Long Term Follow-up Study to Assess Durability of Sustained Virologic Response in Alisporivir-treated Hepatitis C Patients

NCT02753699 | Completed Phase 3 Results

• 2 other identifiers: CDEB025A23122011-006131-38
• Study Type: interventional
• Target: 723
• Locations: 22 countries
• Sites: 119

Brief Summary

The purpose of this study is to follow-up with participants from feeder studies who achieved sustained virologic response (SVR) over 24 hours posttreatment (SVR24), to assess durability of SVR, and to assess the changes in liver disease, development of hepatocellular carcinoma and post-treatment safety over time. 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.

Conditions

Hepatitis C

Keywords

Chronic hepatitis C

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Maintaining Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Load Below the Level of Quantification (LOQ) Through Week 48

  up to 120 Weeks

Secondary Outcomes (1)

• Percentage of Participants With Normal Alanine-aminotransferase (ALT) Values at Week 48.

  at Week 48

Study Arms (3)

From Study 2210

EXPERIMENTAL

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.

Drug: Alisporivir

From Study 2301

EXPERIMENTAL

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.

Drug: Alisporivir

From Study 2211

EXPERIMENTAL

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.

Drug: Alisporivir

Interventions

Alisporivir DRUG

Intervention of interest; follow-up after ALV-active study

Also known as: DEB025, Debio 025, ALV

From Study 2210; From Study 2211; From Study 2301

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provides written informed consent before any assessment is performed
• Is male or female aged ≥18
• Has previously completed a Novartis-sponsored hepatitis C study and received alisporivir
• Has achieved SVR24
• Is able to comply with the visit schedule

You may not qualify if:

• Use of any investigational drugs within 5 half-lives of enrollment, or within 30 days of that medication, whichever is longer.
• Use or planned use to start a new course of hepatitis C therapy.

Sponsors & Collaborators

• Debiopharm International SA: lead

Study Sites (119)

Novartis Investigative Site

La Jolla, California, 92037, United States

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San Diego, California, 92101, United States

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Ventura, California, 93003, United States

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Bradenton, Florida, 34209, United States

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Honolulu, Hawaii, 96814, United States

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Springfield, Illinois, 62703, United States

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Indianapolis, Indiana, 46237, United States

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Arlington, Texas, 76012, United States

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Dallas, Texas, 75246-2096, United States

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Houston, Texas, 77030, United States

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San Antonio, Texas, 78215, United States

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Salt Lake City, Utah, 84124, United States

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Buenos Aires, Buenos Aires, C1125ABE, Argentina

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Buenos Aires, Buenos Aires, C1405BCK, Argentina

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Kingswood, New South Wales, 2747, Australia

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Kogarah, New South Wales, 2217, Australia

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Westmead, New South Wales, 2145, Australia

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Greenslopes, Queensland, 4120, Australia

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Fitzroy, Victoria, 3065, Australia

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Ghent, 9000, Belgium

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Calgary, Alberta, T2N 4N1, Canada

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Vancouver, British Columbia, V5Z 1J4, Canada

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Vancouver, British Columbia, v6z 2k5, Canada

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Torono, Ontario, M5G 2C4, Canada

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Novartis Investigative Site

Clichy, 92110, France

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Créteil, 94010, France

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Lyon, 69317, France

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Nice, 06202, France

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Paris, 75014, France

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Berlin, 10969, Germany

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Cologne, 50937, Germany

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Frankfurt, 60590, Germany

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Freiburg im Breisgau, 79106, Germany

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Hamburg, 20099, Germany

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Hanover, 30625, Germany

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Kiel, 24146, Germany

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Leipzig, 04103, Germany

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Mainz, 55131, Germany

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Hong Kong, Hong Kong, Hong Kong

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Békéscsaba, H-5600, Hungary

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Budapest, 1083, Hungary

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Budapest, 1097, Hungary

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Budapest, 1126, Hungary

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Debrecen, 4032, Hungary

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Kaposvár, 7400, Hungary

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Pécs, 7624, Hungary

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Székesfehérvár, 8000, Hungary

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Hyderabad, Andhra Pradesh, 500012, India

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Mumbai, Maharashtra, 400012, India

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Delhi, National Capital Territory of Delhi, 110070, India

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Ludhiana, Punjab, 141001, India

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Bologna, BO, 40138, Italy

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Brescia, BS, 25123, Italy

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Milan, MI, 20121, Italy

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Milan, MI, 20122, Italy

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Milan, MI, 20162, Italy

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Rozzano, MI, 20089, Italy

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Palermo, PA, 90127, Italy

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Parma, PR, 43100, Italy

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Pavia, PV, 27100, Italy

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Roma, RM, 00133, Italy

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Roma, RM, 00161, Italy

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Torino, TO, 10126, Italy

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Bologna, 40138, Italy

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Napoli, 80135, Italy

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Mexico City, Mexico City, 14000, Mexico

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Monterrey, Nuevo León, 64020, Mexico

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Bialystok, 15-540, Poland

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Bydgoszcz, 85-030, Poland

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Lódz, 91-347, Poland

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Warsaw, 01-201, Poland

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Zawiercie, 42-400, Poland

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Bucharest, 020125, Romania

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Bucharest, 021105, Romania

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Bucharest, 030317, Romania

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Bucharest, 050524, Romania

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Craiova, 200515, Romania

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Iași, 700506, Romania

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Iași, Romania

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Moscow, 111123, Russia

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Saint Petersburg, 197376, Russia

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Busan, Busan, 602-739, South Korea

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Seongnam-si, Gyeonggi-do, 463-712, South Korea

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Yangsan, Gyeongsangnam-do, 626-770, South Korea

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Seoul, Korea, 03722, South Korea

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Busan, 602-715, South Korea

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Incheon, 22332, South Korea

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Pusan, 614-735, South Korea

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Seville, Andalusia, 41014, Spain

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Barcelona, Catalonia, 08003, Spain

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Barcelona, Catalonia, 08035, Spain

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Majadahonda, Madrid, 28222, Spain

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Valencia, Valencia, 46014, Spain

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Chiayi City, Taiwan, 600, Taiwan

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Douliu, 640, Taiwan

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Kaohsiung City, 807, Taiwan

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Keelung, 20401, Taiwan

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Linkou District, 33305, Taiwan

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Niaosong Township, 83301, Taiwan

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Taichung, 40447, Taiwan

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Taipei, 10002, Taiwan

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Taipei, 112, Taiwan

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Bangkok, 10700, Thailand

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Chiang Mai, 50200, Thailand

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Khon Kaen, 40002, Thailand

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Songkhla, 90110, Thailand

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Fatih / Istanbul, 34098, Turkey (Türkiye)

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Izmir, 35040, Turkey (Türkiye)

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Birmingham, B15 2TT, United Kingdom

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Glasgow - Scotland, G12 OYN, United Kingdom

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London, E1 1BB, United Kingdom

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London, SE5 9RS, United Kingdom

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London, SW17 0QT, United Kingdom

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Newcastle upon Tyne, NE7 7DN, United Kingdom

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Nottingham, NG7 2UH, United Kingdom

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Plymouth, PL6 8DH, United Kingdom

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Hanoi, 100000, Vietnam

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Hanoi, Vietnam

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Ho Chi Minh City, Vietnam

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MeSH Terms

Conditions

Hepatitis C; Hepatitis C, Chronic

Interventions

alisporivir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Hepatitis, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Vice President Clinical Research & Development
• Organization: Debiopharm International, S.A.

info-international@debiopharm.com

4121 321 01 11

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2016
• First Posted: April 28, 2016
• Study Start: December 1, 2011
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: August 26, 2016
• Results First Posted: August 26, 2016

Record last verified: 2016-07

Locations

ES (5); AU (5); PL (5); RO (7); IT (14); ME (2); HK (1); GB (8); DE (9); HU (8); TW (9); BE (1); AR (2); US (12); FR (5); KR (7); TH (4); RU (2); TU (2); CA (4); IN (4); VN (3)