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

Hepatitis C, Chronic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02753699
• Other study ID #: CDEB025A2312
• Secondary ID: 2011-006131-38
• Status: Completed
• Phase: Phase 3
• First received: March 16, 2016
• Last updated: April 27, 2016
• Start date: December 2011
• Est. completion date: May 2015

Study information

• Verified date: April 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Follow-up for durability of sustained virologic response, changes in liver function and safety in patients with SVR24 in feeder studies

Description:

The purpose of this study is to follow patients from the feeder studies who have achieved SVR24 to assess durability of SVR24, and to assess the changes in liver disease, development of hepatocellular carcinoma and post-treatment safety over time.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 723
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Males or females aged =18

2. Have previously completed a Novartis-sponsored hepatitis C study and received alisporivir

3. Have 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. Use or planned use to start a new course of hepatitis C therapy

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic

Intervention

Drug:
• DEB025/Debio 025 (Alisporivir)
Follow-up after DEB025 active study

Locations

Country	Name	City	State
Argentina	Novartis Investigative Site	Buenos Aires
Argentina	Novartis Investigative Site	Buenos Aires
Australia	Novartis Investigative Site	Fitzroy	Victoria
Australia	Novartis Investigative Site	Greenslopes	Queensland
Australia	Novartis Investigative Site	Kingswood	New South Wales
Australia	Novartis Investigative Site	Kogarah	New South Wales
Australia	Novartis Investigative Site	Westmead	New South Wales
Belgium	Novartis Investigative Site	Gent
Canada	Novartis Investigative Site	Calgary	Alberta
Canada	Novartis Investigative Site	Torono	Ontario
Canada	Novartis Investigative Site	Vancouver	British Columbia
Canada	Novartis Investigative Site	Vancouver	British Columbia
France	Novartis Investigative Site	Clichy
France	Novartis Investigative Site	Creteil
France	Novartis Investigative Site	Lyon Cedex 04
France	Novartis Investigative Site	Nice Cedex 3
France	Novartis Investigative Site	Paris
Germany	Novartis Investigative Site	Berlin
Germany	Novartis Investigative Site	Frankfurt
Germany	Novartis Investigative Site	Freiburg
Germany	Novartis Investigative Site	Hamburg
Germany	Novartis Investigative Site	Hannover
Germany	Novartis Investigative Site	Kiel
Germany	Novartis Investigative Site	Koeln
Germany	Novartis Investigative Site	Leipzig
Germany	Novartis Investigative Site	Mainz
Hong Kong	Novartis Investigative Site	Hong Kong
Hungary	Novartis Investigative Site	Bekescsaba
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Budapest
Hungary	Novartis Investigative Site	Debrecen
Hungary	Novartis Investigative Site	Kaposvár
Hungary	Novartis Investigative Site	Pecs
Hungary	Novartis Investigative Site	Szekesfehervar
India	Novartis Investigative Site	Delhi
India	Novartis Investigative Site	Hyderabad	Andhra Pradesh
India	Novartis Investigative Site	Ludhiana	Punjab
India	Novartis Investigative Site	Mumbai	Maharashtra
Italy	Novartis Investigative Site	Bologna	BO
Italy	Novartis Investigative Site	Bologna
Italy	Novartis Investigative Site	Brescia	BS
Italy	Novartis Investigative Site	Milano	MI
Italy	Novartis Investigative Site	Milano	MI
Italy	Novartis Investigative Site	Milano	MI
Italy	Novartis Investigative Site	Napoli
Italy	Novartis Investigative Site	Palermo	PA
Italy	Novartis Investigative Site	Parma	PR
Italy	Novartis Investigative Site	Pavia	PV
Italy	Novartis Investigative Site	Roma	RM
Italy	Novartis Investigative Site	Roma	RM
Italy	Novartis Investigative Site	Rozzano	MI
Italy	Novartis Investigative Site	Torino	TO
Korea, Republic of	Novartis Investigative Site	Busan
Korea, Republic of	Novartis Investigative Site	Busan
Korea, Republic of	Novartis Investigative Site	Incheon
Korea, Republic of	Novartis Investigative Site	Pusan
Korea, Republic of	Novartis Investigative Site	Seongnam-si	Gyeonggi-do
Korea, Republic of	Novartis Investigative Site	Seoul	Korea
Korea, Republic of	Novartis Investigative Site	Yangsan-si	Gyeongsangnam-Do
Mexico	Novartis Investigative Site	México	Distrito Federal
Mexico	Novartis Investigative Site	Monterrey	Nuevo Leon
Poland	Novartis Investigative Site	Bialystok
Poland	Novartis Investigative Site	Bydgoszcz
Poland	Novartis Investigative Site	Lódz
Poland	Novartis Investigative Site	Warszawa
Poland	Novartis Investigative Site	Zawiercie
Romania	Novartis Investigative Site	Bucharest
Romania	Novartis Investigative Site	Bucharest
Romania	Novartis Investigative Site	Bucharest
Romania	Novartis Investigative Site	Bucharest
Romania	Novartis Investigative Site	Craiova
Romania	Novartis Investigative Site	Iasi
Romania	Novartis Investigative Site	Iasi
Russian Federation	Novartis Investigative Site	Moscow
Russian Federation	Novartis Investigative Site	St.- Petersburg
Spain	Novartis Investigative Site	Barcelona	Catalunya
Spain	Novartis Investigative Site	Barcelona	Catalunya
Spain	Novartis Investigative Site	Majadahonda	Madrid
Spain	Novartis Investigative Site	Sevilla	Andalucia
Spain	Novartis Investigative Site	Valencia	Comunidad Valenciana
Taiwan	Novartis Investigative Site	Chia-Yi
Taiwan	Novartis Investigative Site	Kaohsiung
Taiwan	Novartis Investigative Site	Keelung City
Taiwan	Novartis Investigative Site	Lin-Kou
Taiwan	Novartis Investigative Site	Niaosong Township
Taiwan	Novartis Investigative Site	Taichung
Taiwan	Novartis Investigative Site	Taipei
Taiwan	Novartis Investigative Site	Taipei
Taiwan	Novartis Investigative Site	Yun-Lin
Thailand	Novartis Investigative Site	Bangkok
Thailand	Novartis Investigative Site	Chiang Mai
Thailand	Novartis Investigative Site	Khon Kaen
Thailand	Novartis Investigative Site	Songkla
Turkey	Novartis Investigative Site	Fatih / Istanbul
Turkey	Novartis Investigative Site	Izmir
United Kingdom	Novartis Investigative Site	Birmingham
United Kingdom	Novartis Investigative Site	Glasgow - Scotland
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	London
United Kingdom	Novartis Investigative Site	Newcastle Upon Tyne
United Kingdom	Novartis Investigative Site	Nottingham
United Kingdom	Novartis Investigative Site	Plymouth
United States	Novartis Investigative Site	Arlington	Texas
United States	Novartis Investigative Site	Bradenton	Florida
United States	Novartis Investigative Site	Dallas	Texas
United States	Novartis Investigative Site	Honolulu	Hawaii
United States	Novartis Investigative Site	Houston	Texas
United States	Novartis Investigative Site	Indianapolis	Indiana
United States	Novartis Investigative Site	La Jolla	California
United States	Novartis Investigative Site	Salt Lake City	Utah
United States	Novartis Investigative Site	San Antonio	Texas
United States	Novartis Investigative Site	San Diego	California
United States	Novartis Investigative Site	Springfield	Illinois
United States	Novartis Investigative Site	Ventura	California
Vietnam	Novartis Investigative Site	Hanoi
Vietnam	Novartis Investigative Site	Hanoi
Vietnam	Novartis Investigative Site	Ho Chi Minh

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Vietnam,  Argentina,  Australia,  Belgium,  Canada,  France,  Germany,  Hong Kong,  Hungary,  India,  Italy,  Korea, Republic of,  Mexico,  Poland,  Romania,  Russian Federation,  Spain,  Taiwan,  Thailand,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HCV RNA viral load	The primary objective is to assess the durability of sustained virologic response after SVR24 has been achieved in patients treated with alisporivir in a Novartis-sponsored chronic Hepatitis C study	Through study completion (Day 1 to Week 48)	No
Secondary	Safety parameters as measured by FibroScan/Fibrotest and Lab Parameters (e.g. ALT, AST, GGT)	To assess the impact of successful alisporivir treatment on the change in liver disease over time	Through study completion (Day 1 to Week 48)	Yes
Secondary	Safety parameters as measured by Liver Ultrasound and Lab Parameters (e.g. alpha-fetoprotein)	To assess the development of hepatocellular carcinoma (HCC)	Through study completion (Day 1 to Week 48)	Yes
Secondary	Safety parameters as measured by AEs/SAEs and Lab Parameters (e.g. TGs, bilirubin, platelets)	To assess the safety over time of previous alisporivir exposure	Through study completion (Day 1 to Week 48)	Yes