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Efficacy and Safety of Combinations of AL-335, Odalasvir (ODV) and Simeprevir (SMV) in the Treatment of Chronic Hepatitis C 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: NCT02765490
Recruitment Status : Completed
First Posted : May 6, 2016
Results First Posted : January 22, 2019
Last Update Posted : November 20, 2019
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Description
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Brief Summary:
The purpose of this study is to evaluate the efficacy (proportion of subjects with SVR12), safety, tolerability and pharmacokinetics of an 8- and 6-week treatment regimen of AL-335, odalasvir (ODV) and simeprevir (SMV) in chronic HCV genotype 1, 2, 4, 5 or 6 infected subjects without cirrhosis.

Condition or disease Intervention/treatment Phase
Hepatitis C, Chronic Drug: AL-335 Drug: Odalasvir Drug: Simeprevir Phase 2

Detailed Description:
This is a Phase 2b multicenter study. The study will include a screening period of maximum 6 weeks, a treatment period of 6 or 8 weeks and a 24-weeks post-treatment follow-up period. The total study duration for each subject will be 36 to 38 weeks. This study investigates a 3 direct-acting antiviral agent (DAA) combination of AL-335 (HCV NS5B inhibitor), odalasvir (ODV) (a second generation HCV NS5A inhibitor) and simeprevir (SMV) (HCV NS3A4 protease inhibitor). The results of this study will enable the selection of treatment and duration to be further developed.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 365 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2b, Multicenter, Randomized, Open-label Study to Investigate the Efficacy, Safety and Pharmacokinetics of Different Treatment Regimens of AL-335, Odalasvir, and Simeprevir in Treatment-naive and Treatment-experienced Subjects With Chronic Hepatitis C Virus Genotype 1, 2, 4, 5, and 6 Infection Without Cirrhosis
Actual Study Start Date : November 9, 2016
Actual Primary Completion Date : August 9, 2017
Actual Study Completion Date : November 16, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Simeprevir

Arms and Interventions
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Arm Intervention/treatment
Experimental: Group A
AL-335 (800 mg), odalasvir (25 mg) and simeprevir (75 mg) once daily during 6 weeks.
 Drug: AL-335
AL-335 800 mg (2*400) tablet will be administered once daily.

Drug: Odalasvir
Odalasvir 25 mg tablet will be administered once daily.

Drug: Simeprevir
Simeprevir 75 mg capsule will be administered once daily.
Experimental: Group B
AL-335 (800 mg), odalasvir (25 mg) and simeprevir (75 mg) once daily during 8 weeks.
 Drug: AL-335
AL-335 800 mg (2*400) tablet will be administered once daily.

Drug: Odalasvir
Odalasvir 25 mg tablet will be administered once daily.

Drug: Simeprevir
Simeprevir 75 mg capsule will be administered once daily.


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With Sustained Virologic Response 12 Weeks After End of Treatment (EOT) (SVR12) [ Time Frame: Week 12 (Follow-Up Phase) ]
    The SVR 12 was defined as 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 24 Weeks After End of Treatment (SVR24) [ Time Frame: Week 24 (Follow-Up Phase) ]
    The SVR24 was defined as HCV RNA <LLOQ (detectable or undetectable) 24 weeks after End of Treatment (EOT).

  2. Number of Participants With Viral Relapse [ Time Frame: End of Treatment up to Week 24 (Follow up phase) ]
    Viral Relapse: Participants who did not achieve SVR12, with HCV RNA <LLOQ at the EOT and confirmed HCV RNA greater than or equal to (>=) LLOQ during follow-up.

  3. Number of Participants With Late Viral Relapse [ Time Frame: Up to Week 24 (Follow-up Phase) ]
    Late Viral Relapse: Participants who achieved SVR12 but had confirmed HCV RNA>=LLOQ afterwards during follow-up.

  4. Percentage of Participants With On-treatment Failure [ Time Frame: EOT up to Week 12 (Follow up Phase) ]
    On-treatment failure: Participants who did not achieve SVR12 and with confirmed HCV RNA>=LLOQ at the End of Treatment (EOT).

  5. Percentage of Participants With Sustained Virologic Response 4 Weeks After End of Treatment (EOT) [ Time Frame: Week 4 (Follow-Up Phase) ]
    The SVR 4 was defined as participants were considered to have reached SVR4, if 4 weeks after the actual EOT, HCV RNA was <LLOQ (detectable or undetectable).


Eligibility Criteria
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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:

  • Individuals with chronic hepatitis C virus (HCV) genotype 1, 2, 4, 5 or 6 infection
  • Documented as treatment naive or experienced with a prior regimen consisting of Interferon (IFN) +/-Ribavirin (RBV) regimen without achieving sustained viral response
  • Absence of cirrhosis
  • Screening laboratory values within defined thresholds
  • Must use specific contraceptive methods if female of childbearing potential or sexually active male

Exclusion Criteria:

  • Co-infection with human immunodeficiency virus (HIV) or hepatitis B virus (HBV)
  • Prior exposure to an HCV direct-acting antiviral agent (DAA), either in combination with pegylated interferon (PegIFN) or IFN-free
  • Current or prior history of clinical hepatic decompensation
  • History of clinically significant illness or any other medical disorder including cardiovascular conditions that may interfere with individual's treatment, assessment or compliance with the protocol
  • Pregnant or a nursing female
Contacts and Locations
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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): NCT02765490


Locations
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Belgium
Antwerpen, Belgium
Bruxelles, Belgium
Edegem, Belgium
Gent, Belgium
Kortrijik, Belgium
Leuven, Belgium
Canada, British Columbia
Vancouver, British Columbia, Canada
Victoria, British Columbia, Canada
Canada, Ontario
Toronto, Ontario, Canada
Vaughan, Ontario, Canada
Canada, Quebec
Monteral, Quebec, Canada
Montreal, Quebec, Canada
Germany
Berlin, Germany
Essen, Germany
Frankfurt, Germany
Hamburg, Germany
Leipzig, Germany
Poland
Lodz, Poland
Lublin, Poland
Mysłowice, Poland
Warszawa, Poland
Wroclaw, Poland
Singapore
Singapore, Singapore
Spain
Barcelona, Spain
Madrid, Spain
Málaga, Spain
Seville, Spain
Valencia, Spain
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
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Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
  Study Documents (Full-Text)

Documents provided by Janssen Research & Development, LLC:
Study Protocol  [PDF] April 10, 2017
Statistical Analysis Plan  [PDF] June 27, 2017

More Information
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Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT02765490    
Other Study ID Numbers: CR108070
64294178HPC2001 ( Other Identifier: Janssen Research & Development, LLC )
2015-004200-38 ( EudraCT Number )
First Posted: May 6, 2016    Key Record Dates
Results First Posted: January 22, 2019
Last Update Posted: November 20, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Janssen Research & Development, LLC:
Hepatitis C, Chronic
AL-335
Odalasvir
Simeprevir
ODV
 SMV
ACH-3102
ACH-0143102
TMC435
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Infections
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
 Blood-Borne Infections
Communicable Diseases
Flaviviridae Infections
Hepatitis, Chronic
Simeprevir
Odalasvir
Antiviral Agents
Anti-Infective Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action