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12 Products |  |
51 Diseases | | 12 Products |
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10 Trials |  |
1329 News |  |
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- ||| 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
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
- | Adasuve (staccato loxapine) / AOP Orphan Pharma, Teva, Ferrer International, Galen, Medivir
Enrollment open, Head-to-Head: Inhaled Loxapine vs Intramuscular (IM) Haloperidol + Lorazepam for Agitation (clinicaltrials.gov) - Oct 19, 2017
P4, N=140, Recruiting, Sponsor: University of Arkansas
N=250 --> 54 | Trial primary completion date: Dec 2021 --> Oct 2020 Not yet recruiting --> Recruiting
- | Adasuve (staccato loxapine) / AOP Orphan Pharma, Teva, Ferrer International, Galen, Medivir
Phase classification: ADASUVE 2-dose Thorough QT/QTc Study (clinicaltrials.gov) - Oct 18, 2017
P4, N=60, Completed, Sponsor: Alexza Pharmaceuticals, Inc.
Not yet recruiting --> Recruiting Phase classification: P1 --> P4
- ||| 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.
Phase classification: P1 --> P4 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
- | remetinostat (SHP-141) / Medivir
Trial initiation date: Topical Remetinostat in Treating Patient With Cutaneous Basal Cell Cancer (clinicaltrials.gov) - Sep 6, 2017
P2, N=30, Not yet recruiting, Sponsor: Kavita Sarin
Recruiting --> Active, not recruiting Initiation date: Aug 2017 --> Jan 2018
- |||| birinapant (IGM-9427) / IGM Biosciences
Enrollment open, Trial initiation date, Trial primary completion date, Combination therapy: KEYNOTE 163: Dose-escalation Study of Birinapant and Pembrolizumab in Solid Tumors (clinicaltrials.gov) - Aug 30, 2017
P1/2, N=104, Recruiting, Sponsor: Medivir
Initiation date: Aug 2017 --> Jan 2018 Not yet recruiting --> Recruiting | Initiation date: Feb 2017 --> Aug 2017 | Trial primary completion date: Jan 2021 --> Jun 2021
- |||| MIV 710 / Medivir, MIV-711 / Medivir
Trial completion: A Study to Evaluate the Efficacy, Safety and Tolerability of MIV-711 in Osteoarthritis Patients (clinicaltrials.gov) - Aug 25, 2017
P2a, N=244, Completed, Sponsor: Medivir
Not yet recruiting --> Recruiting | Initiation date: Feb 2017 --> Aug 2017 | Trial primary completion date: Jan 2021 --> Jun 2021 Active, not recruiting --> Completed
- | MIV 710 / Medivir, MIV-711 / Medivir
Enrollment closed, Enrollment change: A Study to Evaluate Safety and Tolerability of MIV-711 in Osteoarthritis Patients (clinicaltrials.gov) - Aug 25, 2017
P2, N=50, Active, not recruiting, Sponsor: Medivir
Active, not recruiting --> Completed Recruiting --> Active, not recruiting | N=80 --> 50
- || 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 | N=80 --> 50 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 São Paulo
N=90 --> 120 Active, not recruiting --> Completed
- | birinapant (TL 32711) / Medivir
Journal: SMAC mimetic birinapant plus radiation eradicates human head and neck cancers with genomic amplifications of cell death genes FADD and BIRC2. (Pubmed Central) - Jul 23, 2017
In vivo, birinapant inhibited tumor growth and enhanced radiation induced TNFalpha, tumor responses, and host survival in UM-SCC-46 and -11B xenograft models displaying amplification and overexpression of FADD+/-BIRC2. These findings suggest that combination of SMAC mimetics such as birinapant plus radiation may be particularly active in HNSCC, which harbor frequent FADD/BIRC2 genomic alterations.
- | Adasuve (staccato loxapine) / AOP Orphan Pharma, Teva, Ferrer International, Galen, Medivir
Trial initiation date, Trial primary completion date, Head-to-Head: Inhaled Loxapine vs Intramuscular (IM) Haloperidol + Lorazepam for Agitation (clinicaltrials.gov) - Jul 11, 2017
P4, N=140, Not yet recruiting, Sponsor: University of Arkansas
These findings suggest that combination of SMAC mimetics such as birinapant plus radiation may be particularly active in HNSCC, which harbor frequent FADD/BIRC2 genomic alterations. Initiation date: May 2017 --> Aug 2017 | Trial primary completion date: Apr 2019 --> Aug 2019
- || 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
Initiation date: May 2017 --> Aug 2017 | Trial primary completion date: Apr 2019 --> Aug 2019 Trial primary completion date: May 2017 --> Oct 2017
- | remetinostat (SHP-141) / Medivir
New P2 trial: Topical Remetinostat in Treating Patient With Cutaneous Basal Cell Cancer (clinicaltrials.gov) - Jun 8, 2017
P2, N=30, Not yet recruiting, Sponsor: Kavita Sarin
- ||| 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, 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 --> Completed Not yet recruiting --> Recruiting
- | birinapant (IGM-9427) / IGM Biosciences
Trial termination, Metastases: Birinapant for Advanced Ovarian, Fallopian Tube, and Peritoneal Cancer (clinicaltrials.gov) - Apr 18, 2017
P2, N=11, Terminated, Sponsor: National Cancer Institute (NCI)
Not yet recruiting --> Recruiting Completed --> Terminated; Accrual was terminated for lack of a clinical benefit.
- | Adasuve (staccato loxapine) / AOP Orphan Pharma, Teva, Ferrer International, Galen, Medivir
New P4 trial, Head-to-Head: Inhaled Loxapine vs Intramuscular (IM) Haloperidol + Lorazepam for Agitation (clinicaltrials.gov) - Apr 12, 2017
P4, N=140, Not yet recruiting, Sponsor: University of Arkansas
- |||||||||| 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
- | 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
Completed --> Terminated; Accrual was terminated for lack of a clinical benefit. Trial primary completion date: Jun 2016 --> Jun 2017
- |||| Adasuve (staccato loxapine) / AOP Orphan Pharma, Teva, Ferrer International, Galen, Medivir
Enrollment open, Trial initiation date, Trial primary completion date: Phase IV to Evaluate the Safety of Self-administered ADASUVE (clinicaltrials.gov) - Mar 29, 2017
P4, N=500, Recruiting, Sponsor: Ferrer Internacional S.A.
Trial primary completion date: Jun 2016 --> Jun 2017 Not yet recruiting --> Recruiting | Initiation date: Nov 2015 --> Sep 2016 | Trial primary completion date: Aug 2017 --> Dec 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
Not yet recruiting --> Recruiting | Initiation date: Nov 2015 --> Sep 2016 | Trial primary completion date: Aug 2017 --> Dec 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 São Paulo
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 α -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
- ||| MIV 710 / Medivir, MIV-711 / Medivir
Enrollment closed: A Study to Evaluate the Efficacy, Safety and Tolerability of MIV-711 in Osteoarthritis Patients (clinicaltrials.gov) - Dec 23, 2016
P2a, N=244, Active, not recruiting, Sponsor: Medivir
Recruiting --> Active, not recruiting 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
- | birinapant (IGM-9427) / IGM Biosciences
Trial initiation date, Combination therapy: Birinapant and Carboplatin in Treating Patients With Recurrent High Grade Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (clinicaltrials.gov) - Oct 31, 2016
P2, N=34, Not yet recruiting, Sponsor: Jonsson Comprehensive Cancer Center
Recruiting --> Completed Initiation date: Jul 2016 --> Jan 2017
- | 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
- ||| adafosbuvir (AL-335) / J&J, Medivir
Trial completion, Enrollment change: First in Human Study of AL-335; Single Dose, Food Effect in Healthy Volunteers; Multiple Doses in Chronic Hepatitis C Genotype 1 (clinicaltrials.gov) - Oct 21, 2016
P1, N=112, Completed, Sponsor: Alios Biopharma Inc.
Initiation date: Jul 2016 --> Jan 2017 Recruiting --> Completed | N=70 --> 112