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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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 )

Study Description
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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.
Study Design
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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


Arms and Interventions
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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


Outcome Measures
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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


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. 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
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): NCT02465203


Locations
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United States, California
Novartis Investigative Site
San Diego, California, United States, 92101
Novartis Investigative Site
Ventura, California, United States, 93003
United States, Hawaii
Novartis Investigative Site
Honolulu, Hawaii, United States, 96814
United States, Illinois
Novartis Investigative Site
Springfield, Illinois, United States, 62703
United States, Texas
Novartis Investigative Site
Arlington, Texas, United States, 76012
Novartis Investigative Site
Houston, Texas, United States, 77030
Novartis Investigative Site
San Antonio, Texas, United States, 78215
Australia, New South Wales
Novartis Investigative Site
Westmead, New South Wales, Australia, 2145
Belgium
Novartis Investigative Site
Leuven, Belgium, 3000
Canada, Ontario
Novartis Investigative Site
Torono, Ontario, Canada, M5G 2C4
Germany
Novartis Investigative Site
Koeln, Nordrhein-Westfalen, Germany, 50937
Novartis Investigative Site
Berlin, Germany, 13353
Novartis Investigative Site
Freiburg, Germany, 79106
Novartis Investigative Site
Hamburg, Germany, 20099
Novartis Investigative Site
Hannover, Germany, 30625
Novartis Investigative Site
Kiel, Germany, 24146
Hungary
Novartis Investigative Site
Budapest, Hungary, 1097
India
Novartis Investigative Site
Mumbai, Maharashtra, India, 400 036
Italy
Novartis Investigative Site
Parma, PR, Italy, 43100
Novartis Investigative Site
Pavia, PV, Italy, 27100
Novartis Investigative Site
Roma, RM, Italy, 00161
Novartis Investigative Site
Torino, TO, Italy, 10126
Korea, Republic of
Novartis Investigative Site
Busan, Korea, Republic of, 49241
Novartis Investigative Site
Pusan, Korea, Republic of, 614-735
Poland
Novartis Investigative Site
Bialystok, Poland, 15-540
Novartis Investigative Site
Warszawa, Poland, 01-201
Puerto Rico
Novartis Investigative Site
San Juan, Puerto Rico, 00909
Romania
Novartis Investigative Site
Bucharest, District 1, Romania, 050524
Novartis Investigative Site
Bucharest, District 3, Romania, 030317
Novartis Investigative Site
Bucharest, Romania, 020125
Novartis Investigative Site
Bucharest, Romania, 021105
Novartis Investigative Site
Iasi, Romania, 700506
Spain
Novartis Investigative Site
Barcelona, Catalunya, Spain, 08035
Taiwan
Novartis Investigative Site
Kaohsiung, Taiwan, 80756
Novartis Investigative Site
Kaohsiung, Taiwan, 83301
Novartis Investigative Site
Lin-Kou, Taiwan, 33305
Novartis Investigative Site
Taichung, Taiwan, 40447
Novartis Investigative Site
Yun-Lin, Taiwan, 640
Thailand
Novartis Investigative Site
Songkla, Thailand, 90110
Vietnam
Novartis Investigative Site
Ho Chi Minh, Vietnam
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02465203    
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 A
Hepatitis C
Hepatitis C, Chronic
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
Hepatitis, Chronic