We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    TIBOTEC TIDP16 c206
Previous Study | Return to List | Next Study

A Safety and Effectiveness Study of TMC435 in Chronic, Genotype 1, Hepatitis C Patients Who Failed to Previous Standard Treatment (ASPIRE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00980330
First Posted: September 21, 2009
Last Update Posted: June 9, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Tibotec Pharmaceuticals, Ireland
Results First Submitted: December 18, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Hepatitis C
Interventions: Drug: TMC435
Drug: Placebo
Drug: Peg-IFN-alfa-2a (P)
Drug: Ribavirin (R)

  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
The study was conducted at 89 sites in 14 countries.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 618 participants were screened. Of these, 463 participants were randomized of whom 462 participants started treatment. One participant in the placebo group was 'randomized in error,' did not receive treatment, and was withdrawn from the study due to non-compliance (did not come for visit).

Reporting Groups
  Description
TMC435 100mg 12 Wks + PR48 Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
TMC435 100mg 24 Wks + PR48 Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
TMC435 100mg 48 Wks + PR48 Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
TMC435 150mg 12 Wks + PR48 Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
TMC435 150mg 24 Wks + PR48 Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
TMC435 150mg 48 Wks + PR48 Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
Placebo 48Wks + PR48 Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.

Participant Flow:   Overall Study
    TMC435 100mg 12 Wks + PR48   TMC435 100mg 24 Wks + PR48   TMC435 100mg 48 Wks + PR48   TMC435 150mg 12 Wks + PR48   TMC435 150mg 24 Wks + PR48   TMC435 150mg 48 Wks + PR48   Placebo 48Wks + PR48
STARTED   66   65   66   66   68   65   66 
COMPLETED   61   60   58   61   63   61   59 
NOT COMPLETED   5   5   8   5   5   4   7 
Adverse Event                0                0                0                1                0                0                0 
Lost to Follow-up                1                1                4                2                1                1                2 
Withdrawal by Subject                2                4                4                1                3                2                5 
(not specified)                2                0                0                1                1                1                0 



  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.
No text entered.

Reporting Groups
  Description
TMC435 100mg 12 Wks + PR48 Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo with PR for 36 weeks.
TMC435 100mg 24 Wks + PR48 Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed by Placebo with PR for 24 weeks.
TMC435 100mg 48 Wks + PR48 Participants received TMC435 100 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
TMC435 150mg 12 Wks + PR48 Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 12 weeks followed by Placebo and PR for 36 weeks.
TMC435 150mg 24 Wks + PR48 Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 24 weeks followed Placebo and PR for 24 weeks.
TMC435 150mg 48 Wks + PR48 Participants received TMC435 150 mg once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
Placebo 48Wks + PR48 Participants received Placebo once daily with Peg-IFN-alfa-2a (P) once weekly and ribavirin (R) twice daily for 48 weeks.
Total Total of all reporting groups

Baseline Measures
   TMC435 100mg 12 Wks + PR48   TMC435 100mg 24 Wks + PR48   TMC435 100mg 48 Wks + PR48   TMC435 150mg 12 Wks + PR48   TMC435 150mg 24 Wks + PR48   TMC435 150mg 48 Wks + PR48   Placebo 48Wks + PR48   Total 
Overall Participants Analyzed 
[Units: Participants]
 66   65   66   66   68   65   66   462 
Age 
[Units: Years]
Median (Full Range)
 51.5 
 (20 to 68) 
 50 
 (20 to 68) 
 50 
 (22 to 69) 
 48 
 (20 to 63) 
 51.5 
 (25 to 68) 
 50 
 (21 to 69) 
 50.5 
 (22 to 66) 
 50 
 (20 to 69) 
Gender 
[Units: Participants]
               
Female   22   21   21   21   25   17   24   151 
Male   44   44   45   45   43   48   42   311 
Region of Enrollment 
[Units: Participants]
               
Asia Pacific   4   5   4   4   1   4   7   29 
Europe and Israel   34   46   46   49   49   43   46   313 
North-America   28   14   16   13   18   18   13   120 
Prior PR response [1] 
[Units: Participants]
               
Null responder   16   16   18   17   17   17   16   117 
Partial responder   23   23   22   23   24   22   23   160 
Relapser   27   26   26   26   27   26   27   185 
[1] In the study, “Null Responders” were participants with less than 2 log10 IU/mL reduction in HCV RNA compared to baseline at Week 12 of the previous PegIFNα-2a/b and RBV treatment; “Partial Responders” were participants with a greater than or equal to 2 log10 IU/mL reduction in HCV RNA compared to baseline at Week 12, but not achieving an undetectable HCV RNA at the end of the previous PegIFNα-2a/b and RBV treatment; and “Relapsers” were participants with HCV RNA undetectable at end of the previous treatment with PegIFNα-2a/b and RBV, but detectable HCV RNA within 24 weeks of follow-up.
Metavir Score [1] 
[Units: Participants]
               
Not reported   1   2   0   0   1   1   2   7 
Score F0   6   3   6   5   11   1   7   39 
Score F1   17   14   23   19   11   27   18   129 
Score F2   21   17   9   18   21   16   16   118 
Score F3   14   16   14   11   11   7   13   86 
Score F4   7   13   14   13   13   13   10   83 
[1] A Metavir score is used to interpret the degree of inflammation and fibrosis in a liver biopsy. Below are fibrosis scores graded on a 5-point scale from F0 (no fibrosis) to F4 (cirrhosis).


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   The Percentage of Participants Achieving a Sustained Virologic Response at the End of Treatment (EOT) and 24 Weeks After the EOT (SVR24)   [ Time Frame: Week 72 ]

2.  Secondary:   The Percentage of Participants With a Greater Than 2 log10 Drop in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Time Points During Treatment   [ Time Frame: Weeks, 2, 4, 8, and 12 ]

3.  Secondary:   The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-up   [ Time Frame: Weeks, 2, 4, 8, 12, 24, 36, 48, 60, 72 and EOT (up to Week 48) ]

4.  Secondary:   The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-up   [ Time Frame: Weeks, 2, 4, 8, 12, 24, 36, 48, 60, 72, and EOT (up to Week 48) ]

5.  Secondary:   The Percentage of Participants Achieving a Rapid Virologic Response (RVR)   [ Time Frame: Week 4 ]

6.  Secondary:   The Percentage of Participants Achieving an Early Virologic Response (EVR)   [ Time Frame: Week 12 ]

7.  Secondary:   The Percentage of Participants Achieving a Complete Early Virologic Response (cEVR)   [ Time Frame: Week 12 ]

8.  Secondary:   The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12)   [ Time Frame: Week 60 ]

9.  Secondary:   The Percentage of Participants With Viral Breakthrough   [ Time Frame: EOT (up to Week 48) ]

10.  Secondary:   The Percentage of Participants With Viral Relapse   [ Time Frame: Up to Week 72 ]

11.  Secondary:   The Number of Participants Who Achieved Normalized Alanine Aminotransferase (ALT) Levels at the End of Treatment (EOT)   [ Time Frame: EOT (up to Week 48) ]

12.  Secondary:   Plasma Concentrations of TMC435   [ Time Frame: 0 (predose, baseline) and 4, 8, 12, and 24 hours post-dose at Weeks 2, 4, 8, 12, 16, 24, and 48 ]

13.  Secondary:   Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24h) for TMC435   [ Time Frame: 0 (predose, baseline) and 4, 8, 12, and 24 hours post-dose at Weeks 2, 4, 8, 12, 16, 24, and 48 ]


  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
No text entered.


  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 Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Global Clinical Development Manager
Organization: Jan-Cil France
e-mail: ClinicalTrialDisclosure@its.jnj.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Tibotec Pharmaceuticals, Ireland
ClinicalTrials.gov Identifier: NCT00980330     History of Changes
Other Study ID Numbers: CR016063
TMC435-TiDP16-C206 ( Other Identifier: Tibotec Pharmaceuticals, Ireland )
2009-010590-20 ( EudraCT Number )
First Submitted: September 10, 2009
First Posted: September 21, 2009
Results First Submitted: December 18, 2013
Results First Posted: February 6, 2014
Last Update Posted: June 9, 2014