Clinical trial NCT02765490: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C, Chronic
Keywords: Hepatitis C, Chronic
AL-335
Odalasvir
Simeprevir
ODV
SMV
ACH-3102
ACH-0143102
TMC435
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2016-05-06
Enrollment: 365
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Percentage of Participants With Sustained Virologic Response 12 Weeks After End of Treatment (EOT) (SVR12)
timeFrame: Week 12 (Follow-Up Phase)
Secondary outcomes:
measure: Percentage of Participants With Sustained Virologic Response 24 Weeks After End of Treatment (SVR24)
timeFrame: Week 24 (Follow-Up Phase)
measure: Number of Participants With Viral Relapse
timeFrame: End of Treatment up to Week 24 (Follow up phase)
measure: Number of Participants With Late Viral Relapse
timeFrame: Up to Week 24 (Follow-up Phase)
measure: Percentage of Participants With On-treatment Failure
timeFrame: EOT up to Week 12 (Follow up Phase)
measure: Percentage of Participants With Sustained Virologic Response 4 Weeks After End of Treatment (EOT)
timeFrame: Week 4 (Follow-Up Phase)
Other outcomes:
Locations:
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
country: Canada
state: British Columbia
city: Victoria
country: Canada
state: British Columbia
city: Toronto
country: Canada
state: Ontario
city: Vaughan
country: Canada
state: Ontario
city: Monteral
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
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
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: