 |
36 Diseases |  |
5 Trials |
|
5 Trials |  |
637 News |  |
| «12345678910» |
- | Technivie (ombitasvir/paritaprevir/ritonavir) / AbbVie
Journal: HCV compliance and treatment success rates are higher with DAAs in structured HCV clinics compared to general hepatology clinics. (Pubmed Central) - Jul 23, 2019
Female patients (P = .02), older age (P < .0001), previous treatment (P = .03), treatment in SHC (OR 1.7, 95% CI 1.2, 2.3, P = .0008), and sofosbuvir/ledipasvir compared to sofosbuvir/velpatasvir, sofosbuvir, or elbasvir/grazoprevir had higher odds of treatment success. With 1:1 matching, the SHC group still had significantly higher odds than the GHC group of achieving treatment and compliance success.Our study shows that the effectiveness of HCV treatment could be improved by coordinating treatment in a structured HCV clinic.
- | Sovaldi (sofosbuvir) / Gilead
Review, Journal, HEOR: Cost-utility analysis of second-generation direct-acting antivirals for hepatitis C: a systematic review. (Pubmed Central) - Jul 17, 2019
Expert commentary: Selected studies may be overestimating the true cost per QALY of second-generation DAAs in the treatment of HCV, mainly because of neglecting non-healthcare costs, using official list prices which are higher than actual transaction prices and not adopting the long run drug price in a dynamic approach. In addition, the impact of important price reductions of several DAAs in recent years on cost per QALY should be considered.
- | Olysio (simeprevir) / J&J, Medivir
Clinical, PK/PD data, Journal: Clinical impact of pharmacokinetic interactions between the HCV protease inhibitor Simeprevir and frequently used concomitant medications. (Pubmed Central) - Jun 26, 2019
In this large pooled analysis, co-administration of the evaluated commonly prescribed medications with known or potential PK interactions with SMV was manageable and resulted in few adjustments of concomitant medications. Our method could serve as a blueprint for the evaluation of the impact of DDIs.
- | glibenclamide / generics
Journal: Functional characterization for polymorphic organic anion transporting polypeptides (OATP/SLCO1B1, 1B3, 2B1) of monkeys recombinantly expressed with various OATP probes. (Pubmed Central) - Jun 17, 2019
...In this study, hepatic uptake by recombinantly expressed monkey OATP1B1, OATP1B3 and OATP2B1 was investigated using three human OATP1B1 and OATP1B3 substrates (pitavastatin, pravastatin and rosuvastatin) and one OATP1B3 substrate (telmisartan), as the governmental drug interaction guidelines recommend, and seven reported clinical drugs...In contrast, atorvastatin, bosentan, etoposide, fexofenadine, fluvastatin, glibenclamide and simeprevir were broadly transported by recombinant monkey OATP1B1, OATP1B3 and OATP2B1...Despite that the sequences of monkey recombinant OATPs are not totally reflexive of those of human OATPs, our results collectively suggested that OATP1B1, OATP1B3 or OATP2B1 in monkeys could mediate roughly similar hepatic uptake of various OATP probes. Recombinant monkey OATPs would be good experimental tools for in vitro hepatic uptake in cell systems.
- | Olysio (simeprevir) / J&J, Medivir, Daklinza (daclatasvir) / BMS
Retrospective data, Journal: A liquid chromatography-tandem mass spectrometry method for simultaneous determination of simeprevir, daclatasvir, sofosbuvir, and GS-331007 applied to a retrospective clinical pharmacological study. (Pubmed Central) - Jun 14, 2019
Importantly, patients with high plasma levels of GS-331007 also showed enhanced concentration of DCV and SMV probably due to a specific metabolic/pathological condition. Altogether, our findings indicate that the proposed method is a reliable and accurate new tool for high-throughput screening of large patient cohorts that could be readily used to optimize treatment modalities and reduce drug-related toxicities.
- | paritaprevir/ritonavir (ABT-450/r) / AbbVie, Daklinza (daclatasvir) / BMS
Clinical, Retrospective data, Journal, Adverse events: The adverse effects of interferon-free regimens in 149 816 chronic hepatitis C treated Egyptian patients. (Pubmed Central) - Jun 4, 2019
Adverse effects associated with DAAs are few, anaemia being the most common. SOF/RBV regimen showed the highest rate of side effects while SOF/DCV showed the least.
- | Sovaldi (sofosbuvir) / Gilead
Clinical, Journal: The Observed Effect of Gastric Bypass Surgery on Direct-acting Antiviral Treatment: a Case Report. (Pubmed Central) - May 22, 2019
Sofosbuvir, GS-331007, and ribavirin exposure were comparable with levels described in literature. The patient achieved a sustained virological response twelve weeks after the completion of treatment.
- | Olysio (simeprevir) / J&J, Medivir
Clinical, Journal: Safety and efficacy of the combination simeprevir-sofosbuvir in HCV genotype 1- and 4-mono-infected patients from the French ANRS CO22 hepather cohort. (Pubmed Central) - May 15, 2019
P=N/A
The patient achieved a sustained virological response twelve weeks after the completion of treatment. In this real life, observational, prospective cohort study, the 12-week sofosbuvir/simeprevir+/-ribavirin combination appears to be efficient and safe.
- | Technivie (ombitasvir/paritaprevir/ritonavir) / AbbVie, Daklinza (daclatasvir) / BMS
Clinical, Observational data, Journal: Hepatitis C treatment with all-oral direct-acting antivirals: Effectiveness and tolerance in a multicenter, prospective, observational study from French general hospitals (APROVVIE, ANGH). (Pubmed Central) - May 6, 2019
Second generation DAAs combinations are as effective and well tolerated in a « real-world » population as in clinical trials. Further studies are needed on renal tolerance.
- | Daklinza (daclatasvir) / BMS
Clinical, Journal, HEOR: Cost-effectiveness analysis of Daclatasvir/Sofosbuvir for the treatment of the HCV patients failed after the first line with second generation of DAAs in Italy. (Pubmed Central) - May 5, 2019
In the base-case analysis, DCV+SOF represents a cost-effectiveness therapy with ICERs lower than the threshold. The PSA showed robust results, ICERs remain below threshold in 94% and 99% simulations in Scenario 1 and 2, respectively.
- | Sunvepra (asunaprevir) / BMS, paritaprevir/ritonavir (ABT-450/r) / AbbVie, Daklinza (daclatasvir) / BMS
Retrospective data, Review, Journal: Direct-acting antiviral agents for liver transplant recipients with recurrent genotype 1 hepatitis C virus infection: systematic review and meta-analysis. (Pubmed Central) - May 5, 2019
The PSA showed robust results, ICERs remain below threshold in 94% and 99% simulations in Scenario 1 and 2, respectively. Direct-acting antiviral treatment is highly effective and well-tolerated in liver transplant recipients with recurrent GT1 HCV infection.
- | Olysio (simeprevir) / J&J, Medivir, Cimivir-L (sofosbuvir+ledipasvir) / Gilead
Clinical, Journal: Multicenter Experience using Ledipasvir/Sofosbuvir ± RBV to Treat HCV GT 1 Relapsers after Simeprevir and Sofosbuvir Treatment. (Pubmed Central) - Apr 24, 2019
Direct-acting antiviral treatment is highly effective and well-tolerated in liver transplant recipients with recurrent GT1 HCV infection. Treatment with LDV/SOF with/without RBV for 12-24 weeks was very well tolerated and resulted in high SVR 12 rates (96%) in HCV GT1 relapsers to SMV + SOF treatment.
- | Olysio (simeprevir) / J&J, Medivir
Clinical, Journal: Interferon-based Simeprevir Therapy for Pediatric Patients with Chronic Hepatitis C Viral Infection. (Pubmed Central) - Apr 24, 2019
Interferon-based simeprevir therapy showed high efficacy and tolerability in children with genotype 1 hepatitis C virus infection. While direct-acting antivirals (DAAs) therapy are undergoing study in children, this regimen is considered an available therapeutic option for selected patients in countries where DAAs have not yet been approved.
- | Olysio (simeprevir) / J&J, Medivir, Sovaldi (sofosbuvir) / Gilead
Clinical, Journal: Influence of baseline MELD score in the efficacy of treatment of hepatitis C with simeprevir and sofosbuvir. (Pubmed Central) - Apr 19, 2019
It is a safe therapy, especially in patients without ribavirin. This combination was more effective in patients with a MELD score below 10.
- | Olysio (simeprevir) / J&J, Medivir, Cimivir-L (sofosbuvir+ledipasvir) / Gilead
Clinical, Journal: Personalized treatment of hepatitis C genotype 1a in Norway and Sweden 2014-2016: a study of treatment outcome in patients with or without resistance-based DAA-therapy. (Pubmed Central) - Apr 18, 2019
This combination was more effective in patients with a MELD score below 10. In line with the findings of the OPTIMIST-2 trial for Q80K and the EASL-guidelines 2016 for NS5A-RASs, baseline RASs appeared to have an impact on treatment outcome albeit a statistical significance was not observed in this low-prevalence population.
- | Technivie (ombitasvir/paritaprevir/ritonavir) / AbbVie, paritaprevir/ritonavir (ABT-450/r) / AbbVie
Journal: Insulin resistance does not impair response of chronic hepatitis C virus to direct-acting antivirals, and improves with the treatment. (Pubmed Central) - Apr 11, 2019
In line with the findings of the OPTIMIST-2 trial for Q80K and the EASL-guidelines 2016 for NS5A-RASs, baseline RASs appeared to have an impact on treatment outcome albeit a statistical significance was not observed in this low-prevalence population. IR does not impair the response of patients with HCV treated with DAAs, and improves significantly in patients who achieve an SVR.
- | 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.
- | Copegus (ribavirin) / Bausch Health, Daklinza (daclatasvir) / BMS
Journal: Long-term follow-up of ribavirin-free DAA-based treatment in HCV-recurrence after orthotopic liver transplantation. (Pubmed Central) - Apr 10, 2019
RBV-free DAA-combinations for the treatment of HCV-recurrence after OLT are highly efficacious and well tolerated. Our long-term data show that viral eradication is durable but not necessarily translated into beneficial long-term clinical outcome.
- | Copegus (ribavirin) / Bausch Health, Olysio (simeprevir) / J&J, Medivir
Clinical, Journal: Efficacy and safety of sofosbuvir-based regimens for treatment in chronic hepatitis C genotype 1 patients with moderately impaired renal function. (Pubmed Central) - Apr 5, 2019
SOF-based regimens resulted in high SVR12 rates in patients with moderately impaired renal function. During therapy, HCV patients with CKD should be carefully monitored for worsening renal function.
- paritaprevir/ritonavir (ABT-450/r) / AbbVie
The comparison of hepatitis C treatment outcomes with direct acting antivirals between people who inject drugs (PWID) and non-PWID: results from a national survey in Slovenia () - Apr 5, 2019 - Abstract #ECCMID2019ECCMID_1144;
Our results confirm excellent SVR rates of DAAs in real-life setting with better results achieved in non-PWID compared to PWID. However, excluding those with premature treatment discontinuation for unknown reasons and the lack of FU12, the SVR rates were comparable between the two groups.
- | 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.
- | Technivie (ombitasvir/paritaprevir/ritonavir) / AbbVie, Daklinza (daclatasvir) / BMS
Clinical, Journal: Efficacy of Direct-acting Antivirals to Improve Clinical Condition, Fibrosis, and Liver Function in Liver Transplant Recipients Infected by Hepatitis C. (Pubmed Central) - Mar 27, 2019
In our real-life population the prevalence of RASs was high, especially in NS3 and NS5A and in those treated with suitable DAA regimens. DAAs were used successfully in the treatment of hepatitis C after orthotopic liver transplantation and resulted in significant improvement in liver function as measured by MELD score, fibrosis level, and cirrhotic clinical condition, even in patients with very advanced disease.
- | 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.
- | Olysio (simeprevir) / J&J, Medivir
Trial completion: Comparative Study of Two Regiemns in Management of Sofosbuvir/Daclatasvir Failure (clinicaltrials.gov) - Mar 19, 2019
P=N/A, N=40, Completed, Sponsor: Assiut University
However, inadequate efficacy was observed for the 2-DAA regimen in GT1-infected subjects and the 3-DAA regimen in GT3-infected subjects. Recruiting --> Completed
- | 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, Sponsor: Humanity and Health Research Centre
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: Reversal of Hepatic Impairment in Patients With Hepatitis C Virus (HCV) and Early Decompensation of Cirrhosis (clinicaltrials.gov) - Jan 17, 2019
P3, N=9, Active, not recruiting, Sponsor: University of Colorado, Denver
Trial completion date: Mar 2019 --> Dec 2020 | Trial primary completion date: Dec 2018 --> Oct 2020 Trial completion date: Dec 2018 --> Dec 2019 | Trial primary completion date: Dec 2018 --> Dec 2019
- | 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, Sponsor: Assiut University
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
- | Olysio (simeprevir) / J&J, Medivir
Clinical, Journal: Efficacy and Safety of Simeprevir and Sofosbuvir With and Without Ribavirin in Subjects With Recurrent Genotype 1 Hepatitis C Post-Orthotopic Liver Transplant: The Randomized GALAXY Study. (Pubmed Central) - Aug 17, 2018
P2
Simeprevir exposure was increased relative to the non-transplant setting, but not considered clinically relevant. Simeprevir+sofosbuvir treatment, with or without ribavirin, was efficacious and well tolerated (ClinicalTrials.
- | 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.
Simeprevir+sofosbuvir treatment, with or without ribavirin, was efficacious and well tolerated (ClinicalTrials. Active, not recruiting --> Completed | N=320 --> 161
- | Olysio (simeprevir) / J&J, Medivir
Trial completion, Trial completion date: An Efficacy, Safety and Pharmacokinetics Study of Simeprevir, Daclatasvir and Sofosbuvir in Participants With Chronic Hepatitis C Virus Genotype 1 or 4 Infection and Decompensated Liver Disease (clinicaltrials.gov) - Jul 12, 2018
P2, N=40, Completed, Sponsor: Janssen Research & Development, LLC
Active, not recruiting --> Completed | N=320 --> 161 Active, not recruiting --> Completed | Trial completion date: Dec 2019 --> Apr 2018
- || 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 | Trial completion date: Dec 2019 --> Apr 2018 Active, not recruiting --> Completed
- | Olysio (simeprevir) / J&J, Medivir
New trial: Comparative Study of Two Regiemns in Management of Sofosbuvir/Daclatasvir Failure (clinicaltrials.gov) - Jun 7, 2018
P=N/A, N=50, Recruiting, Sponsor: Assiut University
- | Trial completion, Enrollment change: Impact of Antiviral Therapy on Gastroesophageal Varices. (clinicaltrials.gov) - May 30, 2018
P=N/A, N=237, Completed, Sponsor: Parc de Salut Mar
Active, not recruiting --> Completed Active, not recruiting --> Completed | N=374 --> 237
- Olysio (simeprevir) / J&J, Medivir
Trial completion date: An Efficacy, Safety and Pharmacokinetics Study of Simeprevir, Daclatasvir and Sofosbuvir in Participants With Chronic Hepatitis C Virus Genotype 1 or 4 Infection and Decompensated Liver Disease (clinicaltrials.gov) - Apr 25, 2018
P2, N=40, Active, not recruiting, Sponsor: Janssen Research & Development, LLC
Active, not recruiting --> Completed | N=374 --> 237 Trial completion date: Mar 2020 --> Dec 2019
- 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
Trial completion date: Mar 2020 --> Dec 2019 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
- | Pegasys (pegylated interferon ? -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, Sponsor: Humanity and Health Research Centre
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, Sponsor: Tanta University
Trial completion date: Dec 2017 --> Mar 2019 | Trial primary completion date: Dec 2017 --> Dec 2018 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, Sponsor: Janssen Pharmaceutical K.K.
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: May 2018 --> May 2018 | Initiation date: Jan 2017 --> Dec 2016 | Trial primary completion date: May 2018 --> May 2018
- 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) - Jan 17, 2018
P3, N=9, Active, not recruiting, Sponsor: University of Colorado, Denver
Trial completion date: May 2018 --> May 2018 | Initiation date: Jan 2017 --> Dec 2016 | Trial primary completion date: May 2018 --> May 2018 Trial primary completion date: Dec 2017 --> Dec 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 primary completion date: Dec 2017 --> Dec 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
- | Sovaldi (sofosbuvir) / Gilead
Enrollment change: Safety and Efficacy of Sofosbuvir-Based Regimens in the Treatment of Egyptian Patients With Hepatitis C Infection (clinicaltrials.gov) - Nov 14, 2017
P4, N=6000, Recruiting, Sponsor: Tanta University
Trial primary completion date: Oct 2017 --> May 2018 N=1000 --> 6000
- ||| 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
N=1000 --> 6000 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
- ||||| 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