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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

Primary Purpose

Hepatitis C, Chronic

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
AL-335
Odalasvir
Simeprevir
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C, Chronic focused on measuring Hepatitis C, Chronic, AL-335, Odalasvir, Simeprevir, ODV, SMV, ACH-3102, ACH-0143102, TMC435

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group A

Group B

Arm Description

AL-335 (800 mg), odalasvir (25 mg) and simeprevir (75 mg) once daily during 6 weeks.

AL-335 (800 mg), odalasvir (25 mg) and simeprevir (75 mg) once daily during 8 weeks.

Outcomes

Primary Outcome Measures

Percentage of Participants With Sustained Virologic Response 12 Weeks After End of Treatment (EOT) (SVR12)
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

Percentage of Participants With Sustained Virologic Response 24 Weeks After End of Treatment (SVR24)
The SVR24 was defined as HCV RNA <LLOQ (detectable or undetectable) 24 weeks after End of Treatment (EOT).
Number of Participants With Viral Relapse
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.
Number of Participants With Late Viral Relapse
Late Viral Relapse: Participants who achieved SVR12 but had confirmed HCV RNA>=LLOQ afterwards during follow-up.
Percentage of Participants With On-treatment Failure
On-treatment failure: Participants who did not achieve SVR12 and with confirmed HCV RNA>=LLOQ at the End of Treatment (EOT).
Percentage of Participants With Sustained Virologic Response 4 Weeks After End of Treatment (EOT)
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).

Full Information

First Posted
May 5, 2016
Last Updated
November 19, 2019
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT02765490
Brief Title
Efficacy and Safety of Combinations of AL-335, Odalasvir (ODV) and Simeprevir (SMV) in the Treatment of Chronic Hepatitis C Infection
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
November 9, 2016 (Actual)
Primary Completion Date
August 9, 2017 (Actual)
Study Completion Date
November 16, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Chronic
Keywords
Hepatitis C, Chronic, AL-335, Odalasvir, Simeprevir, ODV, SMV, ACH-3102, ACH-0143102, TMC435

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
365 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Description
AL-335 (800 mg), odalasvir (25 mg) and simeprevir (75 mg) once daily during 6 weeks.
Arm Title
Group B
Arm Type
Experimental
Arm Description
AL-335 (800 mg), odalasvir (25 mg) and simeprevir (75 mg) once daily during 8 weeks.
Intervention Type
Drug
Intervention Name(s)
AL-335
Intervention Description
AL-335 800 mg (2*400) tablet will be administered once daily.
Intervention Type
Drug
Intervention Name(s)
Odalasvir
Intervention Description
Odalasvir 25 mg tablet will be administered once daily.
Intervention Type
Drug
Intervention Name(s)
Simeprevir
Intervention Description
Simeprevir 75 mg capsule will be administered once daily.
Primary Outcome Measure Information:
Title
Percentage of Participants With Sustained Virologic Response 12 Weeks After End of Treatment (EOT) (SVR12)
Description
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.
Time Frame
Week 12 (Follow-Up Phase)
Secondary Outcome Measure Information:
Title
Percentage of Participants With Sustained Virologic Response 24 Weeks After End of Treatment (SVR24)
Description
The SVR24 was defined as HCV RNA <LLOQ (detectable or undetectable) 24 weeks after End of Treatment (EOT).
Time Frame
Week 24 (Follow-Up Phase)
Title
Number of Participants With Viral Relapse
Description
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.
Time Frame
End of Treatment up to Week 24 (Follow up phase)
Title
Number of Participants With Late Viral Relapse
Description
Late Viral Relapse: Participants who achieved SVR12 but had confirmed HCV RNA>=LLOQ afterwards during follow-up.
Time Frame
Up to Week 24 (Follow-up Phase)
Title
Percentage of Participants With On-treatment Failure
Description
On-treatment failure: Participants who did not achieve SVR12 and with confirmed HCV RNA>=LLOQ at the End of Treatment (EOT).
Time Frame
EOT up to Week 12 (Follow up Phase)
Title
Percentage of Participants With Sustained Virologic Response 4 Weeks After End of Treatment (EOT)
Description
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).
Time Frame
Week 4 (Follow-Up Phase)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
City
Antwerpen
Country
Belgium
City
Bruxelles
Country
Belgium
City
Edegem
Country
Belgium
City
Gent
Country
Belgium
City
Kortrijik
Country
Belgium
City
Leuven
Country
Belgium
City
Vancouver
State/Province
British Columbia
Country
Canada
City
Victoria
State/Province
British Columbia
Country
Canada
City
Toronto
State/Province
Ontario
Country
Canada
City
Vaughan
State/Province
Ontario
Country
Canada
City
Monteral
State/Province
Quebec
Country
Canada
City
Montreal
State/Province
Quebec
Country
Canada
City
Berlin
Country
Germany
City
Essen
Country
Germany
City
Frankfurt
Country
Germany
City
Hamburg
Country
Germany
City
Leipzig
Country
Germany
City
Lodz
Country
Poland
City
Lublin
Country
Poland
City
Mysłowice
Country
Poland
City
Warszawa
Country
Poland
City
Wroclaw
Country
Poland
City
Singapore
Country
Singapore
City
Barcelona
Country
Spain
City
Madrid
Country
Spain
City
Málaga
Country
Spain
City
Seville
Country
Spain
City
Valencia
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

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