New South Wales, Australia - Local Institution, Westmead, New South Wales, Australia - Local Institution, Woollongabba, Queensland, Australia - Local Institution, Adelaide, South Australia, Australia - Local Institution, Clayton Vic, Victoria, Australia - Local Institution, Melbourne, Victoria, Australia - Local Institution, Porto Alegre, Rio Grande do Sul, Brazil - Local Institution, Rio de Janeiro, Brazil - Local Institution, Rio de Janeiro, Brazil - Local Institution, São Paulo, Brazil - Local Institution, Calgary, Alberta, Canada - Local Institution, Edmonton, Alberta, Canada - Local Institution, Vancouver, British Columbia, Canada - Local Institution, Vancouver, British Columbia, Canada - Local Institution, Victoria, British Columbia, Canada - Local Institution, Toronto, Ontario, Canada - Toronto General Hospital, Toronto, Ontario, Canada - Local Institution, Regina, Saskatchewan, Canada - Local Institution, Hvidovre, Denmark - Local Institution, Odense, Denmark - Local Institution, Clichy, France - Local Institution, Créteil, France - Local Institution, La Roche-sur-Yon, France - Local Institution, Lille, France - Local Institution, Limoges, France - Local Institution, Lyon, France - Local Institution, Marseille, France - Local Institution, Montpellier, France - Local Institution, Nice, France - Local Institution, Paris, France - Local Institution, Paris, France - Local Institution, Paris, France - Local Institution, Pessac, France - Local Institution, Toulouse, France - Local Institution, Vandœuvre-lès-Nancy, France - Local Institution, Düsseldorf, Germany - Local Institution, Essen, Germany - Local Institution, Frankfurt, Germany - Local Institution, Hamburg, Germany - Local Institution, Hanover, Germany - Local Institution, Heidelberg, Germany - Local Institution, Mainz, Germany - Mater Misericordiae University Hospital, Dublin, Dublin, Ireland - St. James'S Hospital, Dublin, Dublin, Ireland - Local Institution, Brescia, Italy - Local Institution, Cisanello (pisa), Italy - Local Institution, Milan, Italy - Local Institution, Pavia, Italy - Local Institution, Torino, Italy - Local Institution, Viale Del Policlinico, 155, Italy - Local Institution, Nagoya, Aichi-ken, Japan - Local Institution, Chiba, Chiba, Japan - Local Institution, Fukuoka, Fukuoka, Japan - Local Institution, Kurume, Fukuoka, Japan - Local Institution, Ogaki-shi, Gifu, Japan - Local Institution, Hiroshima, Hiroshima, Japan - Local Institution, Sapporo, Hokkaido, Japan - Local Institution, Amagasaki-shi, Hyōgo, Japan - Local Institution, Kanazawa, Ishikawa-ken, Japan - Local Institution, Takamatsu, Kagawa-ken, Japan - Local Institution, Kagoshima, Kagoshima-ken, Japan - Local Institution, Kawasaki-shi, Kanagawa, Japan - Local Institution, Sendai, Miyagi, Japan - Local Institution, Okayama, Okayama-ken, Japan - Local Institution, Osaka, Osaka, Japan - Local Institution, Osaka-sayama-shi, Osaka, Japan - Local Institution, Suita, Osaka, Japan - Local Institution, Suita-shi, Osaka, Japan - Local Institution, Iruma-gun, Saitama, Japan - Local Institution, Bunkyo-ku, Tokyo, Japan - Local Institution, Minato-ku, Tokyo, Japan - Local Institution, Musashino-shi, Tokyo, Japan - Local Institution, Shinagawa-ku, Tokyo, Japan - Local Institution, Chuo-shi, Yamanashi, Japan - Local Institution, Guadalajara, Jalisco, Mexico - Local Institution, Cuernavaca, Morelos, Mexico - Local Institution, Monterrey, Nuevo León, Mexico - Local Institution, Bialystok, Poland - Local Institution, San Juan, Puerto Rico - Local Institution, Yangsan, Gyeongsangnam-do, South Korea - Local Institution, Busan, South Korea - Local Institution, Busan, South Korea - Local Institution, Busan, South Korea - 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, Málaga, Spain - Local Institution, Santiago de Compostela, Spain - Local Institution, Seville, Spain - Local Institution, Valencia, Spain - Local Institution, Gothenburg, Sweden - Local Institution, Stockholm, Sweden - Local Institution, Taichung, Taiwan - Kings College Hospital, London, Greater London, United Kingdom - Local Institution, London, Greater London, United Kingdom - Imperial College London, London, Greater London, United Kingdom - North Manchester General Hospital, Manchester, Greater Manchester, United Kingdom - Gartnaval General Hospital, Glasgow, United Kingdom ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.alabama liver & digestive specialists (alds)|montgomery|alabama|united states` — added _(2026-05-12)_ - `locations.pacific oaks medical group|beverly hills|california|united states` — added _(2026-05-12)_ - `locations.southern california research center|coronado|california|united states` — added _(2026-05-12)_ - `locations.scripps clinic|la jolla|california|united states` — added _(2026-05-12)_ - `locations.keck medical center of usc, hcc 1|los angeles|california|united states` — added _(2026-05-12)_ - `locations.peter j ruane md inc|los angeles|california|united states` — added _(2026-05-12)_ - `locations.anthony m. mills md inc|los angeles|california|united states` — added _(2026-05-12)_ - `locations.precision research institute, llc|san diego|california|united states` — added _(2026-05-12)_ - `locations.quest clinical research|san diego|california|united states` — added _(2026-05-12)_ - `locations.medical associates research group|san diego|california|united states` — added _(2026-05-12)_ - `locations.u.cal.-san francisco|san francisco|california|united states` — added _(2026-05-12)_ - `locations.university of colorado denver & hospital|aurora|colorado|united states` — added _(2026-05-12)_ - `locations.yale new haven hospital|new haven|connecticut|united states` — added _(2026-05-12)_ - `locations.schiff center for liver diseases|miami|florida|united states` — added _(2026-05-12)_ - `locations.university of miami school of medicine|miami|florida|united states` — added _(2026-05-12)_ - `locations.orlando immunology center|orlando|florida|united states` — added _(2026-05-12)_ - `locations.florida hospital transplant center|orlando|florida|united states` — added _(2026-05-12)_ - `locations.gastrointestinal specialists of georgia|marietta|georgia|united states` — added _(2026-05-12)_ - `locations.ruth m. rothstein core center|chicago|illinois|united states` — added _(2026-05-12)_ - `locations.indiana university|indianapolis|indiana|united states` — added _(2026-05-12)_ - `locations.mercy medical center|baltimore|maryland|united states` — added _(2026-05-12)_ - `locations.digestive disease associates, p.a.|catonsville|maryland|united states` — added _(2026-05-12)_ - `locations.johns hopkins university|lutherville|maryland|united states` — added _(2026-05-12)_ - `locations.the research institute|springfield|massachusetts|united states` — added _(2026-05-12)_ - `locations.university of michigan|ann arbor|michigan|united states` — added _(2026-05-12)_ - `locations.saint louis university|st louis|missouri|united states` — added _(2026-05-12)_ - `locations.southwest care center|santa fe|new mexico|united states` — added _(2026-05-12)_ - `locations.nyu medical center|great neck|new york|united states` — added _(2026-05-12)_ - `locations.university of north carolina at chapel hill school of med|chapel hill|north carolina|united states` — added _(2026-05-12)_ - `locations.carolinas medical center|charlotte|north carolina|united states` — added _(2026-05-12)_ - `locations.carolinas center for liver disease|statesville|north carolina|united states` — added _(2026-05-12)_ - `locations.mayo clinic rochester|tulsa|oklahoma|united states` — added _(2026-05-12)_ - `locations.healthcare research consultants|tulsa|oklahoma|united states` — added _(2026-05-12)_ - `locations.oregon health & science university|portland|oregon|united states` — added _(2026-05-12)_ - `locations.lehigh valley health network|allentown|pennsylvania|united states` — added _(2026-05-12)_ - `locations.university of pennsylvania school of medicine|philadelphia|pennsylvania|united states` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT01492504.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT01492504* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*