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18 Diseases |  |
22 Trials |
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22 Trials |  |
2501 News |  |
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- | Mavyret (glecaprevir/pibrentasvir) / AbbVie, Enanta Pharma
Clinical Trial,Phase I, Clinical Trial,Phase II, Clinical Trial,Phase III, Journal: Glecaprevir-Pibrentasvir for 8 or 12 Weeks in HCV Genotype 1 or 3 Infection. (Pubmed Central) - Feb 11, 2018
P3
Conclusions Once-daily treatment with glecaprevir-pibrentasvir for either 8 weeks or 12 weeks achieved high rates of sustained virologic response among patients with HCV genotype 1 or 3 infection who did not have cirrhosis. (Funded by AbbVie; ENDURANCE-1 and ENDURANCE-3 ClinicalTrials.gov numbers, NCT02604017 and NCT02640157 .).
- | Sovaldi (sofosbuvir) / Gilead
Journal: Sofosbuvir-based regimens for the treatment of chronic hepatitis C in severe renal dysfunction. (Pubmed Central) - Feb 9, 2018
To confirm these retrospective findings, prospective studies that include SOF and SOF metabolite measurements coupled with prospective serial monitoring of electrocardiograms and echocardiograms are needed. (Hepatology Communications 2017;1:248-255).
- || Vosevi (sofosbuvir/velpatasvir/voxilaprevir) / Gilead, Sovaldi (sofosbuvir) / Gilead
Trial completion date, Trial primary completion date: A Registry for Adolescent and Pediatric Participants Who Received a Gilead Hepatitis C Virus Direct Acting Antiviral (DAA) in Gilead-Sponsored Chronic Hepatitis C Infection Trials (clinicaltrials.gov) - Feb 5, 2018
P=N/A, N=500, Enrolling by invitation, Sponsor: Gilead Sciences
(Hepatology Communications 2017;1:248-255). Trial primary completion date: Apr 2023 --> Sep 2027 | Trial completion date: Apr 2023 --> Sep 2027
- Sovaldi (sofosbuvir) / Gilead
Enrollment closed, Enrollment change: Sovaldi-based Regimens in Patients in Mexico With Chronic Hepatitis C Virus Infection in Clinical Practice (clinicaltrials.gov) - Feb 5, 2018
P=N/A, N=25, Active, not recruiting, Sponsor: Gilead Sciences
Trial primary completion date: Apr 2023 --> Sep 2027 | Trial completion date: Apr 2023 --> Sep 2027 Recruiting --> Active, not recruiting | N=300 --> 25
- | coblopasvir (KW 136) / Beijing Kawin
New P2 trial: Safety and Efficacy of KW-136 and Sofosbuvir for Treatment of Chronic Hepatitis C (clinicaltrials.gov) - Jan 31, 2018
P2, N=110, Completed, Sponsor: Kawin Technology Share-holding Co., Ltd.
- || Sovaldi (sofosbuvir) / Gilead
Trial primary completion date: Sovaldi-based Regimens in Patients in Mexico With Chronic Hepatitis C Virus Infection in Clinical Practice (clinicaltrials.gov) - Dec 14, 2017
P=N/A, N=300, Recruiting, Sponsor: Gilead Sciences
Recruiting --> Active, not recruiting | N=300 --> 25 Trial primary completion date: Jan 2019 --> Jun 2018
- Sovaldi (sofosbuvir) / Gilead
Enrollment open, Trial primary completion date: HepNet Pilot Trial: Multicenter Trial for the Treatment of Chronic Hepatitis E With Sofosbuvir (SofE) (clinicaltrials.gov) - Dec 6, 2017
P2, N=10, Recruiting, Sponsor: Hannover Medical School
Trial primary completion date: Jan 2019 --> Jun 2018 Not yet recruiting --> Recruiting | Trial primary completion date: Sep 2018 --> Dec 2018
- | Sovaldi (sofosbuvir) / Gilead, ledipasvir/sofosbuvir / Generic mfg.
Journal: Safety and Efficacy of Sofosbuvir-Containing Regimens in Hepatitis C Infected Patients with Impaired Renal Function. (Pubmed Central) - Dec 1, 2017
However, these patients had higher rates of anaemia, worsening renal dysfunction and serious adverse events regardless of use of RBV. Patient with renal impairment require close monitoring and should be treated by providers extensively experienced with SOF-containing regimens.
- | velpatasvir (GS-5816) / Gilead
Journal: Intra-hepatic Depletion of Mucosal Associated Invariant T cells in Hepatitis C Virus-induced Liver Inflammation. (Pubmed Central) - Nov 30, 2017
Patient with renal impairment require close monitoring and should be treated by providers extensively experienced with SOF-containing regimens. In analyses of paired blood and liver samples from patients with chronic HCV infection before, during, and after antiviral therapy with sofosbuvir and velpatasvir, we found that intrahepatic MAIT cells are activated by monocyte-derived cytokines and depleted in HCV-induced liver inflammation.
- | 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
In analyses of paired blood and liver samples from patients with chronic HCV infection before, during, and after antiviral therapy with sofosbuvir and velpatasvir, we found that intrahepatic MAIT cells are activated by monocyte-derived cytokines and depleted in HCV-induced liver inflammation. N=1000 --> 6000
- | Sovaldi (sofosbuvir) / Gilead, ledipasvir/sofosbuvir / Generic mfg.
Journal: Disparate access to treatment regimens in chronic hepatitis C patients: data from the TRIO network. (Pubmed Central) - Nov 3, 2017
We evaluated patients in the TRIO network who were prescribed sofosbuvir (SOF)-based regimens to determine reasons for not starting treatment...In fact, almost half of the nonstart patients had advanced fibrosis scores (F3 or F4) and should have been prioritized to start treatment. As better treatment for HCV with high efficacy and low side effect rates become available, the disparity in access to treatment, as evidenced by the high nonstart rate in the Medicaid-covered group, must be resolved.
- | ribavirin / Generic mfg., Sovaldi (sofosbuvir) / Gilead
Retrospective data, Journal: Simeprevir and sofosbuvir with or without ribavirin to treat recurrent genotype 1 hepatitis C virus infection after orthotopic liver transplantation. (Pubmed Central) - Oct 28, 2017
However, 12 weeks may not be the optimal duration of therapy for those with detectable virus at week 4 or possibly for those with cirrhosis. These data require confirmation by prospective randomized clinical trials.
- | Daklinza (daclatasvir) / BMS, Sovaldi (sofosbuvir) / Gilead
Journal: On-Treatment HCV RNA as a Predictor of Sustained Virologic Response in HCV Genotype 3-Infected Patients Treated With Daclatasvir and Sofosbuvir. (Pubmed Central) - Oct 22, 2017
These data require confirmation by prospective randomized clinical trials. On-treatment responses are not useful predictors of ultimate virological response to the daclatasvir + sofosbuvir regimen.
- | pibrentasvir (ABT-530) / AbbVie, glecaprevir (ABT-493) / AbbVie, Mavyret (glecaprevir/pibrentasvir) / AbbVie, Enanta Pharma
Clinical Trial,Phase I, Clinical Trial,Phase II, Clinical Trial,Phase III, Journal: Glecaprevir and Pibrentasvir in Patients with HCV and Severe Renal Impairment. (Pubmed Central) - Oct 21, 2017
P3
Conclusions Treatment with glecaprevir and pibrentasvir for 12 weeks resulted in a high rate of sustained virologic response in patients with stage 4 or 5 chronic kidney disease and HCV infection. (Funded by AbbVie; ClinicalTrials.gov number, NCT02651194 .).
- | Zepatier (grazoprevir/elbasvir) / Merck (MSD), Sovaldi (sofosbuvir) / Gilead
Trial initiation date, Trial primary completion date: Direct-acting Antiviral Therapy to Prevent HCV Infection for HCV Positive Donor to HCV Negative Recipient Kidney Transplant (clinicaltrials.gov) - Oct 5, 2017
P4, N=30, Not yet recruiting, Sponsor: Massachusetts General Hospital
(Funded by AbbVie; ClinicalTrials.gov number, NCT02651194 .). Initiation date: Sep 2017 --> Feb 2018 | Trial primary completion date: Dec 2019 --> Dec 2020
- Sovaldi (sofosbuvir) / Gilead
New P2 trial: HepNet Pilot Trial: Multicenter Trial for the Treatment of Chronic Hepatitis E With Sofosbuvir (SofE) (clinicaltrials.gov) - Sep 14, 2017
P2, N=10, Not yet recruiting, Sponsor: Hannover Medical School
- || Sovaldi (sofosbuvir) / Gilead
Enrollment closed: Safety and Efficacy of Sofosbuvir-based Regimens in Clinical Practice for the Treatment of Chronic Hepatitis C Virus Infection in India (clinicaltrials.gov) - Aug 28, 2017
P=N/A, N=532, Active, not recruiting, Sponsor: Gilead Sciences
Initiation date: Sep 2017 --> Feb 2018 | Trial primary completion date: Dec 2019 --> Dec 2020 Recruiting --> Active, not recruiting
- ||||| Zepatier (grazoprevir/elbasvir) / Merck (MSD), Sovaldi (sofosbuvir) / Gilead
New P2 trial: A Direct obserVed therApy vs fortNightly CollEction Study for HCV Treatment - ADVANCE HCV Study (clinicaltrials.gov) - Aug 1, 2017
P2, N=135, Not yet recruiting, Sponsor: University of Dundee
- | Mavyret (glecaprevir/pibrentasvir) / AbbVie, Enanta Pharma
Trial primary completion date, Combination therapy: MAGELLAN-3: Efficacy and Safety of Glecaprevir (ABT-493)/Pibrentasvir (ABT 530) (GLE/PIB) in Combination With Sofosbuvir and Ribavirin in Participants With Hepatitis C Virus Who Did Not Respond to Treatment in a Previous AbbVie Clinical Study (clinicaltrials.gov) - Jul 18, 2017
P3, N=40, Enrolling by invitation, Sponsor: AbbVie
Recruiting --> Active, not recruiting Trial primary completion date: Jan 2018 --> Jun 2019
- | Daklinza (daclatasvir) / BMS, Sovaldi (sofosbuvir) / Gilead
New trial: hepatitisc: Hepatitis c and Vitamin D and Iron Status (clinicaltrials.gov) - May 25, 2017
P=N/A, N=87, Not yet recruiting, Sponsor: Eman Sayed Hassan Abd Allah
- || Vosevi (sofosbuvir/velpatasvir/voxilaprevir) / Gilead
Trial primary completion date: A Registry for Participants With Cirrhosis Who Achieve a Sustained Virologic Response Following Treatment With a Sofosbuvir-Based Regimen Without Interferon for Chronic Hepatitis C Infection (clinicaltrials.gov) - May 19, 2017
P=N/A, N=1637, Enrolling by invitation, Sponsor: Gilead Sciences
Trial primary completion date: Jan 2018 --> Jun 2019 Trial primary completion date: Nov 2022 --> May 2024
- |||||| Mavyret (glecaprevir/pibrentasvir) / AbbVie, Enanta Pharma, Sovaldi (sofosbuvir) / Gilead
Enrollment open: Multi-Center, Randomized, Open-Label Study of G/P +/- RBV for NS5A + SOF Previously Treated GT1 HCV Subjects (clinicaltrials.gov) - Apr 26, 2017
P3b, N=225, Recruiting, Sponsor: University of Florida
Trial primary completion date: Nov 2022 --> May 2024 Not yet recruiting --> Recruiting
- | Zepatier (grazoprevir/elbasvir) / Merck (MSD), Sovaldi (sofosbuvir) / Gilead
New P4 trial: Direct-acting Antiviral Therapy to Prevent HCV Infection for HCV Positive Donor to HCV Negative Recipient Kidney Transplant (clinicaltrials.gov) - Mar 28, 2017
P4, N=30, Not yet recruiting, Sponsor: Massachusetts General Hospital
- |||||||||| Mavyret (glecaprevir/pibrentasvir) / AbbVie, Enanta Pharma, Sovaldi (sofosbuvir) / Gilead
New P3 trial: Multi-Center, Randomized, Open-Label Study of G/P +/- RBV for NS5A + SOF Previously Treated GT1 HCV Subjects (clinicaltrials.gov) - Mar 27, 2017
P3b, N=225, Not yet recruiting, Sponsor: University of Florida
- | ribavirin / Generic mfg., Sovaldi (sofosbuvir) / Gilead
Journal: Superiority of Interferon-Free Regimens for Chronic Hepatitis C: The Effect on Health-Related Quality of Life and Work Productivity. (Pubmed Central) - Mar 17, 2017
By contrast, the impact of RBV on these PROs is relatively modest. Achieving HCV cure is associated with improvement of most of the PRO scores.
- | Sovaldi (sofosbuvir) / Gilead
Enrollment change: LONGHEAD: Long-term Outcomes of Chronic Hepatitis C Patients Post Sofosbuvir-based Treatment (clinicaltrials.gov) - Mar 4, 2017
P=N/A, N=200, Recruiting, Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Achieving HCV cure is associated with improvement of most of the PRO scores. N=600 --> 200
- | Sovaldi (sofosbuvir) / Gilead
New trial: LONGHEAD: Long-term Outcomes of Chronic Hepatitis C Patients Post Sofosbuvir-based Treatment (clinicaltrials.gov) - Mar 3, 2017
P=N/A, N=200, Recruiting, Sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
- | Sovaldi (sofosbuvir) / Gilead
New P1 trial: A Bio-equivalence Study of Sofosbuvir From Sofodelevier 400 mg Film Coated Tablets (Al-debeiky Pharma, Egypt) Versus Sovaldi 400 mg Tablets (Gilead Sciences, Canada) (clinicaltrials.gov) - Feb 23, 2017
P1, N=36, Completed, Sponsor: Genuine Research Center, Egypt
- | 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
- || Sovaldi (sofosbuvir) / Gilead
Trial primary completion date: Sovaldi-based Regimens in Patients in Mexico With Chronic Hepatitis C Virus Infection in Clinical Practice (clinicaltrials.gov) - Dec 7, 2016
P=N/A, N=300, Recruiting, Sponsor: Gilead Sciences
N=600 --> 200 Trial primary completion date: Oct 2018 --> Mar 2019
- | Sovaldi (sofosbuvir) / Gilead
New P1 trial: A Bio-equivalence Study of Sofosbuvir From Magicbuvir 400 mg Film Coated Tablets ( Magic Pharma, Egypt) Versus Sovaldi 400 mg Tablets (Gilead Sciences, Canada) (clinicaltrials.gov) - Nov 2, 2016
P1, N=36, Completed, Sponsor: Genuine Research Center, Egypt
- ||| Mavyret (glecaprevir/pibrentasvir) / AbbVie, Enanta Pharma
New P3 trial, Combination therapy: MAGELLAN-3: Efficacy and Safety of Glecaprevir (ABT-493)/Pibrentasvir (ABT 530) (GLE/PIB) in Combination With Sofosbuvir and Ribavirin in Participants With Hepatitis C Virus Who Did Not Respond to Treatment in a Previous AbbVie Clinical Study (clinicaltrials.gov) - Oct 19, 2016
P3, N=40, Enrolling by invitation, Sponsor: AbbVie
- ||| Sovaldi (sofosbuvir) / Gilead
Enrollment open, Real-world evidence: Evaluate the Safety and Effectiveness of Sovaldi in Participants With Chronic Hepatitis C Virus (HCV) Infection in Korea (clinicaltrials.gov) - Oct 19, 2016
P=N/A, N=3000, Recruiting, Sponsor: Gilead Sciences
Trial primary completion date: Oct 2018 --> Mar 2019 Not yet recruiting --> Recruiting
- ||| Sovaldi (sofosbuvir) / Gilead
New trial, Real-world evidence: Evaluate the Safety and Effectiveness of Sovaldi in Participants With Chronic Hepatitis C Virus (HCV) Infection in Korea (clinicaltrials.gov) - Sep 19, 2016
P=N/A, N=3000, Not yet recruiting, Sponsor: Gilead Sciences
- ||| Sovaldi (sofosbuvir) / Gilead
Enrollment open: Sovaldi-based Regimens in Patients in Mexico With Chronic Hepatitis C Virus Infection in Clinical Practice (clinicaltrials.gov) - Jul 15, 2016
P=N/A, N=300, Recruiting, Sponsor: Gilead Sciences
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- || Vosevi (sofosbuvir/velpatasvir/voxilaprevir) / Gilead
Trial primary completion date: A Registry for Participants With Cirrhosis Who Achieve a Sustained Virologic Response Following Treatment With a Sofosbuvir-Based Regimen Without Interferon for Chronic Hepatitis C Infection (clinicaltrials.gov) - Jun 29, 2016
P=N/A, N=2000, Enrolling by invitation, Sponsor: Gilead Sciences
Not yet recruiting --> Recruiting Trial primary completion date: Mar 2021 --> Nov 2022
- ||| Sovaldi (sofosbuvir) / Gilead
New trial: Sovaldi-based Regimens in Patients in Mexico With Chronic Hepatitis C Virus Infection in Clinical Practice (clinicaltrials.gov) - May 26, 2016
P=N/A, N=300, Not yet recruiting, Sponsor: Gilead Sciences
- ||||||| Zepatier (grazoprevir/elbasvir) / Merck (MSD)
Trial completion: Efficacy and Safety of Combination Grazoprevir (MK-5172)/Elbasvir (MK-8742) Versus Sofosbuvir + Pegylated Interferon + Ribavirin in Hepatitis C Virus Genotype 1, 4 or 6 Infection (MK-5172-077) (clinicaltrials.gov) - Feb 26, 2016
P3, N=257, Completed, Sponsor: Merck Sharp & Dohme Corp.
Trial primary completion date: Mar 2021 --> Nov 2022 Active, not recruiting --> Completed
- |||| Zepatier (grazoprevir/elbasvir) / Merck (MSD)
Trial completion: Efficacy and Safety of Grazoprevir (MK-5172), Elbasvir (MK-8742), and Sofosbuvir for Chronic Infection With Hepatitis C Virus Genotypes 1 and 3 (MK-5172-074) (clinicaltrials.gov) - Feb 10, 2016
P2, N=143, Completed, Sponsor: Merck Sharp & Dohme Corp.
Active, not recruiting --> Completed Active, not recruiting --> Completed
- ||| Sovaldi (sofosbuvir) / Gilead
Trial completion: Collection of Plasma and Serum Samples From Individuals Initiating Sofosbuvir for Chronic Hepatitis C for Testing (clinicaltrials.gov) - Feb 4, 2016
P=N/A, N=352, Completed, Sponsor: Hologic, Inc.
Active, not recruiting --> Completed Active, not recruiting --> Completed
- ||| Vosevi (sofosbuvir/velpatasvir/voxilaprevir) / Gilead, Sovaldi (sofosbuvir) / Gilead
Enrollment open: A Registry for Adolescent and Pediatric Participants Who Received a Gilead Hepatitis C Virus Direct Acting Antiviral (DAA) in Gilead-Sponsored Chronic Hepatitis C Infection Trials (clinicaltrials.gov) - Dec 11, 2015
P=N/A, N=500, Enrolling by invitation, Sponsor: Gilead Sciences
Active, not recruiting --> Completed Not yet recruiting --> Enrolling by invitation
- | Sovaldi (sofosbuvir) / Gilead
New P1 trial: A Bio-equivalence Study of Sofosbuvir From Elbanovir 400 mg Film Coated Tablets ( Multi-Apex Pharma, Egypt) & Sovaldi 400 mg Film Coated Tablets (Gilead Sciences, United Kingdom) (clinicaltrials.gov) - Nov 16, 2015
P1, N=24, Completed, Sponsor: Genuine Research Center, Egypt
- ||| Sovaldi (sofosbuvir) / Gilead
New trial: Safety and Efficacy of Sofosbuvir-based Regimens in Clinical Practice for the Treatment of Chronic Hepatitis C Virus Infection in India (clinicaltrials.gov) - Oct 30, 2015
P=N/A, N=600, Recruiting, Sponsor: Gilead Sciences
- || Vosevi (sofosbuvir/velpatasvir/voxilaprevir) / Gilead
Enrollment change: A Registry for Participants With Cirrhosis Who Achieve a Sustained Virologic Response Following Treatment With a Sofosbuvir-Based Regimen Without Interferon for Chronic Hepatitis C Infection (clinicaltrials.gov) - Oct 2, 2015
P=N/A, N=2000, Enrolling by invitation, Sponsor: Gilead Sciences
Not yet recruiting --> Enrolling by invitation N=1300 --> 2000
- Sovaldi (sofosbuvir) / Gilead
New trial, Metastases: Safety and Efficacy of Sofosbuvir Based Antiviral Regimen for Treating Hepatitis C in Patients With Moderate to Advanced Chronic Kidney Disease and Patients Receiving Renal Replacement Therapy (clinicaltrials.gov) - Sep 30, 2015
P=N/A, N=50, Recruiting, Sponsor: Institute of Liver and Biliary Sciences, India
- | Sovaldi (sofosbuvir) / Gilead
New P4 trial: Macrophage Activation Markers During Sofosbuvir-based Treatment Regimes of Chronic Hepatitis C (clinicaltrials.gov) - Aug 19, 2015
P4, N=80, Recruiting, Sponsor: University of Aarhus
- ||| Vosevi (sofosbuvir/velpatasvir/voxilaprevir) / Gilead, Sovaldi (sofosbuvir) / Gilead
New trial: A Registry for Adolescent and Pediatric Participants Who Received a Gilead Hepatitis C Virus Direct Acting Antiviral (DAA) in Gilead-Sponsored Chronic Hepatitis C Infection Trials (clinicaltrials.gov) - Jul 29, 2015
P=N/A, N=500, Not yet recruiting, Sponsor: Gilead Sciences
- Sovaldi (sofosbuvir) / Gilead
New P1 trial: A Study of Sofosbuvir From Heterosofir 400 mg F.C.T (Pharmed Healthcare, Egypt) & Sovaldi 400 mg F.C.T ( Gilead Sciences, Ireland) (clinicaltrials.gov) - Jul 8, 2015
P1, N=24, Completed, Sponsor: Genuine Research Center, Egypt
- ||||| Zepatier (grazoprevir/elbasvir) / Merck (MSD)
Enrollment closed: Efficacy and Safety of Combination Grazoprevir (MK-5172)/Elbasvir (MK-8742) Versus Sofosbuvir + Pegylated Interferon + Ribavirin in Hepatitis C Virus Genotype 1, 4 or 6 Infection (MK-5172-077) (clinicaltrials.gov) - May 21, 2015
P3, N=244, Active, not recruiting, Sponsor: Merck Sharp & Dohme Corp.
N=1300 --> 2000 Recruiting --> Active, not recruiting
- || Zepatier (grazoprevir/elbasvir) / Merck (MSD)
Trial primary completion date: Efficacy and Safety of Grazoprevir (MK-5172), Elbasvir (MK-8742), and Sofosbuvir for Chronic Infection With Hepatitis C Virus Genotypes 1 and 3 (MK-5172-074) (clinicaltrials.gov) - Apr 14, 2015
P2, N=140, Active, not recruiting, Sponsor: Merck Sharp & Dohme Corp.
Recruiting --> Active, not recruiting Trial primary completion date: Jan 2015 --> Nov 2015