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

Primary Purpose

Hepatitis C, Chronic

Status

Terminated

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Previous treatment in DEB025 study

About this trial

This is an interventional other trial for Hepatitis C, Chronic focused on measuring Hepatitis C, chronic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

Use of any investigational drugs within 5 half-lives of enrollment, or within 30 days of that medication, whichever is longer.
Previous use of any course of hepatitis C therapy since the end of the Novartis-sponsored hepatitis C study

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Follow up from feeder studies

Arm Description

Follow up arm

Outcomes

Primary Outcome Measures

HCV RNA Sequencing

Persistence of resistance associated variants

Secondary Outcome Measures

Safety Parameters as Measured by HCV RNA Sequencing

Phenotypic analysis of HCV isolates to determine the patients susceptibility/resistance to alisporivir in vitro

Safety Parameters as Measured by FibroScan/Fibrotest and Lab Parameters

Changes in liver function and disease over time

Safety Parameters as Measured by Liver UltraSound and Lab Parameters

Development of hepatocellular carcinoma (HCC)

Safety Parameters

Safety over time of previous alisporivir exposure

Full Information

NCT ID

NCT02465203

First Posted

March 17, 2015

Last Updated

December 13, 2017

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT02465203

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2017

Overall Recruitment Status

Terminated

Why Stopped

Study was prematurely terminated.

Study Start Date

September 6, 2012 (Actual)

Primary Completion Date

January 23, 2014 (Actual)

Study Completion Date

January 23, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis C, Chronic

Keywords

Hepatitis C, chronic

7. Study Design

Primary Purpose

Other

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

105 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Follow up from feeder studies

Arm Type

Other

Arm Description

Follow up arm

Intervention Type

Drug

Intervention Name(s)

Previous treatment in DEB025 study

Other Intervention Name(s)

Data was not collected

Intervention Description

Follow-up after DEB025 active study

Primary Outcome Measure Information:

Title

HCV RNA Sequencing

Description

Persistence of resistance associated variants

Time Frame

27 months

Secondary Outcome Measure Information:

Title

Safety Parameters as Measured by HCV RNA Sequencing

Description

Phenotypic analysis of HCV isolates to determine the patients susceptibility/resistance to alisporivir in vitro

Time Frame

27 months

Title

Safety Parameters as Measured by FibroScan/Fibrotest and Lab Parameters

Description

Changes in liver function and disease over time

Time Frame

27 months

Title

Safety Parameters as Measured by Liver UltraSound and Lab Parameters

Description

Development of hepatocellular carcinoma (HCC)

Time Frame

27 months

Title

Safety Parameters

Description

Safety over time of previous alisporivir exposure

Time Frame

27 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Males or females aged ≥18 Have previously completed a Novartis-sponsored hepatitis C study and received alisporivir or a direct antiviral agent (DAA) Have not achieved SVR24 Exclusion Criteria: Use of any investigational drugs within 5 half-lives of enrollment, or within 30 days of that medication, whichever is longer. Previous use of any course of hepatitis C therapy since the end of the Novartis-sponsored hepatitis C study

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Novartis Pharmaceuticals

Organizational Affiliation

Novartis Pharmaceuticals

Official's Role

Study Director

Facility Information:

Facility Name

Novartis Investigative Site

City

San Diego

State/Province

California

ZIP/Postal Code

92101

Country

United States

Facility Name

Novartis Investigative Site

City

Ventura

State/Province

California

ZIP/Postal Code

93003

Country

United States

Facility Name

Novartis Investigative Site

City

Honolulu

State/Province

Hawaii

ZIP/Postal Code

96814

Country

United States

Facility Name

Novartis Investigative Site

City

Springfield

State/Province

Illinois

ZIP/Postal Code

62703

Country

United States

Facility Name

Novartis Investigative Site

City

Arlington

State/Province

Texas

ZIP/Postal Code

76012

Country

United States

Facility Name

Novartis Investigative Site

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

Facility Name

Novartis Investigative Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78215

Country

United States

Facility Name

Novartis Investigative Site

City

Westmead

State/Province

New South Wales

ZIP/Postal Code

2145

Country

Australia

Facility Name

Novartis Investigative Site

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

Novartis Investigative Site

City

Torono

State/Province

Ontario

ZIP/Postal Code

M5G 2C4

Country

Canada

Facility Name

Novartis Investigative Site

City

Koeln

State/Province

Nordrhein-Westfalen

ZIP/Postal Code

50937

Country

Germany

Facility Name

Novartis Investigative Site

City

Berlin

ZIP/Postal Code

13353

Country

Germany

Facility Name

Novartis Investigative Site

City

Freiburg

ZIP/Postal Code

79106

Country

Germany

Facility Name

Novartis Investigative Site

City

Hamburg

ZIP/Postal Code

20099

Country

Germany

Facility Name

Novartis Investigative Site

City

Hannover

ZIP/Postal Code

30625

Country

Germany

Facility Name

Novartis Investigative Site

City

Kiel

ZIP/Postal Code

24146

Country

Germany

Facility Name

Novartis Investigative Site

City

Budapest

ZIP/Postal Code

1097

Country

Hungary

Facility Name

Novartis Investigative Site

City

Mumbai

State/Province

Maharashtra

ZIP/Postal Code

400 036

Country

India

Facility Name

Novartis Investigative Site

City

Parma

State/Province

ZIP/Postal Code

43100

Country

Italy

Facility Name

Novartis Investigative Site

City

Pavia

State/Province

ZIP/Postal Code

27100

Country

Italy

Facility Name

Novartis Investigative Site

City

Roma

State/Province

ZIP/Postal Code

00161

Country

Italy

Facility Name

Novartis Investigative Site

City

Torino

State/Province

ZIP/Postal Code

10126

Country

Italy

Facility Name

Novartis Investigative Site

City

Busan

ZIP/Postal Code

49241

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Pusan

ZIP/Postal Code

614-735

Country

Korea, Republic of

Facility Name

Novartis Investigative Site

City

Bialystok

ZIP/Postal Code

15-540

Country

Poland

Facility Name

Novartis Investigative Site

City

Warszawa

ZIP/Postal Code

01-201

Country

Poland

Facility Name

Novartis Investigative Site

City

San Juan

ZIP/Postal Code

00909

Country

Puerto Rico

Facility Name

Novartis Investigative Site

City

Bucharest

State/Province

District 1

ZIP/Postal Code

050524

Country

Romania

Facility Name

Novartis Investigative Site

City

Bucharest

State/Province

District 3

ZIP/Postal Code

030317

Country

Romania

Facility Name

Novartis Investigative Site

City

Bucharest

ZIP/Postal Code

020125

Country

Romania

Facility Name

Novartis Investigative Site

City

Bucharest

ZIP/Postal Code

021105

Country

Romania

Facility Name

Novartis Investigative Site

City

Iasi

ZIP/Postal Code

700506

Country

Romania

Facility Name

Novartis Investigative Site

City

Barcelona

State/Province

Catalunya

ZIP/Postal Code

08035

Country

Spain

Facility Name

Novartis Investigative Site

City

Kaohsiung

ZIP/Postal Code

80756

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Kaohsiung

ZIP/Postal Code

83301

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Lin-Kou

ZIP/Postal Code

33305

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Taichung

ZIP/Postal Code

40447

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Yun-Lin

ZIP/Postal Code

640

Country

Taiwan

Facility Name

Novartis Investigative Site

City

Songkla

ZIP/Postal Code

90110

Country

Thailand

Facility Name

Novartis Investigative Site

City

Ho Chi Minh

Country

Vietnam

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

terminated

Learn more about this trial

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

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

Hepatitis C, Chronic

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial