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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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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
A total of 147 participants from the United States and Canada were Screened and 103 were enrolled into the study. All 103 participants who received at least 1 dose of study drug and so were included in intent to treat (ITT) population.

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

Participant Flow:   Overall Study
    Simeprevir Plus Sofosbuvir
STARTED   103 
COMPLETED   96 
NOT COMPLETED   7 
Death                1 
Lost to Follow-up                1 
Withdrawal by Subject                5 



  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
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 ]
  Show Outcome Measure 1

2.  Secondary:   Percentage of Participants With a Sustained Virologic Response (SVR) 4 Weeks After the Actual End of Treatment (EOT)   [ Time Frame: Week 16 ]
  Show Outcome Measure 2

3.  Secondary:   Percentage of Participants With a Sustained Virologic Response (SVR) 24 Weeks After the Actual End of Treatment (EOT)   [ Time Frame: Week 36 ]
  Show Outcome Measure 3

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 ]
  Show Outcome Measure 5

6.  Secondary:   Percentage of Participants With Viral Breakthrough   [ Time Frame: Up to End of Treatment (Week 12) ]
  Show Outcome Measure 6

7.  Secondary:   Percentage of Participants With Viral Relapse   [ Time Frame: During the Follow-up (Week 24) ]
  Show Outcome Measure 7

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 ]
  Show Outcome Measure 9

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 ]
  Show Outcome Measure 12


  Serious Adverse Events
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Time Frame Baseline up to End of Treatment (Week 36)
Additional Description No text entered.

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

Serious Adverse Events
    Simeprevir Plus Sofosbuvir
Total, Serious Adverse Events   
# participants affected / at risk   5/103 (4.85%) 
Blood and lymphatic system disorders   
Anaemia * 1   
# participants affected / at risk   1/103 (0.97%) 
General disorders   
Non-cardiac chest pain * 1   
# participants affected / at risk   1/103 (0.97%) 
Infections and infestations   
Cellulitis * 1   
# participants affected / at risk   1/103 (0.97%) 
Sepsis * 1   
# participants affected / at risk   1/103 (0.97%) 
Injury, poisoning and procedural complications   
Limb injury * 1   
# participants affected / at risk   1/103 (0.97%) 
Road traffic accident * 1   
# participants affected / at risk   1/103 (0.97%) 
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA Version 17.1




  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
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: 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