A Phase 2 study of Different Treatment Combinations of AL-335, odalasvir and simeprevir in subjects with chronic hepatitis C virus infection

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-naïve and Treatmentexperienced Subjects With Chronic Hepatitis C Virus Genotype 1, 2, 4, 5 and 6 Infection Without Cirrhosis.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-004200-38-DE

Enrollment

365

Registered

2016-05-02

Start date

2016-09-12

Completion date

Unknown

Last updated

2018-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis C virus infection. MedDRA version: 20.0 Level: PT Classification code 10019744 Term: Hepatitis C System Organ Class: 10021881 - Infections and infestations

Interventions

Product Name: JNJ-38733214-AAA (G034) Product Code: SMV Pharmaceutical Form: Capsule, hard INN or Proposed INN: simeprevir CAS Number: 923604-59-5 Current Sponsor code: SMV Other descriptive name: JNJ

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Documented chronic HCV infection: diagnosis of HCV infection >6 months before the first screening assessment, either by detectable HCV RNA, an HCV positive antibody test or presence of histological changes consistent with chronic hepatitis in a liver biopsy • All subjects must have HCV genotype 1, 2, 4, 5 or 6 infection, determined at screening • HCV RNA plasma levels >10,000 IU/mL • HCV treatment-naïve Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 342 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 23

Exclusion criteria

Exclusion criteria: • Co-infection with multiple HCV genotypes • Co-infection with HIV • Presence of cirrhosis • Prior exposure to an HCV DAA, either in combination with PegIFN or IFN-free • Any evidence of liver disease of non-HCV etiology • Evidence of hepatic decompensation (history or current clinical evidence of ascites, bleeding varices or hepatic encephalopathy) • Subjects with HCV genotype 3 infection.

Design outcomes

Primary

Measure	Time frame
Timepoint(s) of evaluation of this end point: 12 weeks after the EOT (Week 6 or 8);Secondary Objective: • evaluate safety and tolerability, SVR4 and SVR24, on-treatment viral kinetics, of a 6- and 8-week treatment regimen containing AL-335, ODV, and SMV in subjects without cirrhosis • evaluate incidence of on-treatment failure during treatment • evaluate incidence of viral relapse after treatment • assess changes from baseline in HCV NS3/4A, NS5A, and NS5B sequence in subjects not achieving SVR, • evaluate effect of the presence or absence of baseline HCV NS3/4A polymorphisms (including Q80K), NS5A polymorphisms and/or NS5B polymorphisms on treatment outcome • evaluate concordance between SVR4, SVR12, and SVR24, • evaluate PK of AL-335, ODV, SMV, and their metabolites in plasma, • evaluate relationship between population-derived exposure parameters of AL-335, ODV, and SMV with SVR12 and safety, • explore impact of HCV and treatment with AL-335+ODV+SMV on the Fatigue Severity Scale total score and 5-level EuroQol 5-Dimension Visual Analog Scale score.;Main Objective: Evaluate efficacy, ie, sustained virologic response 12 weeks after the end of treatment (SVR12), of a combination treatment with AL-335, ODV, and SMV for 6 and 8 weeks in chronic HCV genotype 1, 2, 4, 5, or 6 infected subjects without cirrhosis ;Primary end point(s): Percentage of Chronic HCV Infected Subjects who Achieve Sustained Virologic Response 12 weeks After the end of Treatment (EOT) (SVR12)	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: 12 weeks after the EOT (Week 6 or 8);Secondary Objective: • evaluate safety and tolerability, SVR4 and SVR24, on-treatment viral kinetics, of a 6- and 8-week treatment regimen containing AL-335, ODV, and SMV in subjects without cirrhosis • evaluate incidence of on-treatment failure during treatment • evaluate incidence of viral relapse after treatment • assess changes from baseline in HCV NS3/4A, NS5A, and NS5B sequence in subjects not achieving SVR, • evaluate effect of the presence or absence of baseline HCV NS3/4A polymorphisms (including Q80K), NS5A polymorphisms and/or NS5B polymorphisms on treatment outcome • evaluate concordance between SVR4, SVR12, and SVR24, • evaluate PK of AL-335, ODV, SMV, and their metabolites in plasma, • evaluate relationship between population-derived exposure parameters of AL-335, ODV, and SMV with SVR12 and safety, • explore impact of HCV and treatment with AL-335+ODV+SMV on the Fatigue Severity Scale total score and 5-level EuroQol 5-Dimension Visual Analog Scale score.;Main Objective: Evaluate efficacy, ie, sustained virologic response 12 weeks after the end of treatment (SVR12), of a combination treatment with AL-335, ODV, and SMV for 6 and 8 weeks in chronic HCV genotype 1, 2, 4, 5, or 6 infected subjects without cirrhosis ;Primary end point(s): Percentage of Chronic HCV Infected Subjects who Achieve Sustained Virologic Response 12 weeks After the end of Treatment (EOT) (SVR12)

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Secondary

Measure	Time frame
Secondary end point(s): • Percentage of Subjects with Sustained Virologic Response at 4 (SVR4) and 24 (SVR24) Weeks After EOT • Percentage of Subjects With Viral Relapse During Follow-up up to 24 Weeks After EOT • Percentage of Subjects With On-treatment Failure • Percentage of Subjects With Virologic Response • Time to Achieve Undetectable HCV RNA <LLOQ HCV RNA • Effect of Presence or Absence of Baseline NS5A, NS5B or NS3/4A Genes Polymorphisms on Treatment Outcome • Changes from Baseline in Amino Acid Sequence in the HCV NS3/4A, NS5A and NS5B Genes in Subjects, who did not Achieve SVR • Change from Baseline Over Time in 5-level EuroQol 5 Dimension (EQ5D5L) Visual Analog Scale (VAS) Score • Change from Baseline Over Time in Fatigue Severity Scale (FSS) Total Score • Percentage of Subjects with Clinically Significant Positive or Negative Change from Baseline in FSS Total and EQ5D5L VAS at Week 4, EOT (Week 6 or 8), Follow up Week 4, 12 and 24 • Duration of Clinically Significant Positive or Negative Response from Baseline in FSS Total and EQ5D5L VAS at Week 4, EOT (Week 6 or 8), Follow up Week 4, 12 and 24 • Predose (trough) Plasma Concentration (C0h) • Area Under the Curve From Time Zero to 24 Hours Postdose (AUC 24) • Number of Subjects with Adverse Events (AEs);Timepoint(s) of evaluation of this end point: Each secondary end point respectively: • 4 and 24 weeks after EOT • Up to Week 24 of follow-up • Up to 6 or 8 weeks depending upon the Treatment received • Up to 6 or 8 weeks (on-treatment) • Up to 24 weeks of follow-up • Baseline • Baseline up to 24 weeks of follow-up • Baseline up to 24 weeks of follow-up • Baseline up to 24 weeks of follow-up • Week 4, EOT, follow up Week 4, 12 and 24 • Week 4, EOT, follow up Week 4, 12 and 24 • Baseline (Day 1) up to EOT • Baseline (Day 1) up to EOT • Screening (Day 1) up to Week 38 (= Week 24 of Follow-up)	—

Measure

Time frame

Secondary end point(s): • Percentage of Subjects with Sustained Virologic Response at 4 (SVR4) and 24 (SVR24) Weeks After EOT • Percentage of Subjects With Viral Relapse During Follow-up up to 24 Weeks After EOT • Percentage of Subjects With On-treatment Failure • Percentage of Subjects With Virologic Response • Time to Achieve Undetectable HCV RNA <LLOQ HCV RNA • Effect of Presence or Absence of Baseline NS5A, NS5B or NS3/4A Genes Polymorphisms on Treatment Outcome • Changes from Baseline in Amino Acid Sequence in the HCV NS3/4A, NS5A and NS5B Genes in Subjects, who did not Achieve SVR • Change from Baseline Over Time in 5-level EuroQol 5 Dimension (EQ5D5L) Visual Analog Scale (VAS) Score • Change from Baseline Over Time in Fatigue Severity Scale (FSS) Total Score • Percentage of Subjects with Clinically Significant Positive or Negative Change from Baseline in FSS Total and EQ5D5L VAS at Week 4, EOT (Week 6 or 8), Follow up Week 4, 12 and 24 • Duration of Clinically Significant Positive or Negative Response from Baseline in FSS Total and EQ5D5L VAS at Week 4, EOT (Week 6 or 8), Follow up Week 4, 12 and 24 • Predose (trough) Plasma Concentration (C0h) • Area Under the Curve From Time Zero to 24 Hours Postdose (AUC 24) • Number of Subjects with Adverse Events (AEs);Timepoint(s) of evaluation of this end point: Each secondary end point respectively: • 4 and 24 weeks after EOT • Up to Week 24 of follow-up • Up to 6 or 8 weeks depending upon the Treatment received • Up to 6 or 8 weeks (on-treatment) • Up to 24 weeks of follow-up • Baseline • Baseline up to 24 weeks of follow-up • Baseline up to 24 weeks of follow-up • Baseline up to 24 weeks of follow-up • Week 4, EOT, follow up Week 4, 12 and 24 • Week 4, EOT, follow up Week 4, 12 and 24 • Baseline (Day 1) up to EOT • Baseline (Day 1) up to EOT • Screening (Day 1) up to Week 38 (= Week 24 of Follow-up)

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Countries

Belgium, Canada, Germany, Italy, Poland, Singapore, Spain

Contacts

Public ContactClinical Registry Group

Janssen-Cilag International NV (Janssen Biologics)

ClinicalTrialsEU@its.jnj.com+3171524-2166

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026