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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01168856




Registration number
NCT01168856
Ethics application status
Date submitted
15/07/2010
Date registered
23/07/2010
Date last updated
11/03/2016

Titles & IDs
Public title
An Observational Study on Long-Term Persistence of Resistant Mutations And Durability of Sustained Virological Response in Patients With Chronic Hepatitis C Treated With Direct Acting Antiviral (DAA)- Containing Regimens
Scientific title
A Long-term Monitoring Study to Evaluate the Persistence of Direct Antiviral (DAA) Treatment Resistant Mutations or the Durability of Sustained Virological Response (SVR) in Patients Treated With DAA Containing Regimens for Chronic Hepatitis C Infections (CHC)
Secondary ID [1] 0 0
2009-016560-36
Secondary ID [2] 0 0
NV22688
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
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Cohort -

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With the Detectable HCV Ribonucleic Acid (RNA) Results in Resistance Monitoring Arm at Month 3
Timepoint [1] 0 0
Month 3
Primary outcome [2] 0 0
Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 6
Timepoint [2] 0 0
Month 6
Primary outcome [3] 0 0
Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 9
Timepoint [3] 0 0
Month 9
Primary outcome [4] 0 0
Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 12
Timepoint [4] 0 0
Month 12
Primary outcome [5] 0 0
Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 18
Timepoint [5] 0 0
Month 18
Primary outcome [6] 0 0
HCV RNA Levels in Resistance Monitoring Arm at Month 3
Timepoint [6] 0 0
Month 3
Primary outcome [7] 0 0
HCV RNA Levels in Resistance Monitoring Arm at Month 6
Timepoint [7] 0 0
Month 6
Primary outcome [8] 0 0
HCV RNA Levels in Resistance Monitoring Arm at Month 9
Timepoint [8] 0 0
Month 9
Primary outcome [9] 0 0
HCV RNA Levels in Resistance Monitoring Arm at Month 12
Timepoint [9] 0 0
Month 12
Primary outcome [10] 0 0
HCV RNA Levels in Resistance Monitoring Arm at Month 18
Timepoint [10] 0 0
Month 18
Primary outcome [11] 0 0
Mean Systolic Blood Pressure in Resistance Monitoring Arm at Month 3
Timepoint [11] 0 0
Month 3
Primary outcome [12] 0 0
Systolic Blood Pressure in Resistance Monitoring Arm at Month 6
Timepoint [12] 0 0
Month 6
Primary outcome [13] 0 0
Systolic Blood Pressure in Resistance Monitoring Arm at Month 9
Timepoint [13] 0 0
Month 9
Primary outcome [14] 0 0
Mean Systolic Blood Pressure in Resistance Monitoring Arm at Month 12
Timepoint [14] 0 0
Month 12
Primary outcome [15] 0 0
Mean Systolic Blood Pressure in Resistance Monitoring Arm at Month 18
Timepoint [15] 0 0
Month 18
Primary outcome [16] 0 0
Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 3
Timepoint [16] 0 0
Month 3
Primary outcome [17] 0 0
Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 6
Timepoint [17] 0 0
Month 6
Primary outcome [18] 0 0
Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 9
Timepoint [18] 0 0
Month 9
Primary outcome [19] 0 0
Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 12
Timepoint [19] 0 0
Month 12
Primary outcome [20] 0 0
Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 18
Timepoint [20] 0 0
Month 18
Primary outcome [21] 0 0
Mean Pulse Rate in Resistance Monitoring Arm at Month 3
Timepoint [21] 0 0
Month 3
Primary outcome [22] 0 0
Mean Pulse Rate in Resistance Monitoring Arm at Month 6
Timepoint [22] 0 0
Month 6
Primary outcome [23] 0 0
Mean Pulse Rate in Resistance Monitoring Arm at Month 9
Timepoint [23] 0 0
Month 9
Primary outcome [24] 0 0
Mean Pulse Rate in Resistance Monitoring Arm at Month 12
Timepoint [24] 0 0
Month 12
Primary outcome [25] 0 0
Mean Pulse Rate in Resistance Monitoring Arm at Month 18
Timepoint [25] 0 0
Month 18
Primary outcome [26] 0 0
Percentage of Participants Who Received Anti-HCV Medications in Resistance Monitoring Arm
Timepoint [26] 0 0
Up to 18 months
Primary outcome [27] 0 0
Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 6
Timepoint [27] 0 0
Month 6
Primary outcome [28] 0 0
Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 12
Timepoint [28] 0 0
Month 12
Primary outcome [29] 0 0
Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 24
Timepoint [29] 0 0
Month 24
Primary outcome [30] 0 0
Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 36
Timepoint [30] 0 0
Month 36
Primary outcome [31] 0 0
Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 6
Timepoint [31] 0 0
Month 6
Primary outcome [32] 0 0
Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 12
Timepoint [32] 0 0
Month 12
Primary outcome [33] 0 0
Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 24
Timepoint [33] 0 0
Month 24
Primary outcome [34] 0 0
Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 36
Timepoint [34] 0 0
Month 36
Primary outcome [35] 0 0
Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 6
Timepoint [35] 0 0
Month 6
Primary outcome [36] 0 0
Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 12
Timepoint [36] 0 0
Month 12
Primary outcome [37] 0 0
Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 24
Timepoint [37] 0 0
Month 24
Primary outcome [38] 0 0
Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 36
Timepoint [38] 0 0
Month 36
Primary outcome [39] 0 0
Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 6
Timepoint [39] 0 0
Month 6
Primary outcome [40] 0 0
Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 12
Timepoint [40] 0 0
Month 12
Primary outcome [41] 0 0
Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 24
Timepoint [41] 0 0
Month 24
Primary outcome [42] 0 0
Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 36
Timepoint [42] 0 0
Month 36
Primary outcome [43] 0 0
Mean Pulse Rate in SVR Durability Monitoring Arm at Month 6
Timepoint [43] 0 0
Month 6
Primary outcome [44] 0 0
Mean Pulse Rate in SVR Durability Monitoring Arm at Month 12
Timepoint [44] 0 0
Month 12
Primary outcome [45] 0 0
Mean Pulse Rate in SVR Durability Monitoring Arm at Month 24
Timepoint [45] 0 0
Month 24
Primary outcome [46] 0 0
Mean Pulse Rate in SVR Durability Monitoring Arm at Month 36
Timepoint [46] 0 0
Month 36
Primary outcome [47] 0 0
Number of Participants With Danoprevir (DNV) Resistance Status-Population Sequencing
Timepoint [47] 0 0
Month 3-18
Primary outcome [48] 0 0
Number of Participants With DNV Resistance Status-Clonal Sequencing
Timepoint [48] 0 0
Month 3-18
Primary outcome [49] 0 0
Number of Participants With Boceprevir (BOC) or Telaprevir (TVR) Resistance Status-Population Sequencing
Timepoint [49] 0 0
Month 3-18
Primary outcome [50] 0 0
Number of Participants With BOC or TVR Resistance Status-Clonal Sequencing
Timepoint [50] 0 0
Month 3-18
Primary outcome [51] 0 0
Number of Participants With Setrobuvir (STV) Resistance Status-Population Sequencing
Timepoint [51] 0 0
Month 3-18
Primary outcome [52] 0 0
Number of Participants With STV Resistance Status-Clonal Sequencing
Timepoint [52] 0 0
Month 3-18
Primary outcome [53] 0 0
Number of Participants Who Had Received Mericitabine (MCB)-Based Regimen and Enrolled in NV22688
Timepoint [53] 0 0
Month 18

Eligibility
Key inclusion criteria
* adult patients, >/=18 years of age
* chronic hepatitis C
* participation in Roche DAA treatment protocol for CHC infection
* DAA-associated resistant mutations persisting through to last evaluation in donor protocol , or partial viral response or viral load rebound while on RO5024048 treatment, or sustained virological response >/= 20 weeks after last dose of study medication in donor study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* For patients participating in DAA resistance monitoring: Initiation of treatment after participation in the donor protocol for which there is evidence of cross-resistance to donor protocol DAA
* For patients participating in DAA SVR durability: Treatment with any anti-HVC therapy since establishing SVR in the donor study

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2015
Sample size
Target
Accrual to date
Final
734
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
- Darlinghurst
Recruitment hospital [2] 0 0
- Kingswood
Recruitment hospital [3] 0 0
- Sydney
Recruitment hospital [4] 0 0
- Westmead
Recruitment hospital [5] 0 0
- Greenslopes
Recruitment hospital [6] 0 0
- Herston
Recruitment hospital [7] 0 0
- Woolloongabba
Recruitment hospital [8] 0 0
- Adelaide
Recruitment hospital [9] 0 0
- Melbourne
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2747 - Kingswood
Recruitment postcode(s) [3] 0 0
2050 - Sydney
Recruitment postcode(s) [4] 0 0
2145 - Westmead
Recruitment postcode(s) [5] 0 0
4120 - Greenslopes
Recruitment postcode(s) [6] 0 0
4029 - Herston
Recruitment postcode(s) [7] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [8] 0 0
5000 - Adelaide
Recruitment postcode(s) [9] 0 0
3181 - Melbourne
Recruitment postcode(s) [10] 0 0
3186 - Melbourne
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
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Hawaii
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Kansas
Country [9] 0 0
United States of America
State/province [9] 0 0
Louisiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Michigan
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
New Hampshire
Country [13] 0 0
United States of America
State/province [13] 0 0
New Jersey
Country [14] 0 0
United States of America
State/province [14] 0 0
New York
Country [15] 0 0
United States of America
State/province [15] 0 0
Rhode Island
Country [16] 0 0
United States of America
State/province [16] 0 0
Tennessee
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
United States of America
State/province [18] 0 0
Virginia
Country [19] 0 0
United States of America
State/province [19] 0 0
Washington
Country [20] 0 0
Austria
State/province [20] 0 0
Wien
Country [21] 0 0
Brazil
State/province [21] 0 0
BA
Country [22] 0 0
Brazil
State/province [22] 0 0
RS
Country [23] 0 0
Brazil
State/province [23] 0 0
SP
Country [24] 0 0
Canada
State/province [24] 0 0
Alberta
Country [25] 0 0
Canada
State/province [25] 0 0
British Columbia
Country [26] 0 0
Canada
State/province [26] 0 0
Manitoba
Country [27] 0 0
Canada
State/province [27] 0 0
Ontario
Country [28] 0 0
Canada
State/province [28] 0 0
Quebec
Country [29] 0 0
France
State/province [29] 0 0
Clichy
Country [30] 0 0
France
State/province [30] 0 0
Creteil
Country [31] 0 0
France
State/province [31] 0 0
Lille
Country [32] 0 0
France
State/province [32] 0 0
Marseille
Country [33] 0 0
France
State/province [33] 0 0
Montpellier
Country [34] 0 0
France
State/province [34] 0 0
Nice
Country [35] 0 0
France
State/province [35] 0 0
Paris
Country [36] 0 0
France
State/province [36] 0 0
Pessac
Country [37] 0 0
France
State/province [37] 0 0
Rennes
Country [38] 0 0
France
State/province [38] 0 0
Toulouse
Country [39] 0 0
France
State/province [39] 0 0
Vandoeuvre-les-nancy
Country [40] 0 0
Germany
State/province [40] 0 0
Berlin
Country [41] 0 0
Germany
State/province [41] 0 0
Frankfurt Am Main
Country [42] 0 0
Germany
State/province [42] 0 0
Hamburg
Country [43] 0 0
Germany
State/province [43] 0 0
Hannover
Country [44] 0 0
Germany
State/province [44] 0 0
Muenchen
Country [45] 0 0
Italy
State/province [45] 0 0
Campania
Country [46] 0 0
Italy
State/province [46] 0 0
Emilia-Romagna
Country [47] 0 0
Italy
State/province [47] 0 0
Lombardia
Country [48] 0 0
Italy
State/province [48] 0 0
Piemonte
Country [49] 0 0
Italy
State/province [49] 0 0
Puglia
Country [50] 0 0
Italy
State/province [50] 0 0
Toscana
Country [51] 0 0
Mexico
State/province [51] 0 0
Guadalajara
Country [52] 0 0
Mexico
State/province [52] 0 0
Monterrey
Country [53] 0 0
New Zealand
State/province [53] 0 0
Christchurch
Country [54] 0 0
New Zealand
State/province [54] 0 0
Dunedin
Country [55] 0 0
New Zealand
State/province [55] 0 0
Grafton
Country [56] 0 0
Poland
State/province [56] 0 0
Bydgoszcz
Country [57] 0 0
Poland
State/province [57] 0 0
Chorzow
Country [58] 0 0
Poland
State/province [58] 0 0
Lodz
Country [59] 0 0
Poland
State/province [59] 0 0
Myslowice
Country [60] 0 0
Poland
State/province [60] 0 0
Warszawa
Country [61] 0 0
Poland
State/province [61] 0 0
Wroclaw
Country [62] 0 0
Puerto Rico
State/province [62] 0 0
San Juan
Country [63] 0 0
Slovakia
State/province [63] 0 0
Bratislava
Country [64] 0 0
Spain
State/province [64] 0 0
Barcelona
Country [65] 0 0
Spain
State/province [65] 0 0
Cantabria
Country [66] 0 0
Spain
State/province [66] 0 0
Islas Baleares
Country [67] 0 0
Spain
State/province [67] 0 0
La Coruña
Country [68] 0 0
Spain
State/province [68] 0 0
Tenerife
Country [69] 0 0
Spain
State/province [69] 0 0
Madrid
Country [70] 0 0
Spain
State/province [70] 0 0
Pontevedra
Country [71] 0 0
Spain
State/province [71] 0 0
Sevilla
Country [72] 0 0
Spain
State/province [72] 0 0
Valencia
Country [73] 0 0
United Kingdom
State/province [73] 0 0
Dorset
Country [74] 0 0
United Kingdom
State/province [74] 0 0
Dundee
Country [75] 0 0
United Kingdom
State/province [75] 0 0
London
Country [76] 0 0
United Kingdom
State/province [76] 0 0
Manchester
Country [77] 0 0
United Kingdom
State/province [77] 0 0
Nottingham

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This observational long-term follow-up study will assess the persistence of direct acting antiviral (DAA) resistant mutations and the durability of sustained virological response in patients with chronic hepatitis C who have participated in a Roche DAA treatment protocol. Up to 5 scheduled monitoring visits for blood sampling during an observational period of up to 36 months.
Trial website
https://clinicaltrials.gov/study/NCT01168856
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
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/study/NCT01168856