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
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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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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 ]

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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 ]

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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.

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

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