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

NCT ID: NCT02465203

Last Updated: 2018-01-12

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-06

Study Completion Date

2014-01-23

Brief Summary

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

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Detailed Description

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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.

Conditions

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Hepatitis C, Chronic

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Follow up from feeder studies

Follow up arm

Group Type OTHER

Previous treatment in DEB025 study

Intervention Type DRUG

Follow-up after DEB025 active study

Interventions

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Previous treatment in DEB025 study

Follow-up after DEB025 active study

Intervention Type DRUG

Other Intervention Names

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Data was not collected

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

San Diego, California, United States

Site Status

Novartis Investigative Site

Ventura, California, United States

Site Status

Novartis Investigative Site

Honolulu, Hawaii, United States

Site Status

Novartis Investigative Site

Springfield, Illinois, United States

Site Status

Novartis Investigative Site

Arlington, Texas, United States

Site Status

Novartis Investigative Site

Houston, Texas, United States

Site Status

Novartis Investigative Site

San Antonio, Texas, United States

Site Status

Novartis Investigative Site

Westmead, New South Wales, Australia

Site Status

Novartis Investigative Site

Leuven, , Belgium

Site Status

Novartis Investigative Site

Torono, Ontario, Canada

Site Status

Novartis Investigative Site

Cologne, North Rhine-Westphalia, Germany

Site Status

Novartis Investigative Site

Berlin, , Germany

Site Status

Novartis Investigative Site

Freiburg im Breisgau, , Germany

Site Status

Novartis Investigative Site

Hamburg, , Germany

Site Status

Novartis Investigative Site

Hanover, , Germany

Site Status

Novartis Investigative Site

Kiel, , Germany

Site Status

Novartis Investigative Site

Budapest, , Hungary

Site Status

Novartis Investigative Site

Mumbai, Maharashtra, India

Site Status

Novartis Investigative Site

Parma, PR, Italy

Site Status

Novartis Investigative Site

Pavia, PV, Italy

Site Status

Novartis Investigative Site

Roma, RM, Italy

Site Status

Novartis Investigative Site

Torino, TO, Italy

Site Status

Novartis Investigative Site

Bialystok, , Poland

Site Status

Novartis Investigative Site

Warsaw, , Poland

Site Status

Novartis Investigative Site

San Juan, , Puerto Rico

Site Status

Novartis Investigative Site

Bucharest, District 1, Romania

Site Status

Novartis Investigative Site

Bucharest, District 3, Romania

Site Status

Novartis Investigative Site

Bucharest, , Romania

Site Status

Novartis Investigative Site

Bucharest, , Romania

Site Status

Novartis Investigative Site

Iași, , Romania

Site Status

Novartis Investigative Site

Busan, , South Korea

Site Status

Novartis Investigative Site

Pusan, , South Korea

Site Status

Novartis Investigative Site

Barcelona, Catalonia, Spain

Site Status

Novartis Investigative Site

Douliu, , Taiwan

Site Status

Novartis Investigative Site

Kaohsiung City, , Taiwan

Site Status

Novartis Investigative Site

Kaohsiung City, , Taiwan

Site Status

Novartis Investigative Site

Linkou District, , Taiwan

Site Status

Novartis Investigative Site

Taichung, , Taiwan

Site Status

Novartis Investigative Site

Songkhla, , Thailand

Site Status

Novartis Investigative Site

Ho Chi Minh City, , Vietnam

Site Status

Countries

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United States Australia Belgium Canada Germany Hungary India Italy Poland Puerto Rico Romania South Korea Spain Taiwan Thailand Vietnam

Other Identifiers

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2011-006132-24

Identifier Type: -

Identifier Source: secondary_id

CDEB025A2313

Identifier Type: -

Identifier Source: org_study_id

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