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3-year Follow-up Study in Patients Previously Treated With TMC435-Containing Regimen for the Treatment of Hepatitis C Virus Infection

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen R&D Ireland
ClinicalTrials.gov Identifier:
NCT01349465
First received: April 26, 2011
Last updated: March 10, 2017
Last verified: March 2017
Results First Received: December 23, 2016  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition: Hepatitis C
Intervention: Drug: No treatment

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
In total 250 participants were screened and among those 249 were enrolled into the study (200 participants with SVR and 49 participants with no SVR).

Reporting Groups
  Description
SVR at Last Post-Therapy Follow-up Visit of Previous Study Participants with sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb [NCT00882908, NCT00980330] or Phase III [NCT01289782, NCT01290679, NCT01281839] study.
No SVR at Last Post-Therapy Follow-up Visit of Previous Study Participants with no sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb [NCT00882908, NCT00980330] or Phase III [NCT01289782, NCT01290679, NCT01281839] study.

Participant Flow:   Overall Study
    SVR at Last Post-Therapy Follow-up Visit of Previous Study   No SVR at Last Post-Therapy Follow-up Visit of Previous Study
STARTED   200   49 
COMPLETED   182   27 
NOT COMPLETED   18   22 
Adverse Event                1                0 
Death                3                0 
Lost to Follow-up                10                1 
Withdrawal by Subject                4                2 
Subject Ineligible To Continue The Trial                0                19 



  Baseline Characteristics
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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.
No text entered.

Reporting Groups
  Description
SVR at Last Post-Therapy Follow-up Visit of Previous Study Participants with sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb [NCT00882908, NCT00980330] or Phase III [NCT01289782, NCT01290679, NCT01281839] study.
No SVR at Last Post-Therapy Follow-up Visit of Previous Study Participants with no sustained virologic response (SVR) at last post-therapy follow-up visit of the previous Phase IIb [NCT00882908, NCT00980330] or Phase III [NCT01289782, NCT01290679, NCT01281839] study.
Total Total of all reporting groups

Baseline Measures
   SVR at Last Post-Therapy Follow-up Visit of Previous Study   No SVR at Last Post-Therapy Follow-up Visit of Previous Study   Total 
Overall Participants Analyzed 
[Units: Participants]
 200   49   249 
Age 
[Units: Years]
Median (Full Range)
 52 
 (22 to 70) 
 56 
 (28 to 70) 
 53 
 (22 to 70) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      78  39.0%      17  34.7%      95  38.2% 
Male      122  61.0%      32  65.3%      154  61.8% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Percentage of Participants Maintaining SVR at the Last Available Visit   [ Time Frame: Last Available Visit (Month 36 for subjects completing the study) ]

2.  Primary:   Overall Percentage of Participants With Change in Sequence of HCV NS3/4A Region Over Time in Participants With Confirmed Detectable HCV RNA at the Last Visit of the Previous Study   [ Time Frame: Baseline and Month 36 ]

3.  Primary:   Percentage of Participants With Change in Sequence of HCV NS3/4A Region Over Time in Participants With Confirmed Detectable HCV RNA (With Q80K at Baseline) at the Last Visit of the Previous Study   [ Time Frame: Baseline and Month 36 ]

4.  Primary:   Percentage of Participants With Change in Sequence of HCV NS3/4A Region Over Time in Participants With Confirmed Detectable HCV RNA (Without Q80K at Baseline) at the Last Visit of the Previous Study   [ Time Frame: Baseline and Month 36 ]

5.  Secondary:   Percentage of Participants With Late Viral Relapse   [ Time Frame: End of study (at month 36) ]

6.  Secondary:   Number of Participants With Adverse Events (AEs) as a Measure of Safety and Tolerability   [ Time Frame: End of study (at month 36) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
No text entered.


  More Information
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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: Study Responsible Scientist
Organization: Janssen Research & Development, LLC
e-mail: ClinicalTrialDisclosure@its.jnj.com



Responsible Party: Janssen R&D Ireland
ClinicalTrials.gov Identifier: NCT01349465     History of Changes
Other Study ID Numbers: CR017365
TMC435HPC3002 ( Other Identifier: Janssen R&D Ireland )
2010-019843-20 ( EudraCT Number )
Study First Received: April 26, 2011
Results First Received: December 23, 2016
Last Updated: March 10, 2017