- |||||||||| Copegus (ribavirin) / Bausch Health, Olysio (simeprevir) / J&J, Medivir, Cimivir-L (sofosbuvir+ledipasvir) / Gilead
Journal: No difference between direct-acting antivirals for hepatitis C in hepatocellular carcinoma risk. (Pubmed Central) - Apr 11, 2019 There are no significant differences between DAA regimens in HCC risk after antiviral treatment. This suggests that DAAs do not have direct carcinogenic effects as it would be unlikely that different DAAs would have identical carcinogenic effects.
- |||||||||| Olysio (simeprevir) / J&J, Medivir
Clinical, Journal: VIROLOGICAL PATTERNS OF HCV PATIENTS WITH FAILURE TO INTERFERON-FREE REGIMENS. (Pubmed Central) - Apr 3, 2019 However, excluding those with premature treatment discontinuation for unknown reasons and the lack of FU12, the SVR rates were comparable between the two groups. In our real-life population the prevalence of RASs was high, especially in NS3 and NS5A and in those treated with suitable DAA regimens.
- |||||||||| Pegasys (pegylated interferon α -2a) / Roche, Sunvepra (asunaprevir) / BMS, Olysio (simeprevir) / J&J, Medivir
Trial completion date, Trial primary completion date: SWITCH-1: Switching Regimen in Treating Cirrhotic HCV GT1b Subjects (clinicaltrials.gov) - Feb 28, 2019 P2, N=160, Recruiting, Recruiting --> Completed Trial completion date: Mar 2019 --> Dec 2020 | Trial primary completion date: Dec 2018 --> Oct 2020
- |||||||||| Olysio (simeprevir) / J&J, Medivir
Trial completion date, Trial primary completion date: Comparative Study of Two Regiemns in Management of Sofosbuvir/Daclatasvir Failure (clinicaltrials.gov) - Oct 9, 2018 P=N/A, N=50, Recruiting, Trial completion date: Dec 2018 --> Dec 2019 | Trial primary completion date: Dec 2018 --> Dec 2019 Trial completion date: Sep 2018 --> Jan 2019 | Trial primary completion date: Jun 2018 --> Jan 2019
- |||||||||| Adasuve (staccato loxapine) / AOP Orphan Pharma, Teva, Ferrer International, Galen, Medivir
Trial completion date, Trial primary completion date: Phase IV to Evaluate the Safety of Self-administered ADASUVE (clinicaltrials.gov) - Aug 21, 2018 P4, N=500, Recruiting, Trial completion date: Sep 2018 --> Jan 2019 | Trial primary completion date: Jun 2018 --> Jan 2019 Trial completion date: Mar 2018 --> Dec 2019 | Trial primary completion date: Dec 2017 --> Aug 2019
- |||||||||| birinapant (IGM-9427) / IGM Biosciences
Enrollment change, Trial withdrawal, Combination therapy: Birinapant and Carboplatin in Treating Patients With Recurrent High Grade Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (clinicaltrials.gov) - Aug 16, 2018 P1/2, N=0, Withdrawn, Simeprevir+sofosbuvir treatment, with or without ribavirin, was efficacious and well tolerated (ClinicalTrials. N=17 --> 0 | Not yet recruiting --> Withdrawn
- |||||||||| 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, Active, not recruiting --> Completed | Trial completion date: Dec 2019 --> Apr 2018 Active, not recruiting --> Completed
- |||||||||| Adasuve (staccato loxapine) / AOP Orphan Pharma, Teva, Ferrer International, Galen, Medivir
Enrollment change, Trial completion date, Trial termination, Trial primary completion date, Head-to-Head: Inhaled Loxapine vs Intramuscular (IM) Haloperidol + Lorazepam for Agitation (clinicaltrials.gov) - Apr 6, 2018 P4, N=2, Terminated, This assay is ready for use in clinical trials to elucidate the mechanism of action of investigational agents and combination regimens intended to inflict DNA damage, apoptotic cell death, or both. N=140 --> 2 | Trial completion date: Aug 2019 --> Apr 2018 | Recruiting --> Terminated | Trial primary completion date: Aug 2019 --> Apr 2018; Sponsor Withdrawal
- |||||||||| Pegasys (pegylated interferon α -2a) / Roche, Sunvepra (asunaprevir) / BMS, Olysio (simeprevir) / J&J, Medivir
Trial completion date, Trial primary completion date: SWITCH-1: Switching Regimen in Treating Cirrhotic HCV GT1b Subjects (clinicaltrials.gov) - Mar 19, 2018 P2, N=160, Recruiting, 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: Dec 2017 --> Mar 2019 | Trial primary completion date: Dec 2017 --> Dec 2018
- |||||||||| Sovaldi (sofosbuvir) / Gilead
Trial completion, Enrollment change, Trial completion date, Trial initiation date, Trial primary completion date: Safety and Efficacy of Sofosbuvir-Based Regimens in the Treatment of Egyptian Patients With Hepatitis C Infection (clinicaltrials.gov) - Mar 8, 2018 P4, N=10000, Completed, HER2T798I-mediated neratinib resistance may be overcome by other irreversible HER2 inhibitors like afatinib. Recruiting --> Completed | N=6000 --> 10000 | Trial completion date: Dec 2018 --> Mar 2018 | Initiation date: Dec 2016 --> Jan 2015 | Trial primary completion date: Dec 2018 --> Jan 2018
- |||||||||| 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, Initiation date: Feb 2018 --> Apr 2018 Trial completion date: May 2018 --> May 2018 | Initiation date: Jan 2017 --> Dec 2016 | Trial primary completion date: May 2018 --> May 2018
- |||||||||| remetinostat (SHP-141) / Medivir
Trial initiation date, Trial primary completion date: Topical Remetinostat in Treating Patient With Cutaneous Basal Cell Cancer (clinicaltrials.gov) - Jan 23, 2018 P2, N=30, Not yet recruiting, Trial completion date: May 2018 --> May 2018 | Initiation date: Jan 2017 --> Dec 2016 | Trial primary completion date: May 2018 --> May 2018 Initiation date: Jan 2018 --> Jul 2018 | Trial primary completion date: Dec 2018 --> Jun 2019
- |||||||||| 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, Active, not recruiting --> Completed 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.
- |||||||||| adafosbuvir (AL-335) / J&J, Medivir
Trial completion, Enrollment change, Trial primary completion date: A Study to Evaluate the Effect of Renal Impairment on the Pharmacokinetics of AL-335 (clinicaltrials.gov) - Dec 20, 2017 P1, N=24, Completed, 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. Recruiting --> Completed | N=32 --> 24 | Trial primary completion date: Mar 2017 --> Aug 2017
- |||||||||| Adasuve (staccato loxapine) / AOP Orphan Pharma, Teva, Ferrer International, Galen, Medivir
Phase classification: ADASUVE-Lorazepam Drug-Drug Interaction (clinicaltrials.gov) - Dec 13, 2017 P4, N=22, Completed, Recruiting --> Completed | N=32 --> 24 | Trial primary completion date: Mar 2017 --> Aug 2017 Phase classification: P1 --> P4
- |||||||||| 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, Active, not recruiting --> Completed Trial primary completion date: Oct 2017 --> May 2018
- |||||||||| birinapant (IGM-9427) / IGM Biosciences
Phase classification, Enrollment change, Trial initiation date, Trial primary completion date, Combination therapy: Birinapant and Carboplatin in Treating Patients With Recurrent High Grade Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (clinicaltrials.gov) - Nov 20, 2017 P1/2, N=17, Not yet recruiting, Trial primary completion date: Oct 2017 --> May 2018 Phase classification: P2 --> P1/2 | N=34 --> 17 | Initiation date: Jan 2017 --> Dec 2017 | Trial primary completion date: Jul 2019 --> Nov 2019
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