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

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ClinicalTrials.gov Identifier: NCT02753699
Recruitment Status : Completed
First Posted : April 28, 2016
Results First Posted : August 26, 2016
Last Update Posted : August 26, 2016
Sponsor:
Information provided by (Responsible Party):
Debiopharm International SA

Study Description
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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.


Condition or disease Intervention/treatment Phase
Hepatitis C Drug: Alisporivir Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 723 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: A Multi-centre Long Term Follow-up Study to Assess the Durability of Sustained Virologic Response in Alisporivir-treated Chronic Hepatitis C Patients
Study Start Date : December 2011
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 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.
 Drug: Alisporivir
Intervention of interest; follow-up after ALV-active study
Other Names:
  • DEB025
  • Debio 025
  • ALV
Experimental: 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.
 Drug: Alisporivir
Intervention of interest; follow-up after ALV-active study
Other Names:
  • DEB025
  • Debio 025
  • ALV
Experimental: 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.
 Drug: Alisporivir
Intervention of interest; follow-up after ALV-active study
Other Names:
  • DEB025
  • Debio 025
  • ALV


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants Maintaining Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Load Below the Level of Quantification (LOQ) Through Week 48 [ Time Frame: up to 120 Weeks ]

Secondary Outcome Measures :
  1. Percentage of Participants With Normal Alanine-aminotransferase (ALT) Values at Week 48. [ Time Frame: at Week 48 ]
    Note that the 24-week period between end of feeder study (SVR24) and first visit in this follow-up study is not counted in the 48 weeks, so this timepoint corresponds to 96 weeks (=24+24+48) after the last dose of alisporivir.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Provides written informed consent before any assessment is performed
  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:

  1. Use of any investigational drugs within 5 half-lives of enrollment, or within 30 days of that medication, whichever is longer.
  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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02753699


Locations
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Sponsors and Collaborators
Debiopharm International SA
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Responsible Party: Debiopharm International SA
ClinicalTrials.gov Identifier: NCT02753699    
Other Study ID Numbers: CDEB025A2312
2011-006131-38 ( EudraCT Number )
First Posted: April 28, 2016    Key Record Dates
Results First Posted: August 26, 2016
Last Update Posted: August 26, 2016
Last Verified: July 2016
Keywords provided by Debiopharm International SA:
Chronic hepatitis C
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
 Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Blood-Borne Infections
Communicable Diseases
Flaviviridae Infections