Clinical trial NCT01168856: 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
Official 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)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hepatitis C, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-07-23
Enrollment: 734
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Chronic hepatitis C patients having received direct acting antiviral treatment in donor protocol

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.


Eligibility criteria: 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

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

Primary outcomes:
measure: Percentage of Participants With the Detectable HCV Ribonucleic Acid (RNA) Results in Resistance Monitoring Arm at Month 3
timeFrame: Month 3
measure: Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 6
timeFrame: Month 6
measure: Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 9
timeFrame: Month 9
measure: Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 12
timeFrame: Month 12
measure: Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 18
timeFrame: Month 18
measure: HCV RNA Levels in Resistance Monitoring Arm at Month 3
timeFrame: Month 3
measure: HCV RNA Levels in Resistance Monitoring Arm at Month 6
timeFrame: Month 6
measure: HCV RNA Levels in Resistance Monitoring Arm at Month 9
timeFrame: Month 9
measure: HCV RNA Levels in Resistance Monitoring Arm at Month 12
timeFrame: Month 12
measure: HCV RNA Levels in Resistance Monitoring Arm at Month 18
timeFrame: Month 18
measure: Mean Systolic Blood Pressure in Resistance Monitoring Arm at Month 3
timeFrame: Month 3
measure: Systolic Blood Pressure in Resistance Monitoring Arm at Month 6
timeFrame: Month 6
measure: Systolic Blood Pressure in Resistance Monitoring Arm at Month 9
timeFrame: Month 9
measure: Mean Systolic Blood Pressure in Resistance Monitoring Arm at Month 12
timeFrame: Month 12
measure: Mean Systolic Blood Pressure in Resistance Monitoring Arm at Month 18
timeFrame: Month 18
measure: Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 3
timeFrame: Month 3
measure: Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 6
timeFrame: Month 6
measure: Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 9
timeFrame: Month 9
measure: Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 12
timeFrame: Month 12
measure: Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 18
timeFrame: Month 18
measure: Mean Pulse Rate in Resistance Monitoring Arm at Month 3
timeFrame: Month 3
measure: Mean Pulse Rate in Resistance Monitoring Arm at Month 6
timeFrame: Month 6
measure: Mean Pulse Rate in Resistance Monitoring Arm at Month 9
timeFrame: Month 9
measure: Mean Pulse Rate in Resistance Monitoring Arm at Month 12
timeFrame: Month 12
measure: Mean Pulse Rate in Resistance Monitoring Arm at Month 18
timeFrame: Month 18
measure: Percentage of Participants Who Received Anti-HCV Medications in Resistance Monitoring Arm
timeFrame: Up to 18 months
measure: Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 6
timeFrame: Month 6
measure: Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 12
timeFrame: Month 12
measure: Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 24
timeFrame: Month 24
measure: Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 36
timeFrame: Month 36
measure: Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 6
timeFrame: Month 6
measure: Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 12
timeFrame: Month 12
measure: Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 24
timeFrame: Month 24
measure: Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 36
timeFrame: Month 36
measure: Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 6
timeFrame: Month 6
measure: Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 12
timeFrame: Month 12
measure: Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 24
timeFrame: Month 24
measure: Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 36
timeFrame: Month 36
measure: Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 6
timeFrame: Month 6
measure: Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 12
timeFrame: Month 12
measure: Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 24
timeFrame: Month 24
measure: Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 36
timeFrame: Month 36
measure: Mean Pulse Rate in SVR Durability Monitoring Arm at Month 6
timeFrame: Month 6
measure: Mean Pulse Rate in SVR Durability Monitoring Arm at Month 12
timeFrame: Month 12
measure: Mean Pulse Rate in SVR Durability Monitoring Arm at Month 24
timeFrame: Month 24
measure: Mean Pulse Rate in SVR Durability Monitoring Arm at Month 36
timeFrame: Month 36
measure: Number of Participants With Danoprevir (DNV) Resistance Status-Population Sequencing
timeFrame: Month 3-18
measure: Number of Participants With DNV Resistance Status-Clonal Sequencing
timeFrame: Month 3-18
measure: Number of Participants With Boceprevir (BOC) or Telaprevir (TVR) Resistance Status-Population Sequencing
timeFrame: Month 3-18
measure: Number of Participants With BOC or TVR Resistance Status-Clonal Sequencing
timeFrame: Month 3-18
measure: Number of Participants With Setrobuvir (STV) Resistance Status-Population Sequencing
timeFrame: Month 3-18
measure: Number of Participants With STV Resistance Status-Clonal Sequencing
timeFrame: Month 3-18
measure: Number of Participants Who Had Received Mericitabine (MCB)-Based Regimen and Enrolled in NV22688
timeFrame: Month 18
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Sacramento
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Francisco
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Englewood
country: United States
state: Colorado
city: Bradenton
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Decatur
country: United States
state: Georgia
city: Marietta
country: United States
state: Georgia
city: Honolulu
country: United States
state: Hawaii
city: Chicago
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Kansas City
country: United States
state: Kansas
city: New Orleans
country: United States
state: Louisiana
city: Detroit
country: United States
state: Michigan
city: Kansas City
country: United States
state: Missouri
city: Lebanon
country: United States
state: New Hampshire
city: Hillsborough
country: United States
state: New Jersey
city: Newark
country: United States
state: New Jersey
city: Manhasset
country: United States
state: New York
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: Providence
country: United States
state: Rhode Island
city: Nashville
country: United States
state: Tennessee
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Newport News
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Vancouver
country: United States
state: Washington
city: Darlinghurst
country: Australia
state: New South Wales
city: Kingswood
country: Australia
state: New South Wales
city: Sydney
country: Australia
state: New South Wales
city: Westmead
country: Australia
state: New South Wales
city: Greenslopes
country: Australia
state: Queensland
city: Herston
country: Australia
state: Queensland
city: Woolloongabba
country: Australia
state: Queensland
city: Adelaide
country: Australia
state: South Australia
city: Melbourne
country: Australia
state: Victoria
city: Melbourne
country: Australia
state: Victoria
city: Wien
country: Austria
city: Salvador
country: Brazil
state: BA
city: Porto Alegre
country: Brazil
state: RS
city: Ribeirao Preto
country: Brazil
state: SP
city: Calgary
country: Canada
state: Alberta
city: Edmonton
country: Canada
state: Alberta
city: Edmonton
country: Canada
state: Alberta
city: Vancouver
country: Canada
state: British Columbia
city: Vancouver
country: Canada
state: British Columbia
city: Vancouver
country: Canada
state: British Columbia
city: Vancouver
country: Canada
state: British Columbia
city: Victoria
country: Canada
state: British Columbia
city: Winnipeg
country: Canada
state: Manitoba
city: London
country: Canada
state: Ontario
city: Ottawa
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Clichy
country: France
city: Creteil
country: France
city: Lille
country: France
city: Marseille
country: France
city: Montpellier
country: France
city: Montpellier
country: France
city: Nice
country: France
city: Paris
country: France
city: Paris
country: France
city: Pessac
country: France
city: Rennes
country: France
city: Toulouse
country: France
city: Vandoeuvre-les-nancy
country: France
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Frankfurt Am Main
country: Germany
city: Hamburg
country: Germany
city: Hannover
country: Germany
city: Muenchen
country: Germany
city: Napoli
country: Italy
state: Campania
city: Bologna
country: Italy
state: Emilia-Romagna
city: Milano
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Pavia
country: Italy
state: Lombardia
city: Torino
country: Italy
state: Piemonte
city: Bari
country: Italy
state: Puglia
city: Pisa
country: Italy
state: Toscana
city: Guadalajara
country: Mexico
city: Guadalajara
country: Mexico
city: Monterrey
country: Mexico
city: Christchurch
country: New Zealand
city: Dunedin
country: New Zealand
city: Grafton
country: New Zealand
city: Bydgoszcz
country: Poland
city: Chorzow
country: Poland
city: Lodz
country: Poland
city: Myslowice
country: Poland
city: Warszawa
country: Poland
city: Warszawa
country: Poland
city: Wrocław
country: Poland
city: Łodz
country: Poland
city: San Juan
country: Puerto Rico
city: Bratislava
country: Slovakia
city: Badalona
country: Spain
state: Barcelona
city: Santander
country: Spain
state: Cantabria
city: Palma de Mallorca
country: Spain
state: Islas Baleares
city: La Coruna
country: Spain
state: La Coruña
city: La Laguna
country: Spain
state: Tenerife
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Pontevedra
country: Spain
city: Sevilla
country: Spain
city: Valencia
country: Spain
city: Dorset
country: United Kingdom
city: Dundee
country: United Kingdom
city: London
country: United Kingdom
city: London
country: United Kingdom
city: London
country: United Kingdom
city: London
country: United Kingdom
city: Manchester
country: United Kingdom
city: Nottingham
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: