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36 Diseases |  |
5 Trials |
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5 Trials |  |
637 News |  |
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- || 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.
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
- | Olysio (simeprevir) / J&J, Medivir
Trial completion, Combination therapy: Randomized Clinical Trial of Sofosbuvir in Combination With Daclatasvir or Simeprevir for 12 Weeks in Non-cirrhotic Subjects Infected With Chronic Hepatitis C Virus Genotype 1 (TNT) (clinicaltrials.gov) - Aug 1, 2017
P4, N=121, Completed, Sponsor: Federal University of S
N=90 --> 120 Active, not recruiting --> Completed
- || 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
Active, not recruiting --> Completed 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
- | odalasvir (ACH-3102) / J&J, AstraZeneca, Olysio (simeprevir) / J&J, Medivir
Trial completion, Combination therapy: A Pharmacokinetic Interaction Study Between Odalasvir, Given as a Single Agent or in Combination With Simeprevir, and Dabigatran Etexilate Mesylate in Healthy Participants (clinicaltrials.gov) - May 3, 2017
P1, N=15, Completed, Sponsor: Janssen Research & Development, LLC
Recruiting --> Active, not recruiting | N=300 --> 366 Recruiting --> Completed
- |||||| Enrollment open: 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 2, 2017
P3, N=250, Recruiting, Sponsor: Janssen Research & Development, LLC
Recruiting --> Completed Not yet recruiting --> Recruiting
- |||||||||| New P3 trial: 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
- | Trial primary completion date: Impact of Antiviral Therapy on Gastroesophageal Varices. (clinicaltrials.gov) - Mar 30, 2017
P=N/A, N=374, Active, not recruiting, Sponsor: Parc de Salut Mar
Not yet recruiting --> Recruiting Trial primary completion date: Jun 2016 --> Jun 2017
- ||| 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
Trial primary completion date: Jun 2016 --> Jun 2017 Not yet recruiting --> Recruiting
- | Olysio (simeprevir) / J&J, Medivir
New P4 trial: Sofosbuvir and Simeprevir Versus Sofosbuvir and Ribavirin in Treatment of HCV (clinicaltrials.gov) - Mar 3, 2017
P4, N=90, Completed, Sponsor: Ain Shams University
- ||| 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
- | Olysio (simeprevir) / J&J, Medivir
Enrollment closed, Enrollment change, Trial primary completion date, Combination therapy: Randomized Clinical Trial of Sofosbuvir in Combination With Daclatasvir or Simeprevir for 12 Weeks in Non-cirrhotic Subjects Infected With Chronic Hepatitis C Virus Genotype 1 (TNT) (clinicaltrials.gov) - Feb 20, 2017
P4, N=106, Active, not recruiting, Sponsor: Federal University of S
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting | N=394 --> 106 | Trial primary completion date: Dec 2016 --> Mar 2017
- | 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.
Recruiting --> Active, not recruiting | N=394 --> 106 | Trial primary completion date: Dec 2016 --> Mar 2017 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
- Pegasys (pegylated interferon ? -2a) / Roche, Sunvepra (asunaprevir) / BMS, Olysio (simeprevir) / J&J, Medivir
Trial primary completion date: SWITCH-1: Switching Regimen in Treating Cirrhotic HCV GT1b Subjects (clinicaltrials.gov) - Jan 18, 2017
P2, N=160, Recruiting, Sponsor: Humanity & Healthy GI and Liver Centre
Active, not recruiting --> Completed Trial primary completion date: Dec 2016 --> Dec 2017
- 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
Trial primary completion date: Dec 2016 --> Dec 2017 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.
- | Sovaldi (sofosbuvir) / Gilead
New P4 trial: Safety and Efficacy of Sofosbuvir-Based Regimens in the Treatment of Egyptian Patients With Hepatitis C Infection (clinicaltrials.gov) - Dec 14, 2016
P4, N=1000, Recruiting, Sponsor: Tanta University
- odalasvir (ACH-3102) / J&J, AstraZeneca, Olysio (simeprevir) / J&J, Medivir
Enrollment open, Combination therapy: A Pharmacokinetic Interaction Study Between Odalasvir, Given as a Single Agent or in Combination With Simeprevir, and Dabigatran Etexilate Mesylate in Healthy Participants (clinicaltrials.gov) - Dec 13, 2016
P1, N=15, Recruiting, Sponsor: Janssen Research & Development, LLC
Recruiting --> Active, not recruiting Not yet recruiting --> Recruiting
- | 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
Not yet recruiting --> 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
- Olysio (simeprevir) / J&J, Medivir, Tivicay (dolutegravir) / ViiV Healthcare
Trial completion: Drug Interaction Potential Between Dolutegravir and Simeprevir in HIV/HCV Seronegative Volunteers (clinicaltrials.gov) - Nov 22, 2016
P=N/A, N=25, Completed, Sponsor: University of Colorado, Denver
Not yet recruiting --> Recruiting Recruiting --> Completed
- | odalasvir (ACH-3102) / J&J, AstraZeneca, Olysio (simeprevir) / J&J, Medivir
New P1 trial, Combination therapy: A Pharmacokinetic Interaction Study Between Odalasvir, Given as a Single Agent or in Combination With Simeprevir, and Dabigatran Etexilate Mesylate in Healthy Participants (clinicaltrials.gov) - Oct 26, 2016
P1, N=15, Not yet recruiting, Sponsor: Janssen Research & Development, LLC
- Trial primary completion date: Real-life Security and Efficacy of DAA-based Therapy in HCV/HIV-Coinfected Patients (clinicaltrials.gov) - Oct 17, 2016
P=N/A, N=1000, Recruiting, Sponsor: Valme University Hospital
Recruiting --> Completed Trial primary completion date: Dec 2017 --> Dec 2020
- Trial primary completion date: GEHEP: Efficacy and Safety of Therapy Against HCV Based on Direct-acting Antivirals in Real-life Conditions (clinicaltrials.gov) - Oct 17, 2016
P=N/A, N=1000, Recruiting, Sponsor: Valme University Hospital
Trial primary completion date: Dec 2017 --> Dec 2020 Trial primary completion date: Nov 2017 --> Nov 2020
- | Olysio (simeprevir) / J&J, Medivir
Phase classification, Combination therapy: An Efficacy and Safety Study of a 8 or 12-Week Treatment Regimen of Simeprevir in Combination With Sofosbuvir in Treatment-Naive and Experienced Participants With Chronic Genotype 4 Hepatitis C Virus Infection (clinicaltrials.gov) - Oct 14, 2016
P2a, N=63, Completed, Sponsor: Janssen-Cilag International NV
Trial primary completion date: Nov 2017 --> Nov 2020 Phase classification: P2 --> P2a
- |||| Olysio (simeprevir) / J&J, Medivir
Trial completion, Enrollment change, Trial primary completion date: Safety, Tolerability, and Efficacy of 24 Weeks Simeprevir+Sofosbuvir for Chronic Hepatitis C Genotype 1 (clinicaltrials.gov) - Oct 13, 2016
P4, N=60, Completed, Sponsor: Stanford University
Phase classification: P2 --> P2a Not yet recruiting --> Completed | N=30 --> 60 | Trial primary completion date: Oct 2017 --> Aug 2016
- Olysio (simeprevir) / J&J, Medivir
Trial primary completion date: Reversal of Hepatic Impairment in Patients With Hepatitis C Virus (HCV) and Early Decompensation of Cirrhosis (clinicaltrials.gov) - Oct 11, 2016
P3, N=9, Active, not recruiting, Sponsor: University of Colorado, Denver
Not yet recruiting --> Completed | N=30 --> 60 | Trial primary completion date: Oct 2017 --> Aug 2016 Trial primary completion date: Aug 2016 --> Dec 2017
- 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
Trial primary completion date: Aug 2016 --> Dec 2017 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
- Pegasys (pegylated interferon ? -2a) / Roche, Sunvepra (asunaprevir) / BMS, Olysio (simeprevir) / J&J, Medivir
Trial primary completion date: SWITCH-1: Switching Regimen in Treating Cirrhotic HCV GT1b Subjects (clinicaltrials.gov) - Aug 22, 2016
P2, N=160, Recruiting, Sponsor: Humanity & Healthy GI and Liver Centre
Phase classification: P2 --> P2b | N=400 --> 300 | Initiation date: Jun 2016 --> Nov 2016 | Trial primary completion date: Apr 2017 --> Jul 2017 Trial primary completion date: Sep 2016 --> Dec 2016
- | Olysio (simeprevir) / J&J, Medivir
Trial completion, Enrollment change: SMV + SOF With/Without RBV for IFN-II Patients With CHC (clinicaltrials.gov) - Jul 7, 2016
P4, N=24, Completed, Sponsor: SC Liver Research Consortium, LLC
Trial primary completion date: Sep 2016 --> Dec 2016 Active, not recruiting --> Completed | N=40 --> 24
- | 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
- |||| Olysio (simeprevir) / J&J, Medivir
Trial completion, Enrollment change: ACCORDION-1: Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of Simeprevir, Daclatasvir and Sofosbuvir in Treatment-naive Participants With Chronic Hepatitis C Virus Genotype 1 Infection (clinicaltrials.gov) - Jun 28, 2016
P2, N=68, Completed, Sponsor: Janssen Research & Development, LLC
Active, not recruiting --> Completed | N=40 --> 24 Recruiting --> Completed | N=90 --> 68
- | Olysio (simeprevir) / J&J, Medivir
Trial completion: A Study to Investigate the Pharmacokinetic Interactions Between Simeprevir and Ledipasvir in a Treatment Regimen Consisting of Simeprevir, Sofosbuvir, and Ledipasvir in Treatment-naive Participants With Chronic Hepatitis C Virus Genotype 1 Infection (clinicaltrials.gov) - May 31, 2016
P2, N=41, Completed, Sponsor: Janssen Sciences Ireland UC
Recruiting --> Completed | N=90 --> 68 Recruiting --> Completed
- Olysio (simeprevir) / J&J, Medivir
Enrollment closed, Enrollment change: Reversal of Hepatic Impairment in Patients With Hepatitis C Virus (HCV) and Early Decompensation of Cirrhosis (clinicaltrials.gov) - May 18, 2016
P3, N=9, Active, not recruiting, Sponsor: University of Colorado, Denver
Recruiting --> Completed Recruiting --> Active, not recruiting | N=25 --> 9
- ||| 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.
Recruiting --> Active, not recruiting | N=25 --> 9 N=60 --> 140
- || Olysio (simeprevir) / J&J, Medivir, Daklinza (daclatasvir) / BMS
New P3 trial: FRI-STC: Impact of Interferon Free Regimens in Patients With Chronic HCV and Successfully Treated HCC (clinicaltrials.gov) - May 13, 2016
P3, N=150, Recruiting, Sponsor: National Hepatology & Tropical Medicine Research Institute
- ||||| 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
- |||| Olysio (simeprevir) / J&J, Medivir
Trial completion: COMMIT: A Study to Assess the Efficacy and Safety of the Combination of Simeprevir and Daclatasvir in Chronic Hepatitis C Genotype 1b-Infected Participants (clinicaltrials.gov) - May 5, 2016
P2, N=106, Completed, Sponsor: Janssen-Cilag International NV
N=60 --> 140 Active, not recruiting --> Completed
- New trial: Impact of Antiviral Therapy on Gastroesophageal Varices. (clinicaltrials.gov) - May 2, 2016
P=N/A, N=374, Active, not recruiting, Sponsor: Parc de Salut Mar
- | Olysio (simeprevir) / J&J, Medivir
New P4 trial: Sofosbuvir/Simeprevir Plus a Flat Dose of Ribavirin in Genotype 1 Elderly HCV Cirrhotic Patients (clinicaltrials.gov) - Mar 9, 2016
P4, N=270, Completed, Sponsor: Azienda Ospedaliera San Camillo Forlanini
- Olysio (simeprevir) / J&J, Medivir
Trial completion, Trial primary completion date: The SIM-SOF Trial for Hepatitis C (clinicaltrials.gov) - Mar 4, 2016
P4, N=82, Completed, Sponsor: Center For Hepatitis C, Atlanta, GA
Active, not recruiting --> Completed Active, not recruiting --> Completed | Trial primary completion date: Aug 2014 --> Dec 2014
- Sunvepra (asunaprevir) / BMS, Olysio (simeprevir) / J&J, Medivir, Daklinza (daclatasvir) / BMS
Trial completion: Triple DAAs Regimen in Treating Non-cirrhotic HCV GT1b Subjects (clinicaltrials.gov) - Mar 1, 2016
P2, N=18, Completed, Sponsor: Humanity & Healthy GI and Liver Centre
Active, not recruiting --> Completed | Trial primary completion date: Aug 2014 --> Dec 2014 Recruiting --> Completed