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Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Subjects With Chronic Genotype 4 Hepatitis C Virus Infection

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.
 
ClinicalTrials.gov Identifier: NCT02250807
Recruitment Status : Completed
First Posted : September 26, 2014
Results First Posted : November 17, 2016
Last Update Posted : November 17, 2016
Sponsor:
Information provided by (Responsible Party):
Janssen R&D Ireland

Brief Summary:
The purpose of this study is to show superiority of simeprevir (SMV) in combination with sofosbuvir for 12 weeks versus a historical control. Historical control will be a composite of the observed historical sustained virological response at Week 12 (SVR12) rates of SMV in combination with (pegylated) interferon (PegIFN)/ribavirin (RBV) of the subpopulations in study HPC3011 (NCT01567735) and will depend on the percentage of treatment-naive, prior relapser, prior non-responder, interferon (IFN)-intolerant and other subjects enrolled in this study.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Genotype 4 Chronic Hepatitis C Drug: Simeprevir Drug: Sofosbuvir Phase 3

Detailed Description:
This is a Phase 3, open-label (all people know the identity of the intervention), single-arm, multicenter study (conducted at multiple sites). The study consists of 3 periods: a Screening period (up to 4 weeks), Treatment period (12 Weeks) and Post treatment follow-up period (until 24 weeks after end of treatment). The duration of the subjects' participation will be approximately 40 weeks. In the treatment period subjects will receive oral capsule simeprevir along with oral tablet sofosbuvir once daily for 12 weeks. Primarily efficacy will be evaluated as percentage of subjects with sustained virologic response at Week 12 after the end of treatment. Subjects' safety will be monitored throughout the study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Open-Label, Single-Arm Study to Investigate the Efficacy and Safety of a 12-Week Regimen of Simeprevir in Combination With Sofosbuvir in Treatment-Naive or -Experienced Subjects With Chronic Genotype 4 Hepatitis C Virus Infection
Study Start Date : January 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Simeprevir and Sofosbuvir
Subjects will receive oral capsule of Simeprevir 150 milligram (mg) along with oral tablet of sofosbuvir 400 mg, once a day from Day 1 up to Week 12.
Drug: Simeprevir
Subjects will receive oral capsule of Simeprevir 150 mg, once a day from Day 1 up to Week 12.
Other Name: TMC435

Drug: Sofosbuvir
Subjects will receive oral tablet of sofosbuvir 400 mg, once a day from Day 1 up to Week 12.




Primary Outcome Measures :
  1. Percentage of Participants With Sustained Virologic Response 12 Weeks After End of Treatment (EOT) (SVR12) [ Time Frame: 12 weeks after EOT ]
    SVR12 is defined as the percentage of participants with hepatitis C virus ribonucleic acid (HCV RNA) less than (<) lower limit of quantification (LLOQ; 15 international unit per milliliter [IU/mL]) detectable or undetectable 12 weeks after actual EOT.


Secondary Outcome Measures :
  1. Percentage of Participants With Sustained Virologic Response 4 Weeks After End of Therapy (SVR4) [ Time Frame: 4 weeks after EOT ]
    SVR4 is defined as the percentage of participants with hepatitis C virus ribonucleic acid (HCV RNA) less than (<) lower limit of quantification (LLOQ; 15 international unit per milliliter [IU/mL]) detectable or undetectable 4 weeks after actual EOT.

  2. Percentage of Participants With Sustained Virologic Response 24 Weeks After End of Therapy (SVR24) [ Time Frame: At 24 weeks after EOT ]
    Participants were considered to have reached SVR24, if at the time point of SVR24 (that is [i.e.], 24 weeks after the end of treatment [EOT]) the following condition has been met: HCV RNA < lower limit of quantification (LLOQ), i.e., 15 IU/mL, detectable or undetectable.

  3. Percentage of Participants With On-treatment Virologic Response of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) [ Time Frame: Week 2, 3, 4, 12 and EOT ]
    Percentage of participants with HCV RNA less than (<) 15 IU/mL undetectable or detectable or detectable /undetectable at specific time points were observed.

  4. Percentage of Participants With On-Treatment Failure [ Time Frame: through 12 weeks (EOT) ]
    Participants were considered on-treatment failures if they have at EOT (confirmed) detectable HCV RNA, i.e., <LLOQ detectable or >=LLOQ.

  5. Percentage of Participants With Viral Breakthrough [ Time Frame: Up to follow-up Week 24 ]
    Participants with confirmed >1.0 log10 increase in HCV RNA from nadir or confirmed HCV RNA >100 IU/mL in participants who had previously achieved HCV RNA <LLOQ.

  6. Percentage of Participants With Viral Relapse [ Time Frame: Up to follow-up week 24 ]
    Participants were considered to have viral relapse if they did not achieve SVR12 and meet the following conditions: 1) at EOT, HCV RNA less than (<)LLOQ, undetectable, and 2) during the follow-up period, HCV RNA greater than or equal to (>=)LLOQ.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects with confirmed hepatitis C virus (HCV) with HCV RNA greater than (>) 10000 international unit per milliliter (IU/mL)
  • Subjects who are treatment naive or treatment-experienced.
  • Subjects must have documentation of a liver biopsy or fibroscan or agree to have one during screening
  • Subjects with cirrhosis must have an hepatic imaging procedure (ultrasound, CT scan or magnetic resonance imaging [MRI]) within 6 months before the screening visit (or during the screening period) with no findings suspicious for hepatocellular carcinoma (HCC)
  • Women of childbearing potential or men with a female partner of childbearing potential must agree to use an effective form of contraception, or not be heterosexually active, or of nonchildbearing potential

Exclusion Criteria:

  • Evidence of clinical hepatic decompensation
  • Any liver disease of non-HCV etiology
  • Subjects with a past history of treatment with an approved or investigational DAA
  • Co-infection with human immunodeficiency virus (HIV) type 1 or type 2 (HIV-1 or HIV-2) (positive HIV-1 or HIV-2 antibodies test at screening)
  • Infection/co-infection with HCV non-genotype 4

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02250807


Locations
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Spain
Badalona, Spain
Barcelona, Spain
Madrid, Spain
Santander N/A, Spain
Sevilla N/A, Spain
Sevilla, Spain
Valencia, Spain
Sponsors and Collaborators
Janssen R&D Ireland
Investigators
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Study Director: Janssen R&D Ireland Clinical Trials Janssen R&D Ireland

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Janssen R&D Ireland
ClinicalTrials.gov Identifier: NCT02250807    
Obsolete Identifiers: NCT02256176
Other Study ID Numbers: CR105429
TMC435HPC3021 ( Other Identifier: Janssen R&D Ireland )
2014-003446-27 ( EudraCT Number )
First Posted: September 26, 2014    Key Record Dates
Results First Posted: November 17, 2016
Last Update Posted: November 17, 2016
Last Verified: September 2016
Keywords provided by Janssen R&D Ireland:
Chronic hepatitis C
Genotype 4 chronic hepatitis C
Simeprevir
Sofosbuvir
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Hepatitis, Chronic
Virus Diseases
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Sofosbuvir
Simeprevir
Antiviral Agents
Anti-Infective Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action