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- || Clinical, P2a data, Journal: JNJ-4178 (adafosbuvir, odalasvir, and simeprevir) in Japanese patients with chronic hepatitis C virus genotype 1 or 2 infection with or without compensated cirrhosis: the Phase IIa OMEGA-3 study. (Pubmed Central) - Oct 15, 2021
P2a
In HCV GT1- and GT2-infected Japanese patients, treatment with JNJ-4178 was well tolerated and resulted in 100% of patients achieving SVR12.
- || Clinical, Journal: JNJ-4178 (AL-335, Odalasvir, and Simeprevir) for 6 or 8 Weeks in Hepatitis C Virus-infected Patients without Cirrhosis: OMEGA-1. (Pubmed Central) - Jun 18, 2020
P2b
All randomized patients completed treatment. In HCV-infected patients, 6 and 8 weeks of treatment with JNJ-4178 resulted in SVR12 rates of 98.9% and 97.8%, respectively, and was well tolerated.
- | Clinical, PK/PD data, Journal, Combination therapy, Monotherapy: Population Pharmacokinetics of AL-335 and Its Two Main Metabolites (ALS-022399, ALS-022227) in Monotherapy and in Combination with Odalasvir and/or Simeprevir. (Pubmed Central) - Sep 26, 2019
Internal evaluation confirmed that the population pharmacokinetic model developed was deemed appropriate to describe the time course of AL-335, ALS-022399, and ALS-022227 plasma concentrations and their associated variability in both healthy and HCV-infected subjects, as well as the interaction effect of simeprevir and/or odalasvir over AL-335 and its metabolites in healthy subjects. This model can be used as a starting point to evaluate drug-drug interaction processes in HCV-infected patients and support the development of a direct-acting antiviral (DAA) combination.
- | Clinical, Journal: Short Duration AL-335, Odalasvir, With/Without Simeprevir, in Patients With HCV GT1 or 3 Infection Without Cirrhosis. (Pubmed Central) - Mar 25, 2019
In treatment-naïve subjects without cirrhosis, AL-335 + odalasvir + simeprevir for 6-8 weeks was generally safe and highly efficacious against HCV GT1. However, inadequate efficacy was observed for the 2-DAA regimen in GT1-infected subjects and the 3-DAA regimen in GT3-infected subjects.
- | Trial completion, Enrollment change: A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of the Combination of AL-335, Odalasvir, and Simeprevir (clinicaltrials.gov) - Jul 24, 2018
P2a, N=161, Completed, Sponsor: Alios Biopharma Inc.
However, inadequate efficacy was observed for the 2-DAA regimen in GT1-infected subjects and the 3-DAA regimen in GT3-infected subjects. Active, not recruiting --> Completed | N=320 --> 161
- || Trial completion: A Study to Investigate the Safety, Pharmacokinetics, and Efficacy of Combination Treatment of AL-335, Odalasvir, and Simeprevir in Japanese Participants With Chronic Hepatitis C Genotype 1 or 2 Virus Infection, With or Without Compensated Cirrhosis Who Are Direct Acting Antiviral Treatment-naive (clinicaltrials.gov) - Jun 18, 2018
P2a, N=33, Completed, Sponsor: Janssen Pharmaceutical K.K.
Active, not recruiting --> Completed | N=320 --> 161 Active, not recruiting --> Completed
- Enrollment change, Trial completion date, Trial termination, Trial primary completion date: A Long Term Follow-up Study in Participants Treated in a Preceding Phase 2 or 3 Study With a Regimen Containing Odalasvir and AL-335 With or Without Simeprevir for the Treatment of Hepatitis C Virus (HCV) Infection (clinicaltrials.gov) - Mar 27, 2018
P3, N=24, Terminated, Sponsor: Janssen Research & Development, LLC
Active, not recruiting --> Completed N=54 --> 24 | Trial completion date: Jan 2022 --> Feb 2018 | Recruiting --> Terminated | Trial primary completion date: Oct 2020 --> Feb 2018; Recruitment prematurely stopped based on decision to stop HPC program (not due to safety or efficacy results) + On 31 Jan 2018 decision to stop the study
- | Trial completion date, Trial initiation date, Trial primary completion date: A Study to Investigate the Safety, Pharmacokinetics, and Efficacy of Combination Treatment of AL-335, Odalasvir, and Simeprevir in Japanese Participants With Chronic Hepatitis C Genotype 1 or 2 Virus Infection, With or Without Compensated Cirrhosis Who Are Direct Acting Antiviral Treatment-naive (clinicaltrials.gov) - Mar 3, 2018
P2a, N=33, Active, not recruiting, Sponsor: Janssen Pharmaceutical K.K.
N=54 --> 24 | Trial completion date: Jan 2022 --> Feb 2018 | Recruiting --> Terminated | Trial primary completion date: Oct 2020 --> Feb 2018; Recruitment prematurely stopped based on decision to stop HPC program (not due to safety or efficacy results) + On 31 Jan 2018 decision to stop the study Trial completion date: May 2018 --> May 2018 | Initiation date: Jan 2017 --> Dec 2016 | Trial primary completion date: May 2018 --> May 2018
- Enrollment change, Trial termination, Trial primary completion date: Study to Assess the Relative Bioavailability of Fixed-Dose Combination (FDC) Tablet (Simeprevir, Odalasvir and AL-335) Compared With Single Agents Administered Together, and to Assess the Effect of Multiple-Dose Lansoprazole or Omeprazole on Single-Dose Pharmacokinetics of SMV, ODV, and AL-335 (FDC) (clinicaltrials.gov) - Dec 22, 2017
P1, N=72, Terminated, Sponsor: Janssen Research & Development, LLC
Trial completion date: May 2018 --> May 2018 | Initiation date: Jan 2017 --> Dec 2016 | Trial primary completion date: May 2018 --> May 2018 N=120 --> 72 | Recruiting --> Terminated | Trial primary completion date: Oct 2017 --> Apr 2017; Decision to discontinue development of investigational Hep C treatment regimen JNJ-4178: 3 direct acting antivirals - AL-335, ODV & SMV.
- |||| Trial completion: Efficacy and Safety of Combinations of AL-335, Odalasvir (ODV) and Simeprevir (SMV) in the Treatment of Chronic Hepatitis C Infection (clinicaltrials.gov) - Dec 5, 2017
P2b, N=365, Completed, Sponsor: Janssen Research & Development, LLC
N=120 --> 72 | Recruiting --> Terminated | Trial primary completion date: Oct 2017 --> Apr 2017; Decision to discontinue development of investigational Hep C treatment regimen JNJ-4178: 3 direct acting antivirals - AL-335, ODV & SMV. Active, not recruiting --> Completed
- Trial primary completion date: A Study to Investigate the Safety, Pharmacokinetics, and Efficacy of Combination Treatment of AL-335, Odalasvir, and Simeprevir in Japanese Participants With Chronic Hepatitis C Genotype 1 or 2 Virus Infection, With or Without Compensated Cirrhosis Who Are Direct Acting Antiviral Treatment-naive (clinicaltrials.gov) - Nov 21, 2017
P2a, N=33, Active, not recruiting, Sponsor: Janssen Pharmaceutical K.K.
Active, not recruiting --> Completed Trial primary completion date: Oct 2017 --> May 2018
- ||| Trial completion, Enrollment change: A Study to Evaluate the Cardiac Safety of a Single Dose of AL-335 Administered on a Background of Simeprevir and Odalasvir and of Repeated Doses of Odalasvir Administered Alone in Healthy Participants (clinicaltrials.gov) - Nov 14, 2017
P1, N=59, Completed, Sponsor: Janssen Research & Development, LLC
Trial primary completion date: Oct 2017 --> May 2018 Recruiting --> Completed | N=140 --> 59
- || Trial primary completion date: A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of the Combination of AL-335, Odalasvir, and Simeprevir (clinicaltrials.gov) - Nov 8, 2017
P2a, N=320, Active, not recruiting, Sponsor: Alios Biopharma Inc.
Recruiting --> Completed | N=140 --> 59 Trial primary completion date: Dec 2017 --> Jun 2018
- ||||| P2 data, Enrollment change, Trial primary completion date: A Long Term Follow-up Study in Participants Treated in a Preceding Phase 2 or 3 Study With a Regimen Containing Odalasvir and AL-335 With or Without Simeprevir for the Treatment of Hepatitis C Virus (HCV) Infection (clinicaltrials.gov) - Nov 8, 2017
P3, N=54, Recruiting, Sponsor: Janssen Research & Development, LLC
Trial primary completion date: Dec 2017 --> Jun 2018 N=250 --> 54 | Trial primary completion date: Dec 2021 --> Oct 2020
- ||| Enrollment closed: A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of the Combination of AL-335, Odalasvir, and Simeprevir (clinicaltrials.gov) - Oct 11, 2017
P2a, N=320, Active, not recruiting, Sponsor: Alios Biopharma Inc.
N=250 --> 54 | Trial primary completion date: Dec 2021 --> Oct 2020 Recruiting --> Active, not recruiting
- Enrollment change, Trial withdrawal, Combination therapy: A Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Odalasvir and AL-335 Alone and in Combination With Simeprevir in Participants With Moderately Impaired Hepatic Function (clinicaltrials.gov) - Oct 10, 2017
P1, N=0, Withdrawn, Sponsor: Janssen Research & Development, LLC
Recruiting --> Active, not recruiting N=16 --> 0 | Not yet recruiting --> Withdrawn
- | Enrollment closed: A Study to Investigate the Safety, Pharmacokinetics, and Efficacy of Combination Treatment of AL-335, Odalasvir, and Simeprevir in Japanese Participants With Chronic Hepatitis C Genotype 1 or 2 Virus Infection, With or Without Compensated Cirrhosis Who Are Direct Acting Antiviral Treatment-naive (clinicaltrials.gov) - Oct 10, 2017
P2a, N=33, Active, not recruiting, Sponsor: Janssen Pharmaceutical K.K.
N=16 --> 0 | Not yet recruiting --> Withdrawn Recruiting --> Active, not recruiting
- | New P1 trial, Combination therapy: A Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Odalasvir and AL-335 Alone and in Combination With Simeprevir in Participants With Moderately Impaired Hepatic Function (clinicaltrials.gov) - Sep 10, 2017
P1, N=16, Not yet recruiting, Sponsor: Janssen Research & Development, LLC
- || Trial primary completion date: A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of the Combination of AL-335, Odalasvir, and Simeprevir (clinicaltrials.gov) - Aug 15, 2017
P2a, N=320, Recruiting, Sponsor: Alios Biopharma Inc.
Recruiting --> Active, not recruiting Trial primary completion date: Jul 2017 --> Dec 2017
- || Enrollment change: A Study to Evaluate the Cardiac Safety of a Single Dose of AL-335 Administered on a Background of Simeprevir and Odalasvir and of Repeated Doses of Odalasvir Administered Alone in Healthy Participants (clinicaltrials.gov) - Aug 15, 2017
P1, N=140, Recruiting, Sponsor: Janssen Research & Development, LLC
Trial primary completion date: Jul 2017 --> Dec 2017 N=105 --> 140
- || Enrollment change: Study to Assess the Relative Bioavailability of Fixed-Dose Combination (FDC) Tablet (Simeprevir, Odalasvir and AL-335) Compared With Single Agents Administered Together, and to Assess the Effect of Multiple-Dose Lansoprazole or Omeprazole on Single-Dose Pharmacokinetics of SMV, ODV, and AL-335 (FDC) (clinicaltrials.gov) - Aug 15, 2017
P1, N=120, Recruiting, Sponsor: Janssen Research & Development, LLC
N=105 --> 140 N=90 --> 120
- || Trial primary completion date: Study to Assess the Relative Bioavailability of Fixed-Dose Combination (FDC) Tablet (Simeprevir, Odalasvir and AL-335) Compared With Single Agents Administered Together, and to Assess the Effect of Multiple-Dose Lansoprazole or Omeprazole on Single-Dose Pharmacokinetics of SMV, ODV, and AL-335 (FDC) (clinicaltrials.gov) - Jun 14, 2017
P1, N=90, Recruiting, Sponsor: Janssen Research & Development, LLC
N=90 --> 120 Trial primary completion date: May 2017 --> Oct 2017
- ||| Enrollment open: A Study to Evaluate the Cardiac Safety of a Single Dose of AL-335 Administered on a Background of Simeprevir and Odalasvir and of Repeated Doses of Odalasvir Administered Alone in Healthy Participants (clinicaltrials.gov) - May 30, 2017
P1, N=105, Recruiting, Sponsor: Janssen Research & Development, LLC
Trial primary completion date: May 2017 --> Oct 2017 Not yet recruiting --> Recruiting
- ||| Enrollment closed, Enrollment change: Efficacy and Safety of Combinations of AL-335, Odalasvir (ODV) and Simeprevir (SMV) in the Treatment of Chronic Hepatitis C Infection (clinicaltrials.gov) - May 30, 2017
P2b, N=366, Active, not recruiting, Sponsor: Janssen Research & Development, LLC
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting | N=300 --> 366
- ||| New P1 trial: A Study to Evaluate the Cardiac Safety of a Single Dose of AL-335 Administered on a Background of Simeprevir and Odalasvir and of Repeated Doses of Odalasvir Administered Alone in Healthy Participants (clinicaltrials.gov) - May 15, 2017
P1, N=105, Not yet recruiting, Sponsor: Janssen Research & Development, LLC
- |||||| Enrollment open, P2 data: A Long Term Follow-up Study in Participants Treated in a Preceding Phase 2 or 3 Study With a Regimen Containing Odalasvir and AL-335 With or Without Simeprevir for the Treatment of Hepatitis C Virus (HCV) Infection (clinicaltrials.gov) - May 3, 2017
P3, N=250, Recruiting, Sponsor: Janssen Research & Development, LLC
Recruiting --> Active, not recruiting | N=300 --> 366 Not yet recruiting --> Recruiting
- |||||||||| New P3 trial, P2 data: A Long Term Follow-up Study in Participants Treated in a Preceding Phase 2 or 3 Study With a Regimen Containing Odalasvir and AL-335 With or Without Simeprevir for the Treatment of Hepatitis C Virus (HCV) Infection (clinicaltrials.gov) - Apr 4, 2017
P3, N=250, Not yet recruiting, Sponsor: Janssen Research & Development, LLC
- ||| Enrollment open: Study to Assess the Relative Bioavailability of Fixed-Dose Combination (FDC) Tablet (Simeprevir, Odalasvir and AL-335) Compared With Single Agents Administered Together, and to Assess the Effect of Multiple-Dose Lansoprazole or Omeprazole on Single-Dose Pharmacokinetics of SMV, ODV, and AL-335 (FDC) (clinicaltrials.gov) - Mar 22, 2017
P1, N=90, Recruiting, Sponsor: Janssen Research & Development, LLC
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- ||| New P1 trial: Study to Assess the Relative Bioavailability of Fixed-Dose Combination (FDC) Tablet (Simeprevir, Odalasvir and AL-335) Compared With Single Agents Administered Together, and to Assess the Effect of Multiple-Dose Lansoprazole or Omeprazole on Single-Dose Pharmacokinetics of SMV, ODV, and AL-335 (FDC) (clinicaltrials.gov) - Feb 23, 2017
P1, N=90, Not yet recruiting, Sponsor: Janssen Research & Development, LLC
- | Enrollment open: A Study to Investigate the Safety, Pharmacokinetics, and Efficacy of Combination Treatment of AL-335, Odalasvir, and Simeprevir in Japanese Participants With Chronic Hepatitis C Genotype 1 or 2 Virus Infection, With or Without Compensated Cirrhosis Who Are Direct Acting Antiviral Treatment-naive (clinicaltrials.gov) - Feb 2, 2017
P2a, N=40, Recruiting, Sponsor: Janssen Pharmaceutical K.K.
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- ||| Phase classification, Enrollment change, Trial primary completion date: A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of the Combination of AL-335, Odalasvir, and Simeprevir (clinicaltrials.gov) - Jan 26, 2017
P2a, N=320, Recruiting, Sponsor: Alios Biopharma Inc.
Not yet recruiting --> Recruiting Phase classification: P2 --> P2a | N=140 --> 320 | Trial primary completion date: Jun 2016 --> Jul 2017
- | Trial completion, Combination therapy: To Evaluate the Effects of Odalasvir and AL-335 With Simeprevir on the Single-Dose Pharmacokinetics of Ethinylestradiol and Drospirenone in Healthy Female Participants (clinicaltrials.gov) - Jan 23, 2017
P1, N=24, Completed, Sponsor: Janssen Research & Development, LLC
Phase classification: P2 --> P2a | N=140 --> 320 | Trial primary completion date: Jun 2016 --> Jul 2017 Active, not recruiting --> Completed
- Enrollment closed, Combination therapy: To Evaluate the Effects of Odalasvir and AL-335 With Simeprevir on the Single-Dose Pharmacokinetics of Ethinylestradiol and Drospirenone in Healthy Female Participants (clinicaltrials.gov) - Dec 27, 2016
P1, N=24, Active, not recruiting, Sponsor: Janssen Research & Development, LLC
Active, not recruiting --> Completed Recruiting --> Active, not recruiting
- | New P2a trial: A Study to Investigate the Safety, Pharmacokinetics, and Efficacy of Combination Treatment of AL-335, Odalasvir, and Simeprevir in Japanese Participants With Chronic Hepatitis C Genotype 1 or 2 Virus Infection, With or Without Compensated Cirrhosis Who Are Direct Acting Antiviral Treatment-naive (clinicaltrials.gov) - Dec 15, 2016
P2a, N=40, Not yet recruiting, Sponsor: Janssen Pharmaceutical K.K.
- | Trial completion, Enrollment change: Study to Investigate the Pharmacokinetic Interaction Between 2 Direct Acting Antiviral Agents Odalasvir and AL-335 and Between 3 Direct Acting Antiviral Agents Simeprevir, Odalasvir and AL-335 at Steady State in Healthy Japanese Participants (clinicaltrials.gov) - Dec 1, 2016
P1, N=22, Completed, Sponsor: Janssen Research & Development, LLC
Recruiting --> Active, not recruiting Recruiting --> Completed | N=16 --> 22
- |||| Enrollment open: Efficacy and Safety of Combinations of AL-335, Odalasvir (ODV) and Simeprevir (SMV) in the Treatment of Chronic Hepatitis C Infection (clinicaltrials.gov) - Nov 28, 2016
P2b, N=300, Recruiting, Sponsor: Janssen Research & Development, LLC
Recruiting --> Completed | N=16 --> 22 Not yet recruiting --> Recruiting
- Enrollment open, Combination therapy: To Evaluate the Effects of Odalasvir and AL-335 With Simeprevir on the Single-Dose Pharmacokinetics of Ethinylestradiol and Drospirenone in Healthy Female Participants (clinicaltrials.gov) - Sep 29, 2016
P1, N=24, Recruiting, Sponsor: Janssen Research & Development, LLC
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- ||| Phase classification, Enrollment change, Trial initiation date, Trial primary completion date: Efficacy and Safety of Combinations of AL-335, Odalasvir (ODV) and Simeprevir (SMV) in the Treatment of Chronic Hepatitis C Infection (clinicaltrials.gov) - Sep 9, 2016
P2b, N=300, Not yet recruiting, Sponsor: Janssen Research & Development, LLC
Not yet recruiting --> Recruiting Phase classification: P2 --> P2b | N=400 --> 300 | Initiation date: Jun 2016 --> Nov 2016 | Trial primary completion date: Apr 2017 --> Jul 2017
- | New P1 trial, Combination therapy: To Evaluate the Effects of Odalasvir and AL-335 With Simeprevir on the Single-Dose Pharmacokinetics of Ethinylestradiol and Drospirenone in Healthy Female Participants (clinicaltrials.gov) - Aug 30, 2016
P1, N=24, Not yet recruiting, Sponsor: Janssen Research & Development, LLC
- | New P1 trial: Study to Investigate the Pharmacokinetic Interaction Between 2 Direct Acting Antiviral Agents Odalasvir and AL-335 and Between 3 Direct Acting Antiviral Agents Simeprevir, Odalasvir and AL-335 at Steady State in Healthy Japanese Participants (clinicaltrials.gov) - Jul 6, 2016
P1, N=16, Recruiting, Sponsor: Janssen Research & Development, LLC
- ||| Enrollment change: A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of the Combination of AL-335, Odalasvir, and Simeprevir (clinicaltrials.gov) - May 13, 2016
P2, N=140, Recruiting, Sponsor: Alios Biopharma Inc.
Phase classification: P2 --> P2b | N=400 --> 300 | Initiation date: Jun 2016 --> Nov 2016 | Trial primary completion date: Apr 2017 --> Jul 2017 N=60 --> 140
- ||||| New P2 trial: Efficacy and Safety of Combinations of AL-335, Odalasvir (ODV) and Simeprevir (SMV) in the Treatment of Chronic Hepatitis C Infection (clinicaltrials.gov) - May 6, 2016
P2, N=400, Not yet recruiting, Sponsor: Janssen Research & Development, LLC
- |||| Enrollment open, Trial primary completion date: A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of the Combination of AL-335, Odalasvir, and Simeprevir (clinicaltrials.gov) - Feb 1, 2016
P2, N=60, Recruiting, Sponsor: Alios Biopharma Inc.
N=60 --> 140 Not yet recruiting --> Recruiting | Trial primary completion date: Feb 2016 --> Jun 2016
- | Trial completion: A Study to Evaluate the Effect of ACH-3102 and Simeprevir on AL-335 Pharmacokinetics in Healthy Volunteers (clinicaltrials.gov) - Jan 29, 2016
P1, N=32, Completed, Sponsor: Alios Biopharma Inc.
Not yet recruiting --> Recruiting | Trial primary completion date: Feb 2016 --> Jun 2016 Recruiting --> Completed
- ||||| New P2 trial: A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of the Combination of AL-335, Odalasvir, and Simeprevir (clinicaltrials.gov) - Oct 7, 2015
P2, N=60, Not yet recruiting, Sponsor: Alios Biopharma Inc.
- | New P1 trial: A Study to Evaluate the Effect of ACH-3102 and Simeprevir on AL-335 Pharmacokinetics in Healthy Volunteers (clinicaltrials.gov) - Jul 31, 2015
P1, N=32, Recruiting, Sponsor: Alios Biopharma Inc.