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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02465203




Registration number
NCT02465203
Ethics application status
Date submitted
17/03/2015
Date registered
8/06/2015
Date last updated
12/01/2018

Titles & IDs
Public title
3-year Follow-up Study to Assess the Viral Activity in Hepatitis C Patients Who Failed Feeder DEB025/Alisporivir Study
Scientific 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
Secondary ID [1] 0 0
2011-006132-24
Secondary ID [2] 0 0
CDEB025A2313
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C, Chronic 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 - Previous treatment in DEB025 study

Other: Follow up from feeder studies - Follow up arm


Treatment: Drugs: Previous treatment in DEB025 study
Follow-up after DEB025 active study

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

Outcomes
Primary outcome [1] 0 0
HCV RNA Sequencing - Persistence of resistance associated variants
Timepoint [1] 0 0
27 months
Secondary outcome [1] 0 0
Safety Parameters as Measured by HCV RNA Sequencing - Phenotypic analysis of HCV isolates to determine the patients susceptibility/resistance to alisporivir in vitro
Timepoint [1] 0 0
27 months
Secondary outcome [2] 0 0
Safety Parameters as Measured by FibroScan/Fibrotest and Lab Parameters - Changes in liver function and disease over time
Timepoint [2] 0 0
27 months
Secondary outcome [3] 0 0
Safety Parameters as Measured by Liver UltraSound and Lab Parameters - Development of hepatocellular carcinoma (HCC)
Timepoint [3] 0 0
27 months
Secondary outcome [4] 0 0
Safety Parameters - Safety over time of previous alisporivir exposure
Timepoint [4] 0 0
27 months

Eligibility
Key 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
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. Previous use of any course of hepatitis C therapy since the end of the
Novartis-sponsored hepatitis C study

Study design
Purpose of the study
Other
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
Terminated
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
Recruitment hospital [1] 0 0
Novartis Investigative Site - Westmead
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Hawaii
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
Belgium
State/province [5] 0 0
Leuven
Country [6] 0 0
Canada
State/province [6] 0 0
Ontario
Country [7] 0 0
Germany
State/province [7] 0 0
Nordrhein-Westfalen
Country [8] 0 0
Germany
State/province [8] 0 0
Berlin
Country [9] 0 0
Germany
State/province [9] 0 0
Freiburg
Country [10] 0 0
Germany
State/province [10] 0 0
Hamburg
Country [11] 0 0
Germany
State/province [11] 0 0
Hannover
Country [12] 0 0
Germany
State/province [12] 0 0
Kiel
Country [13] 0 0
Hungary
State/province [13] 0 0
Budapest
Country [14] 0 0
India
State/province [14] 0 0
Maharashtra
Country [15] 0 0
Italy
State/province [15] 0 0
PR
Country [16] 0 0
Italy
State/province [16] 0 0
PV
Country [17] 0 0
Italy
State/province [17] 0 0
RM
Country [18] 0 0
Italy
State/province [18] 0 0
TO
Country [19] 0 0
Korea, Republic of
State/province [19] 0 0
Busan
Country [20] 0 0
Korea, Republic of
State/province [20] 0 0
Pusan
Country [21] 0 0
Poland
State/province [21] 0 0
Bialystok
Country [22] 0 0
Poland
State/province [22] 0 0
Warszawa
Country [23] 0 0
Puerto Rico
State/province [23] 0 0
San Juan
Country [24] 0 0
Romania
State/province [24] 0 0
District 1
Country [25] 0 0
Romania
State/province [25] 0 0
District 3
Country [26] 0 0
Romania
State/province [26] 0 0
Bucharest
Country [27] 0 0
Romania
State/province [27] 0 0
Iasi
Country [28] 0 0
Spain
State/province [28] 0 0
Catalunya
Country [29] 0 0
Taiwan
State/province [29] 0 0
Kaohsiung
Country [30] 0 0
Taiwan
State/province [30] 0 0
Lin-Kou
Country [31] 0 0
Taiwan
State/province [31] 0 0
Taichung
Country [32] 0 0
Taiwan
State/province [32] 0 0
Yun-Lin
Country [33] 0 0
Thailand
State/province [33] 0 0
Songkla
Country [34] 0 0
Vietnam
State/province [34] 0 0
Ho Chi Minh

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Follow-up for viral activity, changes in liver function and safety in patients with no SVR24
in feeder studies
Trial website
https://clinicaltrials.gov/show/NCT02465203
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
For IPD and results data, please see https://clinicaltrials.gov/show/NCT02465203