Long Term Follow-up Study to Assess Durability of Sustained Virologic Response in Alisporivir-treated Hepatitis C Patients
NCT ID: NCT02753699
Last Updated: 2016-08-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
723 participants
INTERVENTIONAL
2011-12-31
2015-05-31
Brief Summary
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Participants enter this study from feeder studies CDEB025A2210 (NCT01183169), CDEB025A2301 (NCT01318694), and CDEB025A2211 (NCT01215643). They return to the site for up to 48 weeks with a maximum of 3 visits. No treatment is involved.
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An Observational Study on Long-Term Persistence of Resistant Mutations And Durability of Sustained Virological Response in Patients With Chronic Hepatitis C Treated With Direct Acting Antiviral (DAA)- Containing Regimens
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
NONE
Study Groups
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From Study 2210
All participants enrolled from CDEB025A2210 (n=164) who had been treated with alisporivir during the feeder study. There was no investigational treatment given to participants while enrolled in this follow-up study.
Alisporivir
Intervention of interest; follow-up after ALV-active study
From Study 2301
All participants enrolled from CDEB025A2301 (n=397) who had been treated with alisporivir during the feeder study. There was no investigational treatment given to participants while enrolled in this follow-up study.
Alisporivir
Intervention of interest; follow-up after ALV-active study
From Study 2211
All participants enrolled from CDEB025A2211 (n=162) who had been treated with alisporivir during the feeder study. There was no investigational treatment given to participants while enrolled in this follow-up study.
Alisporivir
Intervention of interest; follow-up after ALV-active study
Interventions
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Alisporivir
Intervention of interest; follow-up after ALV-active study
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Is male or female aged ≥18
3. Has previously completed a Novartis-sponsored hepatitis C study and received alisporivir
4. Has achieved SVR24
5. Is able to comply with the visit schedule
Exclusion Criteria
2. Use or planned use to start a new course of hepatitis C therapy.
3. No additional exclusions are to be applied by the Investigator, in order to ensure that the study population is representative of all eligible patients.
18 Years
ALL
No
Sponsors
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Debiopharm International SA
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
La Jolla, California, United States
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San Diego, California, United States
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Ventura, California, United States
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Bradenton, Florida, United States
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Honolulu, Hawaii, United States
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Springfield, Illinois, United States
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Indianapolis, Indiana, United States
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Arlington, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Salt Lake City, Utah, United States
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Buenos Aires, Buenos Aires, Argentina
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Buenos Aires, Buenos Aires, Argentina
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Kingswood, New South Wales, Australia
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Kogarah, New South Wales, Australia
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Westmead, New South Wales, Australia
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Greenslopes, Queensland, Australia
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Fitzroy, Victoria, Australia
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Ghent, , Belgium
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Calgary, Alberta, Canada
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Vancouver, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Torono, Ontario, Canada
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Clichy, , France
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Créteil, , France
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Lyon, , France
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Nice, , France
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Paris, , France
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Berlin, , Germany
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Cologne, , Germany
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Frankfurt, , Germany
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Freiburg im Breisgau, , Germany
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Hamburg, , Germany
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Hanover, , Germany
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Kiel, , Germany
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Leipzig, , Germany
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Mainz, , Germany
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Hong Kong, Hong Kong, Hong Kong
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Békéscsaba, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Budapest, , Hungary
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Debrecen, , Hungary
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Kaposvár, , Hungary
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Pécs, , Hungary
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Székesfehérvár, , Hungary
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Hyderabad, Andhra Pradesh, India
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Mumbai, Maharashtra, India
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Delhi, National Capital Territory of Delhi, India
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Ludhiana, Punjab, India
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Bologna, BO, Italy
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Brescia, BS, Italy
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Milan, MI, Italy
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Milan, MI, Italy
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Milan, MI, Italy
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Rozzano, MI, Italy
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Palermo, PA, Italy
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Parma, PR, Italy
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Pavia, PV, Italy
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Roma, RM, Italy
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Roma, RM, Italy
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Torino, TO, Italy
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Bologna, , Italy
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Napoli, , Italy
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Mexico City, Mexico City, Mexico
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Monterrey, Nuevo León, Mexico
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Bialystok, , Poland
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Bydgoszcz, , Poland
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Lódz, , Poland
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Warsaw, , Poland
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Zawiercie, , Poland
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Bucharest, , Romania
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Bucharest, , Romania
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Bucharest, , Romania
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Bucharest, , Romania
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Craiova, , Romania
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Iași, , Romania
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Iași, , Romania
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Moscow, , Russia
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Saint Petersburg, , Russia
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Busan, Busan, South Korea
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Seongnam-si, Gyeonggi-do, South Korea
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Yangsan, Gyeongsangnam-do, South Korea
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Seoul, Korea, South Korea
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Busan, , South Korea
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Incheon, , South Korea
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Pusan, , South Korea
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Seville, Andalusia, Spain
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Barcelona, Catalonia, Spain
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Barcelona, Catalonia, Spain
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Majadahonda, Madrid, Spain
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Valencia, Valencia, Spain
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Chiayi City, Taiwan, Taiwan
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Douliu, , Taiwan
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Kaohsiung City, , Taiwan
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Keelung, , Taiwan
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Linkou District, , Taiwan
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Niaosong Township, , Taiwan
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Taichung, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Bangkok, , Thailand
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Chiang Mai, , Thailand
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Khon Kaen, , Thailand
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Songkhla, , Thailand
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Fatih / Istanbul, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Birmingham, , United Kingdom
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Glasgow - Scotland, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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Newcastle upon Tyne, , United Kingdom
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Nottingham, , United Kingdom
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Plymouth, , United Kingdom
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Hanoi, , Vietnam
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Hanoi, , Vietnam
Novartis Investigative Site
Ho Chi Minh City, , Vietnam
Countries
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Other Identifiers
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2011-006131-38
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CDEB025A2312
Identifier Type: -
Identifier Source: org_study_id
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