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

This study has been terminated.
(This study was terminated due to the decrease in percentage of participants.)
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01168856
First received: July 15, 2010
Last updated: February 12, 2016
Last verified: February 2016

July 15, 2010
February 12, 2016
September 2010
April 2015   (final data collection date for primary outcome measure)
  • Percentage of Participants With the Detectable HCV Ribonucleic Acid (RNA) Results in Resistance Monitoring Arm at Month 3 [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
    Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 International Units per milliliter [IU/mL]).
  • Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 6 [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
  • Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 9 [ Time Frame: Month 9 ] [ Designated as safety issue: No ]
    Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
  • Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 12 [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
  • Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 18 [ Time Frame: Month 18 ] [ Designated as safety issue: No ]
    Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
  • HCV RNA Levels in Resistance Monitoring Arm at Month 3 [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
    Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
  • HCV RNA Levels in Resistance Monitoring Arm at Month 6 [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
  • HCV RNA Levels in Resistance Monitoring Arm at Month 9 [ Time Frame: Month 9 ] [ Designated as safety issue: No ]
    Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
  • HCV RNA Levels in Resistance Monitoring Arm at Month 12 [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
  • HCV RNA Levels in Resistance Monitoring Arm at Month 18 [ Time Frame: Month 18 ] [ Designated as safety issue: No ]
    Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
  • Mean Systolic Blood Pressure in Resistance Monitoring Arm at Month 3 [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
    Any abnormalities in systolic blood pressure (units: millimeters of Mercury [Hg] [mmHg]) were reported at the discretion of principal investigator.
  • Systolic Blood Pressure in Resistance Monitoring Arm at Month 6 [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.
  • Systolic Blood Pressure in Resistance Monitoring Arm at Month 9 [ Time Frame: Month 9 ] [ Designated as safety issue: No ]
    Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.
  • Mean Systolic Blood Pressure in Resistance Monitoring Arm at Month 12 [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.
  • Mean Systolic Blood Pressure in Resistance Monitoring Arm at Month 18 [ Time Frame: Month 18 ] [ Designated as safety issue: No ]
    Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.
  • Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 3 [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
    Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.
  • Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 6 [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.
  • Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 9 [ Time Frame: Month 9 ] [ Designated as safety issue: No ]
    Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.
  • Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 12 [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.
  • Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 18 [ Time Frame: Month 18 ] [ Designated as safety issue: No ]
    Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.
  • Mean Pulse Rate in Resistance Monitoring Arm at Month 3 [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
    Any abnormalities in pulse rate were reported at the discretion of principal investigator.
  • Mean Pulse Rate in Resistance Monitoring Arm at Month 6 [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    Any abnormalities in pulse rate were reported at the discretion of principal investigator.
  • Mean Pulse Rate in Resistance Monitoring Arm at Month 9 [ Time Frame: Month 9 ] [ Designated as safety issue: No ]
    Any abnormalities in pulse rate were reported at the discretion of principal investigator.
  • Mean Pulse Rate in Resistance Monitoring Arm at Month 12 [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Any abnormalities in pulse rate were reported at the discretion of principal investigator.
  • Mean Pulse Rate in Resistance Monitoring Arm at Month 18 [ Time Frame: Month 18 ] [ Designated as safety issue: No ]
    Any abnormalities in pulse rate were reported at the discretion of principal investigator.
  • Percentage of Participants Who Received Anti-HCV Medications in Resistance Monitoring Arm [ Time Frame: Up to 18 months ] [ Designated as safety issue: No ]
    Percentage of participants who received any anti-HCV medication during the monitoring period was reported.
  • Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 6 [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
  • Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 12 [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
  • Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 24 [ Time Frame: Month 24 ] [ Designated as safety issue: No ]
    Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
  • Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 36 [ Time Frame: Month 36 ] [ Designated as safety issue: No ]
    Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
  • Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 6 [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
  • Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 12 [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
  • Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 24 [ Time Frame: Month 24 ] [ Designated as safety issue: No ]
    Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
  • Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 36 [ Time Frame: Month 36 ] [ Designated as safety issue: No ]
    Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).
  • Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 6 [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.
  • Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 12 [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.
  • Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 24 [ Time Frame: Month 24 ] [ Designated as safety issue: No ]
    Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.
  • Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 36 [ Time Frame: Month 36 ] [ Designated as safety issue: No ]
    Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.
  • Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 6 [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.
  • Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 12 [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.
  • Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 24 [ Time Frame: Month 24 ] [ Designated as safety issue: No ]
    Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.
  • Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 36 [ Time Frame: Month 36 ] [ Designated as safety issue: No ]
    Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.
  • Mean Pulse Rate in SVR Durability Monitoring Arm at Month 6 [ Time Frame: Month 6 ] [ Designated as safety issue: No ]
    Any abnormalities in pulse rate were reported at the discretion of principal investigator.
  • Mean Pulse Rate in SVR Durability Monitoring Arm at Month 12 [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
    Any abnormalities in pulse rate were reported at the discretion of principal investigator.
  • Mean Pulse Rate in SVR Durability Monitoring Arm at Month 24 [ Time Frame: Month 24 ] [ Designated as safety issue: No ]
    Any abnormalities in pulse rate were reported at the discretion of principal investigator.
  • Mean Pulse Rate in SVR Durability Monitoring Arm at Month 36 [ Time Frame: Month 36 ] [ Designated as safety issue: No ]
    Any abnormalities in pulse rate were reported at the discretion of principal investigator.
  • Number of Participants With Danoprevir (DNV) Resistance Status-Population Sequencing [ Time Frame: Month 3-18 ] [ Designated as safety issue: No ]

    Population sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of DNV resistance or without loss of DNV resistance.

    Results are reported as per donor protocol. Category 1: Number of participants with loss of resistance in NV22688. A total of 99 participants with resistance at the end of donor study by population sequencing were included in this analysis.

    Category 2: Number of participants with no loss of resistance in NV22688. A total of 33 participants with resistance at the end of donor study by population sequencing were included in this analysis.

    Category 3: Number of participants with loss of resistance in donor study. A total of 30 participants with no DNV resistance at the end of donor study by population sequencing enrolled in NV22688 were included in this analysis.

  • Number of Participants With DNV Resistance Status-Clonal Sequencing [ Time Frame: Month 3-18 ] [ Designated as safety issue: No ]

    Clonal sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of DNV resistance or without loss of DNV resistance.

    Category 1-Number of participants with loss of resistance in NV22688. A total of 64 participants with loss of resistance in NV22688 were included in this analysis.

    Category 2-Number of participants with no loss of resistance in NV22688. A total of 35 participants with no loss of resistance in NV22688 were included in this analysis.

    Category 3-Number of participants with loss of resistance in donor study. A total of 26 participants who had no DNV resistance at the end of donor study were analyzed by clonal sequencing in NV22688. Three participants from donor studies WV21913, NP28266 and NP27946, respectively were not analyzed by clonal sequencing in NV22688 as loss of resistance mutations was demonstrated by clonal sequencing in donor study.

  • Number of Participants With Boceprevir (BOC) or Telaprevir (TVR) Resistance Status-Population Sequencing [ Time Frame: Month 3-18 ] [ Designated as safety issue: No ]

    Population sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of BOC or TVR resistance or without loss of BOC or TVR resistance.

    Category 1-Number of participants with loss of resistance in NV22688. A total of 6 participants with resistance at the end of donor study by population sequencing were included in this analysis.

    Category 2-Number of participants with no loss resistance in NV22688. One participant with resistance at the end of donor study by population sequencing was included in this analysis.

    Category 3-Number of participants with loss of resistance in donor study. A total of 2 participants with no BOC or TVR resistance at the end of donor study by population sequencing enrolled in NV22688 were included in this analysis.

  • Number of Participants With BOC or TVR Resistance Status-Clonal Sequencing [ Time Frame: Month 3-18 ] [ Designated as safety issue: No ]

    Clonal sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of BOC or TVR resistance or without loss of BOC or TVR resistance.

    Category 1-Number of participants with loss of resistance in NV22688. A total of 3 participants with loss of resistance in NV22688 were included in this analysis.

    Category 2-Number of participants with no loss of resistance in NV22688. A total of 3 participants with no loss of resistance in NV22688 were included in this analysis.

    Category 3-Number of participants with loss of resistance in donor study. A total of 2 participants who had no resistance at the end of donor study were analyzed by clonal sequencing in NV22688.

  • Number of Participants With Setrobuvir (STV) Resistance Status-Population Sequencing [ Time Frame: Month 3-18 ] [ Designated as safety issue: No ]

    Population sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of STV resistance or without loss of STV resistance.

    Category 1-Number of participants with loss of resistance in NV22688. A total of 5 participants with resistance at the end of donor study by population sequencing were included in this analysis.

    Category 2-Number of participants with no loss resistance in NV22688. A total of 3 participants with resistance at the end of donor study by population sequencing were included in this analysis.

    Category 3-Number of participants with loss of resistance in donor study. A total of 3 participants with no STV resistance at the end of donor study by population sequencing enrolled in NV22688 were included in this analysis.

  • Number of Participants With STV Resistance Status-Clonal Sequencing [ Time Frame: Month 3-18 ] [ Designated as safety issue: No ]

    Clonal sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of STV resistance or without loss of STV resistance.

    Category 1-Number of participants with loss of resistance in NV22688. One participant with loss of resistance in NV22688 was included in this analysis.

    Category 2-Number of participants with no loss of resistance in NV22688. A total of 4 participants with no loss of resistance in NV22688 were included in this analysis.

    Category 3-Number of participants with loss of resistance in donor study. One participant with loss of resistance, analyzed by clonal sequencing in NV22688.

    Category 4-Number of participants with loss of resistance in donor study. Two participants with no loss of resistance, analyzed by clonal sequencing in NV22688.

  • Number of Participants Who Had Received Mericitabine (MCB)-Based Regimen and Enrolled in NV22688 [ Time Frame: Month 18 ] [ Designated as safety issue: No ]
    Population sequencing was used for determination of loss of resistance status. Results are reported as per donor protocol.
  • Persistance of DAA-associated resistant mutations following discontinuation of DAA therapy [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Durability of sustained virological response (SVR-24), defined as undetectable HCV RNA measured by Roche COBAS TaqMan HCV Test [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Collecting of serum specimens from patients with partial viral response or viral load rebound of viral response while on RO5024048 treatment, to monitor for resistance mutations in viral RNA [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01168856 on ClinicalTrials.gov Archive Site
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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
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)
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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   None Retained
Description:
Serum specimens collected from patients with partial viral response or viral load rebound of viral response to monitor for resistance mutations in viral RNA
Probability Sample
Chronic hepatitis C patients having received direct acting antiviral treatment in donor protocol
Hepatitis C, Chronic
Not Provided
Cohort
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
734
April 2015
April 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Austria,   Brazil,   Canada,   France,   Germany,   Italy,   Mexico,   New Zealand,   Poland,   Puerto Rico,   Slovakia,   Spain,   United Kingdom
 
NCT01168856
NV22688, 2009-016560-36
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Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP