Efficacy and Safety of Combinations of AL-335, Odalasvir (ODV) and Simeprevir (SMV) in the Treatment of Chronic Hepatitis C Infection

November 19, 2019 updated by: Janssen Research & Development, LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

365

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Antwerpen, Belgium
      • Bruxelles, Belgium
      • Edegem, Belgium
      • Gent, Belgium
      • Kortrijik, Belgium
      • Leuven, Belgium
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
      • Victoria, British Columbia, Canada
    • Ontario
      • Toronto, Ontario, Canada
      • Vaughan, Ontario, 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 12 (Follow-Up Phase)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Week 24 (Follow-Up Phase)
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.
End of Treatment up to Week 24 (Follow up phase)
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.
Up to Week 24 (Follow-up Phase)
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).
EOT up to Week 12 (Follow up Phase)
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).
Week 4 (Follow-Up Phase)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Janssen Research & Development, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 9, 2016

Primary Completion (Actual)

August 9, 2017

Study Completion (Actual)

November 16, 2017

Study Registration Dates

First Submitted

May 5, 2016

First Submitted That Met QC Criteria

May 5, 2016

First Posted (Estimate)

May 6, 2016

Study Record Updates

Last Update Posted (Actual)

November 20, 2019

Last Update Submitted That Met QC Criteria

November 19, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR108070
  • 64294178HPC2001 (Other Identifier: Janssen Research & Development, LLC)
  • 2015-004200-38 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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