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3-year Follow-up Study to Assess the Viral Activity in Hepatitis C Patients Who Failed Feeder DEB025/Alisporivir Study

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ClinicalTrials.gov Identifier: NCT02465203
Recruitment Status : Terminated (Study was prematurely terminated.)
First Posted : June 8, 2015
Results First Posted : January 12, 2018
Last Update Posted : January 12, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
Follow-up for viral activity, changes in liver function and safety in patients with no SVR24 in feeder studies

Condition or disease Intervention/treatment Phase
Hepatitis C, Chronic Drug: Previous treatment in DEB025 study Phase 3

Detailed Description:
The purpose of this study was to follow patients from the feeder studies who have not achieved SVR24 to assess their viral activity, and to assess the changes in liver function and disease, and post-treatment safety over time.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Multi-centre 3-year Follow-up Study to Assess the Viral Activity in Patients Who Failed to Achieve Sustained Virologic Response in Novartis-sponsored Alisporivir-studies for Chronic Hepatitis C Patients
Actual Study Start Date : September 6, 2012
Actual Primary Completion Date : January 23, 2014
Actual Study Completion Date : January 23, 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Follow up from feeder studies
Follow up arm
Drug: Previous treatment in DEB025 study
Follow-up after DEB025 active study
Other Name: Data was not collected




Primary Outcome Measures :
  1. HCV RNA Sequencing [ Time Frame: 27 months ]
    Persistence of resistance associated variants


Secondary Outcome Measures :
  1. Safety Parameters as Measured by HCV RNA Sequencing [ Time Frame: 27 months ]
    Phenotypic analysis of HCV isolates to determine the patients susceptibility/resistance to alisporivir in vitro

  2. Safety Parameters as Measured by FibroScan/Fibrotest and Lab Parameters [ Time Frame: 27 months ]
    Changes in liver function and disease over time

  3. Safety Parameters as Measured by Liver UltraSound and Lab Parameters [ Time Frame: 27 months ]
    Development of hepatocellular carcinoma (HCC)

  4. Safety Parameters [ Time Frame: 27 months ]
    Safety over time of previous alisporivir exposure



Information from the National Library of Medicine

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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. Males or females aged ≥18
  2. Have previously completed a Novartis-sponsored hepatitis C study and received alisporivir or a direct antiviral agent (DAA)
  3. Have not achieved SVR24

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. Previous use of any course of hepatitis C therapy since the end of the Novartis-sponsored hepatitis C study

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): NCT02465203


  Show 40 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02465203     History of Changes
Other Study ID Numbers: CDEB025A2313
2011-006132-24
First Posted: June 8, 2015    Key Record Dates
Results First Posted: January 12, 2018
Last Update Posted: January 12, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: terminated

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Hepatitis C, chronic

Additional relevant MeSH terms:
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Hepatitis
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Viral, Human
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections