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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02753699




Registration number
NCT02753699
Ethics application status
Date submitted
16/03/2016
Date registered
28/04/2016
Date last updated
26/08/2016

Titles & IDs
Public title
Long Term Follow-up Study to Assess Durability of Sustained Virologic Response in Alisporivir-treated Hepatitis C Patients
Scientific title
A Multi-centre Long Term Follow-up Study to Assess the Durability of Sustained Virologic Response in Alisporivir-treated Chronic Hepatitis C Patients
Secondary ID [1] 0 0
2011-006131-38
Secondary ID [2] 0 0
CDEB025A2312
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Alisporivir

Experimental: From Study 2210 - All participants enrolled from CDEB025A2210 (n=164) who had been treated with alisporivir during the feeder study. There was no investigational treatment given to participants while enrolled in this follow-up study.

Experimental: From Study 2301 - All participants enrolled from CDEB025A2301 (n=397) who had been treated with alisporivir during the feeder study. There was no investigational treatment given to participants while enrolled in this follow-up study.

Experimental: From Study 2211 - All participants enrolled from CDEB025A2211 (n=162) who had been treated with alisporivir during the feeder study. There was no investigational treatment given to participants while enrolled in this follow-up study.


Treatment: Drugs: Alisporivir
Intervention of interest; follow-up after ALV-active study

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants Maintaining Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Load Below the Level of Quantification (LOQ) Through Week 48
Timepoint [1] 0 0
up to 120 Weeks
Secondary outcome [1] 0 0
Percentage of Participants With Normal Alanine-aminotransferase (ALT) Values at Week 48. - Note that the 24-week period between end of feeder study (SVR24) and first visit in this follow-up study is not counted in the 48 weeks, so this timepoint corresponds to 96 weeks (=24+24+48) after the last dose of alisporivir.
Timepoint [1] 0 0
at Week 48

Eligibility
Key inclusion criteria
1. Provides written informed consent before any assessment is performed

2. Is male or female aged =18

3. Has previously completed a Novartis-sponsored hepatitis C study and received
alisporivir

4. Has achieved SVR24

5. Is able to comply with the visit schedule
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

3. No additional exclusions are to be applied by the Investigator, in order to ensure
that the study population is representative of all eligible patients.

Study design
Purpose of the study
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Kingswood
Recruitment hospital [2] 0 0
Novartis Investigative Site - Kogarah
Recruitment hospital [3] 0 0
Novartis Investigative Site - Westmead
Recruitment hospital [4] 0 0
Novartis Investigative Site - Greenslopes
Recruitment hospital [5] 0 0
Novartis Investigative Site - Fitzroy
Recruitment postcode(s) [1] 0 0
2747 - Kingswood
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
4120 - Greenslopes
Recruitment postcode(s) [5] 0 0
3065 - Fitzroy
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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Florida
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Hawaii
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Illinois
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Indiana
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Texas
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United States of America
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Utah
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Argentina
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Buenos Aires
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Belgium
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Gent
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Canada
State/province [10] 0 0
Alberta
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Canada
State/province [11] 0 0
British Columbia
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Canada
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Ontario
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France
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Clichy
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France
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Creteil
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France
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Lyon Cedex 04
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France
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Nice Cedex 3
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France
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Paris
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Germany
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Berlin
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Germany
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Frankfurt
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Germany
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Freiburg
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Germany
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Hamburg
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Germany
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Hannover
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Germany
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Kiel
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Germany
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Koeln
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Germany
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Leipzig
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Germany
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Mainz
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Hong Kong
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Hong Kong
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Hungary
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Bekescsaba
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Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Kaposvár
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Hungary
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Pecs
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Hungary
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Szekesfehervar
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India
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Andhra Pradesh
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India
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Maharashtra
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India
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Punjab
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India
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Delhi
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Italy
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BO
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Italy
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BS
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Italy
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MI
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Italy
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PA
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Italy
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PR
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Italy
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PV
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Italy
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RM
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Italy
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TO
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Italy
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Bologna
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Italy
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Napoli
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Gyeongsangnam-Do
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Korea, Republic of
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Korea
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Korea, Republic of
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Busan
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Korea, Republic of
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Incheon
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Korea, Republic of
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Pusan
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Distrito Federal
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Lódz
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Warszawa
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Zawiercie
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Bucharest
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Craiova
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Iasi
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Moscow
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Russian Federation
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St.- Petersburg
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Andalucia
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Spain
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Catalunya
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Spain
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Comunidad Valenciana
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Spain
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Madrid
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Chia-Yi
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Kaohsiung
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Taiwan
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Keelung City
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Taiwan
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Lin-Kou
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Taiwan
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Niaosong Township
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Taiwan
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Taichung
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Taiwan
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Taipei
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Taiwan
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Yun-Lin
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Thailand
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Bangkok
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Thailand
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Chiang Mai
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Thailand
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Khon Kaen
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Thailand
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Songkla
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Turkey
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Fatih / Istanbul
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Turkey
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Izmir
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United Kingdom
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Birmingham
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United Kingdom
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Glasgow - Scotland
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United Kingdom
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London
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United Kingdom
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Newcastle Upon Tyne
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United Kingdom
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Nottingham
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United Kingdom
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Plymouth
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Vietnam
State/province [90] 0 0
Hanoi
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Vietnam
State/province [91] 0 0
Ho Chi Minh

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Debiopharm International SA
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to follow-up with participants from feeder studies who achieved
sustained virologic response (SVR) over 24 hours posttreatment (SVR24), to assess durability
of SVR, and to assess the changes in liver disease, development of hepatocellular carcinoma
and post-treatment safety over time.

Participants enter this study from feeder studies CDEB025A2210 (NCT01183169), CDEB025A2301
(NCT01318694), and CDEB025A2211 (NCT01215643). They return to the site for up to 48 weeks
with a maximum of 3 visits. No treatment is involved.
Trial website
https://clinicaltrials.gov/show/NCT02753699
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications