Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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
Results First Received: December 30, 2015  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Hepatitis C, Chronic

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants from following studies were enrolled: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094].

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
This study was terminated early and participants discontinued due to study termination were included under reason "unspecified" in the participant flow.

Reporting Groups
  Description
Resistance Monitoring Arm Participants enrolled into this arm were those with Hepatitis C Virus (HCV) infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed direct acting antiviral (DAA)-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
Sustained Virological Response (SVR) Durability Monitoring Arm Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved Sustained Virological Response (SVR), defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test greater than or equal to (≥) 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.

Participant Flow:   Overall Study
    Resistance Monitoring Arm     Sustained Virological Response (SVR) Durability Monitoring Arm  
STARTED     176     558  
COMPLETED     158     215  
NOT COMPLETED     18     343  
Lost to Follow-up                 4                 34  
Withdrawal by Subject                 6                 8  
Physician Decision                 2                 1  
Confirmed Quantifiable HCV RNA                 0                 1  
Participant received anti-HCV treatment                 1                 0  
Death                 0                 2  
Unspecified                 1                 291  
Protocol Violation                 4                 6  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Eligible population included all enrolled participants excluding participants with protocol violations.

Reporting Groups
  Description
Resistance Monitoring Arm Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (Donor Protocols: NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had developed DAA-associated resistant mutation(s), which persisted through to the last evaluation of drug resistance in the donor protocol(s), or achieved only a partial viral response or experienced a viral breakthrough while on mericitabine treatment not associated with selection of S282T resistance mutations. Participants were monitored up to 18 months.
SVR Durability Monitoring Arm Participants enrolled into this arm were those with HCV infection who participated in one of the following studies (NV20536 [NCT00869661], NV21075 [NCT00963885], WV21913 [NCT01331850], NV22621 [NCT01057667], NP22660 [NCT01185860], NV22688 [NCT01168856], NV22776 [NCT01220947], PP25213 [NCT01278134], NV27779 [NCT01482390], NV27780 [NCT01482403], NP27946 [NCT01483742], YV28218 [NCT01749150], NP28266 [NCT01628094]) and had achieved SVR, defined within the donor protocol as measured by the Roche COBAS TaqMan HCV Test ≥ 20 weeks after the last dose of study medication. Participants were monitored up to 36 months.
Total Total of all reporting groups

Baseline Measures
    Resistance Monitoring Arm     SVR Durability Monitoring Arm     Total  
Number of Participants  
[units: participants]
  172     552     724  
Age  
[units: years]
Mean (Standard Deviation)
  52.1  (8.48)     51.0  (10.79)     51.2  (10.29)  
Gender  
[units: participants]
     
Female     47     222     269  
Male     125     330     455  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants With the Detectable HCV Ribonucleic Acid (RNA) Results in Resistance Monitoring Arm at Month 3   [ Time Frame: Month 3 ]

2.  Primary:   Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 6   [ Time Frame: Month 6 ]

3.  Primary:   Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 9   [ Time Frame: Month 9 ]

4.  Primary:   Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 12   [ Time Frame: Month 12 ]

5.  Primary:   Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 18   [ Time Frame: Month 18 ]

6.  Primary:   HCV RNA Levels in Resistance Monitoring Arm at Month 3   [ Time Frame: Month 3 ]

7.  Primary:   HCV RNA Levels in Resistance Monitoring Arm at Month 6   [ Time Frame: Month 6 ]

8.  Primary:   HCV RNA Levels in Resistance Monitoring Arm at Month 9   [ Time Frame: Month 9 ]

9.  Primary:   HCV RNA Levels in Resistance Monitoring Arm at Month 12   [ Time Frame: Month 12 ]

10.  Primary:   HCV RNA Levels in Resistance Monitoring Arm at Month 18   [ Time Frame: Month 18 ]

11.  Primary:   Mean Systolic Blood Pressure in Resistance Monitoring Arm at Month 3   [ Time Frame: Month 3 ]

12.  Primary:   Systolic Blood Pressure in Resistance Monitoring Arm at Month 6   [ Time Frame: Month 6 ]

13.  Primary:   Systolic Blood Pressure in Resistance Monitoring Arm at Month 9   [ Time Frame: Month 9 ]

14.  Primary:   Mean Systolic Blood Pressure in Resistance Monitoring Arm at Month 12   [ Time Frame: Month 12 ]

15.  Primary:   Mean Systolic Blood Pressure in Resistance Monitoring Arm at Month 18   [ Time Frame: Month 18 ]

16.  Primary:   Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 3   [ Time Frame: Month 3 ]

17.  Primary:   Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 6   [ Time Frame: Month 6 ]

18.  Primary:   Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 9   [ Time Frame: Month 9 ]

19.  Primary:   Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 12   [ Time Frame: Month 12 ]

20.  Primary:   Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 18   [ Time Frame: Month 18 ]

21.  Primary:   Mean Pulse Rate in Resistance Monitoring Arm at Month 3   [ Time Frame: Month 3 ]

22.  Primary:   Mean Pulse Rate in Resistance Monitoring Arm at Month 6   [ Time Frame: Month 6 ]

23.  Primary:   Mean Pulse Rate in Resistance Monitoring Arm at Month 9   [ Time Frame: Month 9 ]

24.  Primary:   Mean Pulse Rate in Resistance Monitoring Arm at Month 12   [ Time Frame: Month 12 ]

25.  Primary:   Mean Pulse Rate in Resistance Monitoring Arm at Month 18   [ Time Frame: Month 18 ]

26.  Primary:   Percentage of Participants Who Received Anti-HCV Medications in Resistance Monitoring Arm   [ Time Frame: Up to 18 months ]

27.  Primary:   Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 6   [ Time Frame: Month 6 ]

28.  Primary:   Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 12   [ Time Frame: Month 12 ]

29.  Primary:   Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 24   [ Time Frame: Month 24 ]

30.  Primary:   Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 36   [ Time Frame: Month 36 ]

31.  Primary:   Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 6   [ Time Frame: Month 6 ]

32.  Primary:   Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 12   [ Time Frame: Month 12 ]

33.  Primary:   Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 24   [ Time Frame: Month 24 ]

34.  Primary:   Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 36   [ Time Frame: Month 36 ]

35.  Primary:   Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 6   [ Time Frame: Month 6 ]

36.  Primary:   Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 12   [ Time Frame: Month 12 ]

37.  Primary:   Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 24   [ Time Frame: Month 24 ]

38.  Primary:   Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 36   [ Time Frame: Month 36 ]

39.  Primary:   Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 6   [ Time Frame: Month 6 ]

40.  Primary:   Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 12   [ Time Frame: Month 12 ]

41.  Primary:   Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 24   [ Time Frame: Month 24 ]

42.  Primary:   Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 36   [ Time Frame: Month 36 ]

43.  Primary:   Mean Pulse Rate in SVR Durability Monitoring Arm at Month 6   [ Time Frame: Month 6 ]

44.  Primary:   Mean Pulse Rate in SVR Durability Monitoring Arm at Month 12   [ Time Frame: Month 12 ]

45.  Primary:   Mean Pulse Rate in SVR Durability Monitoring Arm at Month 24   [ Time Frame: Month 24 ]

46.  Primary:   Mean Pulse Rate in SVR Durability Monitoring Arm at Month 36   [ Time Frame: Month 36 ]

47.  Primary:   Number of Participants With Danoprevir (DNV) Resistance Status-Population Sequencing   [ Time Frame: Month 3-18 ]

48.  Primary:   Number of Participants With DNV Resistance Status-Clonal Sequencing   [ Time Frame: Month 3-18 ]

49.  Primary:   Number of Participants With Boceprevir (BOC) or Telaprevir (TVR) Resistance Status-Population Sequencing   [ Time Frame: Month 3-18 ]

50.  Primary:   Number of Participants With BOC or TVR Resistance Status-Clonal Sequencing   [ Time Frame: Month 3-18 ]

51.  Primary:   Number of Participants With Setrobuvir (STV) Resistance Status-Population Sequencing   [ Time Frame: Month 3-18 ]

52.  Primary:   Number of Participants With STV Resistance Status-Clonal Sequencing   [ Time Frame: Month 3-18 ]

53.  Primary:   Number of Participants Who Had Received Mericitabine (MCB)-Based Regimen and Enrolled in NV22688   [ Time Frame: Month 18 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Investigators were notified of the early termination of study in Jan2015 due to the completion of assessment for resistance monitoring arm and were encouraged to complete scheduled visits until Apr2015 for participants enrolled in SVR durability arm.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
phone: 800-821-8590
e-mail: genentech@druginfo.com



Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01168856     History of Changes
Other Study ID Numbers: NV22688
2009-016560-36 ( EudraCT Number )
Study First Received: July 15, 2010
Results First Received: December 30, 2015
Last Updated: February 12, 2016
Health Authority: France: AFSSAPS