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Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Participants With Genotype 1 Chronic Hepatitis C Virus Infection and Cirrhosis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Infectious Diseases BVBA
ClinicalTrials.gov Identifier:
NCT02114151
First received: April 2, 2014
Last updated: March 7, 2016
Last verified: March 2016
History of Changes
Results First Received: January 21, 2016  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Hepatitis C Virus Infection
Interventions: Drug: Simeprevir
Drug: Sofosbuvir

  Participant Flow
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  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.
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Reporting Groups
  Description
Simeprevir Plus Sofosbuvir Participants received simeprevir 150 milligram (mg) in combination with sofosbuvir 400 mg once daily for 12 weeks.

Baseline Measures
   Simeprevir Plus Sofosbuvir 
Overall Participants Analyzed 
[Units: Participants]
 		 103 
Age 
[Units: Years]
Median (Full Range) 		 58 
 (29 to 69) 
Gender 
[Units: Participants]
 		 
Female   20 
Male   83 


  Outcome Measures
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1.  Primary:   Percentage of Participants With a Sustained Virologic Response (SVR) 12 Weeks After the Actual End of Treatment (EOT)   [ Time Frame: Week 24 ]
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2.  Secondary:   Percentage of Participants With a Sustained Virologic Response (SVR) 4 Weeks After the Actual End of Treatment (EOT)   [ Time Frame: Week 16 ]
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3.  Secondary:   Percentage of Participants With a Sustained Virologic Response (SVR) 24 Weeks After the Actual End of Treatment (EOT)   [ Time Frame: Week 36 ]
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4.  Secondary:   Percentage of Participants With On-treatment Virologic Response   [ Time Frame: Week 2, 4 and End of Treatment (Week 12) ]
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5.  Secondary:   Percentage of Participants With On-treatment Failure   [ Time Frame: Week 12 ]
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6.  Secondary:   Percentage of Participants With Viral Breakthrough   [ Time Frame: Up to End of Treatment (Week 12) ]
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7.  Secondary:   Percentage of Participants With Viral Relapse   [ Time Frame: During the Follow-up (Week 24) ]
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8.  Secondary:   Change From Baseline in Hepatitis C Symptom and Impact Questionnaire Version 4 (HCV-SIQv4) Overall Body System Score (OBSS) up to Follow-up Week 12   [ Time Frame: Baseline, Week 4, Week 12 and Follow-Up Week 12 ]
  Show Outcome Measure 8

9.  Secondary:   Change From Baseline in Fatigue Severity Score (FSS) up to Follow-up Week 24   [ Time Frame: Baseline, Week 12, Follow-up Week 12 and 24 ]
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10.  Secondary:   Percentage of Participants With Depression by Using Center for Epidemiologic Studies Depression Scale (CES-D)   [ Time Frame: Baseline, Week 12, Follow-up Week 12 and 24 ]
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11.  Secondary:   Change From Baseline in EuroQol 5 Dimension Questionnaire (EQ-5D) up to Follow-up Week 24   [ Time Frame: Baseline, Follow-up Week 12 and 24 ]
  Show Outcome Measure 11

12.  Secondary:   Number of Participants Not Achieving SVR Showing Emerging Mutation at Time of Failure in HCV NS3/4A Sequence and NS5B up to Follow-up Week 24   [ Time Frame: Baseline, Day 3, Week 1, 2, 3, 4, 8, 12, Follow-up Week 4, 12 and 24 ]
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  Serious Adverse Events
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  Other Adverse Events
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  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
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  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: Associate Director
Organization: Janssen Infectious Diseases - Diagnostics BVBA
e-mail: ClinicalTrialDisclosure@its.jnj.com



Responsible Party: Janssen Infectious Diseases BVBA
ClinicalTrials.gov Identifier: NCT02114151     History of Changes
Other Study ID Numbers: CR103431
TMC435HPC3018 ( Other Identifier: Janssen Infectious Diseases BVBA )
Study First Received: April 2, 2014
Results First Received: January 21, 2016
Last Updated: March 7, 2016