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
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| ClinicalTrials.gov Identifier: NCT01168856 |
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Recruitment Status :
Terminated
(This study was terminated due to the decrease in percentage of participants.)
First Posted : July 23, 2010
Results First Posted : March 11, 2016
Last Update Posted : March 11, 2016
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| Condition or disease |
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| Hepatitis C, Chronic |
| Study Type : | Observational |
| Actual Enrollment : | 734 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| 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 Start Date : | September 2010 |
| Actual Primary Completion Date : | April 2015 |
| Actual Study Completion Date : | April 2015 |
| Group/Cohort |
|---|
| Cohort |
- Percentage of Participants With the Detectable HCV Ribonucleic Acid (RNA) Results in Resistance Monitoring Arm at Month 3 [ Time Frame: Month 3 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]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 ]
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 ]
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 ]
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 ]
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 ]
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 ]
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 ]Population sequencing was used for determination of loss of resistance status. Results are reported as per donor protocol.
Biospecimen Retention: None Retained
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01168856
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| Study Director: | Clinical Trials | Hoffmann-La Roche |
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT01168856 |
| Other Study ID Numbers: |
NV22688 2009-016560-36 ( EudraCT Number ) |
| First Posted: | July 23, 2010 Key Record Dates |
| Results First Posted: | March 11, 2016 |
| Last Update Posted: | March 11, 2016 |
| Last Verified: | February 2016 |
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Hepatitis A Hepatitis C Hepatitis C, Chronic Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases |
Infections Enterovirus Infections Picornaviridae Infections RNA Virus Infections Blood-Borne Infections Communicable Diseases Flaviviridae Infections Hepatitis, Chronic |