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54 Diseases |  |
8 Trials |
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8 Trials |  |
2662 News |  |
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- |||| ledipasvir/sofosbuvir / Generic mfg.
Enrollment open: Ledipasvir/Sofosbuvir in Adults With Chronic Hepatitis C Virus (HCV) Infection Who Are on Dialysis for End Stage Renal Disease (clinicaltrials.gov) - Jul 5, 2017
P2, N=100, Recruiting, Sponsor: Gilead Sciences
Not yet recruiting --> Recruiting
- ledipasvir/sofosbuvir / Generic mfg.
Trial primary completion date: Egypt Peds: Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed Dose Combination in the Treatment of Hepatitis C Virus (HCV) Infection in Pediatric Participants Undergoing Cancer Chemotherapy (clinicaltrials.gov) - Jul 2, 2017
P2, N=40, Recruiting, Sponsor: Gilead Sciences
Not yet recruiting --> Recruiting Trial primary completion date: Apr 2018 --> Jan 2019
- ||||||| ribavirin / Generic mfg., ledipasvir/sofosbuvir / Generic mfg.
Trial completion: Efficacy and Safety of Ledipasvir/Sofosbuvir, With or Without Ribavirin, in HCV Infected Participants Who Have Failed Prior Treatment With Sofosbuvir-based Therapies (clinicaltrials.gov) - Jun 29, 2017
P3b, N=87, Completed, Sponsor: Gilead Sciences
Trial primary completion date: Apr 2018 --> Jan 2019 Active, not recruiting --> Completed
- | ribavirin / Generic mfg.
Trial completion: 12 Weeks of Ledipasvir (LDV)/Sofosbuvir (SOF) With Weight-based Ribavirin vs. 24 Weeks of LDV/SOF (clinicaltrials.gov) - Jun 16, 2017
P2, N=7, Completed, Sponsor: AIDS Clinical Trials Group
Active, not recruiting --> Completed Active, not recruiting --> Completed
- | ribavirin / Generic mfg., ledipasvir/sofosbuvir / Generic mfg.
Trial completion: SWIFT-C: Sofosbuvir-Containing Regimens Without Interferon For Treatment of Acute Hepatitis C Virus (HCV) Infection (clinicaltrials.gov) - Jun 16, 2017
P1, N=44, Completed, Sponsor: AIDS Clinical Trials Group
Active, not recruiting --> Completed Active, not recruiting --> Completed
- | ledipasvir/sofosbuvir / Generic mfg.
Journal: Effectiveness of Ledipasvir-Sofosbuvir Combination in Patients With Hepatitis C Virus Infection and Factors Associated of Sustained Virologic Response. (Pubmed Central) - Jun 8, 2017
P=N/A
ClinicalTrials.gov no. NCT01474811.
- ledipasvir/sofosbuvir / Generic mfg.
Enrollment open: Sofosbuvir/Ledipasvir for Hepatitis C Genotype 1-6 in Patients With Transfusion-Dependent Thalassemia: An Open Label Trial (clinicaltrials.gov) - Jun 7, 2017
P4, N=10, Recruiting, Sponsor: Ala'a Sharara
NCT01474811. Not yet recruiting --> Recruiting
- | daclatasvir/sofosbuvir / Generic mfg., ledipasvir/sofosbuvir / Generic mfg.
New trial: The Effect of Direct Antiviral Therapy on Hepatitis c Virus-related Thrombocytopenia (clinicaltrials.gov) - May 30, 2017
P=N/A, N=50, Not yet recruiting, Sponsor: Assiut University
- ||||||| ledipasvir/sofosbuvir / Generic mfg.
Trial completion: Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Participants With Chronic Genotype 2 HCV Infection (clinicaltrials.gov) - May 23, 2017
P3b, N=239, Completed, Sponsor: Gilead Sciences
Not yet recruiting --> Recruiting Active, not recruiting --> Completed
- || 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
Active, not recruiting --> Completed Trial primary completion date: Nov 2022 --> May 2024
- | ledipasvir/sofosbuvir / Generic mfg.
Trial completion, Enrollment change, Trial initiation date, Trial primary completion date: Program of Screening, Prevention and Elimination of Hepatitis C in Penitentiary Institutions in Cantabria (JAILFREE-C) (clinicaltrials.gov) - May 18, 2017
P4, N=64, Completed, Sponsor: Instituto de Investigaci
Trial primary completion date: Nov 2022 --> May 2024 Recruiting --> Completed | N=120 --> 64 | Initiation date: Feb 2016 --> May 2016 | Trial primary completion date: Sep 2018 --> May 2017
- | ledipasvir/sofosbuvir / Generic mfg.
Journal: Treatment With Ledipasvir-Sofosbuvir for 12 or 24 Weeks in Kidney Transplant Recipients With Chronic Hepatitis C Virus Genotype 1 or 4 Infection: A Randomized Trial. (Pubmed Central) - May 14, 2017
P2
Treatment with ledipasvir-sofosbuvir for 12 or 24 weeks was well-tolerated and seemed to have an acceptable safety profile among kidney transplant recipients with HCV genotype 1 or 4 infection, all of whom achieved SVR12. Gilead Sciences.
- | Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead
Enrollment closed, Trial primary completion date: CTN289: HIV Drug Switch Followed by HCV Therapy in HIV-HCV Co-Infection (clinicaltrials.gov) - Apr 26, 2017
P3, N=25, Active, not recruiting, Sponsor: Ottawa Hospital Research Institute
Gilead Sciences. Recruiting --> Active, not recruiting | Trial primary completion date: Jul 2017 --> Nov 2017
- ||||| ribavirin / Generic mfg., ledipasvir/sofosbuvir / Generic mfg.
Enrollment change: Efficacy and Safety of Ledipasvir/Sofosbuvir, With or Without Ribavirin, in HCV Infected Participants Who Have Failed Prior Treatment With Sofosbuvir-based Therapies (clinicaltrials.gov) - Apr 25, 2017
P3b, N=87, Active, not recruiting, Sponsor: Gilead Sciences
Recruiting --> Active, not recruiting | Trial primary completion date: Jul 2017 --> Nov 2017 N=300 --> 87
- | ledipasvir/sofosbuvir / Generic mfg.
New P4 trial: Effects of Ledipasvir/Sofosbuvir on the Pharmacokinetics and Renal Safety of Tenofovir Alafenamide (TAF) (clinicaltrials.gov) - Apr 24, 2017
P4, N=15, Not yet recruiting, Sponsor: University of Colorado, Denver
- | ledipasvir/sofosbuvir / Generic mfg.
New P2 trial: Harvoni Treatment Porphyria Cutanea Tarda (clinicaltrials.gov) - Apr 17, 2017
P2, N=49, Not yet recruiting, Sponsor: Herbert L. Bonkovsky, MD
- | Pegasys (pegylated interferon α -2a) / Roche, Daklinza (daclatasvir) / BMS, ledipasvir/sofosbuvir / Generic mfg.
Journal: Hepatitis C virus genotype 3: Meta-analysis on sustained virologic response rates with currently available treatment options. (Pubmed Central) - Apr 12, 2017
N=300 --> 87 Lastly, SOF + DCV combination is probably the best oral therapy option and the addition of RBV does not appear to be needed to increase SVR rates substantially.
- | ribavirin / Generic mfg., ledipasvir/sofosbuvir / Generic mfg.
Enrollment closed: Feasibility, Tolerance and Efficacy of Interferon-free, Antiviral Treatment With Sofosbuvir + Ribavirin for the Treatment of Genotype 2 and Sofosbuvir/Ledipasvir for the Treatment of Genotype 1 and 4 Hepatitis C Virus-infected Patients in West and Central Africa (clinicaltrials.gov) - Apr 10, 2017
P2, N=120, Active, not recruiting, Sponsor: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Lastly, SOF + DCV combination is probably the best oral therapy option and the addition of RBV does not appear to be needed to increase SVR rates substantially. Recruiting --> Active, not recruiting
- | ribavirin / Generic mfg., ledipasvir/sofosbuvir / Generic mfg.
Enrollment closed, Trial primary completion date: SL50: Sofosbuvir, Ledipasvir, Ribavirin for Hepatitis C Cirrhotics, Genotype 1 (clinicaltrials.gov) - Apr 7, 2017
P3, N=50, Active, not recruiting, Sponsor: Tehran University of Medical Sciences
Recruiting --> Active, not recruiting Not yet recruiting --> Active, not recruiting | Trial primary completion date: Dec 2016 --> Sep 2017
- | 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 --> Active, not recruiting | Trial primary completion date: Dec 2016 --> Sep 2017 Trial primary completion date: Jun 2016 --> Jun 2017
- | ledipasvir/sofosbuvir / Generic mfg.
Enrollment closed, Enrollment change, Trial primary completion date: Oral Hepatitis C Treatment for Indolent Lymphoma (OPTImaL) Study (clinicaltrials.gov) - Mar 24, 2017
P4, N=1, Active, not recruiting, Sponsor: University of Texas Southwestern Medical Center
Trial primary completion date: Jun 2016 --> Jun 2017 Recruiting --> Active, not recruiting | N=21 --> 1 | Trial primary completion date: Feb 2018 --> Jun 2017
- | Daklinza (daclatasvir) / BMS, ledipasvir/sofosbuvir / Generic mfg.
Review, Journal: Developing therapies to treat hepatitis C infection in post-liver transplant recipients. (Pubmed Central) - Mar 1, 2017
Expert Opinion: While there are many potential available therapies for HCV recurrence in the post-liver transplant setting, daclatasvir/sofosbuvir and ledipasvir/sofosbuvir have been the most extensively studied. Newer, pangenotypic generation drugs require more evidence before routine utilization in post-liver transplant recipients.
- | ribavirin / Generic mfg., ledipasvir/sofosbuvir / Generic mfg.
Enrollment closed: Sofosbuvir Plus Ribavirin, or Ledipasvir/Sofosbuvir in Adults With HCV Infection and Renal Insufficiency (clinicaltrials.gov) - Feb 28, 2017
P2b, N=38, Active, not recruiting, Sponsor: Gilead Sciences
Newer, pangenotypic generation drugs require more evidence before routine utilization in post-liver transplant recipients. Recruiting --> Active, not recruiting
- | daclatasvir/sofosbuvir / Generic mfg., ledipasvir/sofosbuvir / Generic mfg.
New trial: Dynamic Changes of Monocytes and NK Cells of CHC Patient Treated by DAAs (clinicaltrials.gov) - Feb 24, 2017
P=N/A, N=25, Completed, Sponsor: Third Affiliated Hospital, Sun Yat-Sen University
- | ledipasvir/sofosbuvir / Generic mfg.
Trial primary completion date, IO biomarker: Immunologic Effects of HCV Therapy With HARVONI in HCV Genotype 1 Chronically Mono-infected Active and Former IDUs (clinicaltrials.gov) - Feb 24, 2017
P4, N=36, Active, not recruiting, Sponsor: Rockefeller University
Recruiting --> Active, not recruiting Trial primary completion date: Jan 2017 --> Jan 2018
- || ledipasvir/sofosbuvir / Generic mfg.
Enrollment closed: Use-Results Surveillance Study of Harvoni (clinicaltrials.gov) - Feb 24, 2017
P=N/A, N=3000, Active, not recruiting, Sponsor: Gilead Sciences
Trial primary completion date: Jan 2017 --> Jan 2018 Recruiting --> Active, not recruiting
- ||||||| ribavirin / Generic mfg., ledipasvir/sofosbuvir / Generic mfg.
Trial completion: Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination, With or Without Ribavirin, in Egyptian Adults With Chronic Genotype 4 HCV Infection (clinicaltrials.gov) - Feb 23, 2017
P3, N=255, Completed, Sponsor: Gilead Sciences
Recruiting --> Active, not recruiting Active, not recruiting --> Completed
- | ribavirin / Generic mfg., ledipasvir/sofosbuvir / Generic mfg.
New P3 trial: HepCC-2: Treatment of Hepatitis C Virus Infection With Generic Sofosbuvir/Ledipasvir in Iranian Patients (clinicaltrials.gov) - Feb 23, 2017
P3, N=200, Not yet recruiting, Sponsor: Iran Hepatitis Network
- | sofosbuvir/velpatasvir / Generic mfg., daclatasvir/sofosbuvir / Generic mfg., ledipasvir/sofosbuvir / Generic mfg.
Enrollment open: REDEMPTION: Reviewing DAA Efficacy Managing Patient Treatment In Online Neighbourhoods (clinicaltrials.gov) - Feb 16, 2017
P=N/A, N=10000, Enrolling by invitation, Sponsor: FixHepC
Active, not recruiting --> Completed Active, not recruiting --> Enrolling by invitation
- sofosbuvir/velpatasvir / Generic mfg., daclatasvir/sofosbuvir / Generic mfg., ledipasvir/sofosbuvir / Generic mfg.
Enrollment closed, Trial primary completion date: REDEMPTION: Reviewing DAA Efficacy Managing Patient Treatment In Online Neighbourhoods (clinicaltrials.gov) - Feb 15, 2017
P=N/A, N=10000, Active, not recruiting, Sponsor: FixHepC
Active, not recruiting --> Enrolling by invitation Enrolling by invitation --> Active, not recruiting | Trial primary completion date: Jun 2017 --> Jan 2017
- ||||| ledipasvir/sofosbuvir / Generic mfg.
Enrollment closed: Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Participants With Chronic Genotype 1 HCV Infection (clinicaltrials.gov) - Feb 8, 2017
P3b, N=384, Active, not recruiting, Sponsor: Gilead Sciences
Enrolling by invitation --> Active, not recruiting | Trial primary completion date: Jun 2017 --> Jan 2017 Recruiting --> Active, not recruiting
- ||| Zepatier (grazoprevir/elbasvir) / Merck (MSD), Viekira Pak (ombitasvir/paritaprevir/ritonavir/dasabuvir) / AbbVie, Enanta Pharma, Exviera (dasabuvir) / AbbVie
Phase classification, Enrollment change: PRIORITIZE: Study of Oral Treatments for Hepatitis C (clinicaltrials.gov) - Feb 7, 2017
P4, N=2670, Recruiting, Sponsor: University of Florida
Recruiting --> Active, not recruiting Phase classification: P=N/A --> P4 | N=3750 --> 2670
- ribavirin / Generic mfg.
Enrollment closed, Enrollment change: 12 Weeks of Ledipasvir (LDV)/Sofosbuvir (SOF) With Weight-based Ribavirin vs. 24 Weeks of LDV/SOF (clinicaltrials.gov) - Feb 6, 2017
P2, N=7, Active, not recruiting, Sponsor: AIDS Clinical Trials Group
Phase classification: P=N/A --> P4 | N=3750 --> 2670 Recruiting --> Active, not recruiting | N=40 --> 7
- || ledipasvir/sofosbuvir / Generic mfg.
Trial primary completion date, Adherence: Evaluation of HepCure Toolkit to Improve Harvoni Adherence (clinicaltrials.gov) - Feb 1, 2017
P=N/A, N=99, Recruiting, Sponsor: Icahn School of Medicine at Mount Sinai
Recruiting --> Active, not recruiting | N=40 --> 7 Trial primary completion date: Feb 2017 --> Dec 2017
- ||||| Genvoya (elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide) / Gilead, Odefsey (emtricitabine/rilpivirine/tenofovir alafenamide) / J&J, Gilead
Enrollment closed, Enrollment change: Co-STARs: Efficacy, Safety, and Tolerability of Ledipasvir/Sofosbuvir (LDV/SOF) Treatment for HIV/HCV Co-infected Participants Who Switch to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) or Emtricitabine/Rilpivirine/Tenofovir Alafenamide (F/R/TAF) Prior to LDV/SOF HCV Treatment (clinicaltrials.gov) - Jan 30, 2017
P3b, N=150, Active, not recruiting, Sponsor: Gilead Sciences
Trial primary completion date: Feb 2017 --> Dec 2017 Recruiting --> Active, not recruiting | N=240 --> 150
- ||||| ledipasvir/sofosbuvir / Generic mfg.
New P2 trial: Ledipasvir/Sofosbuvir in Adults With Chronic Hepatitis C Virus (HCV) Infection Who Are on Dialysis for End Stage Renal Disease (clinicaltrials.gov) - Jan 30, 2017
P2, N=100, Not yet recruiting, Sponsor: Gilead Sciences
- ledipasvir/sofosbuvir / Generic mfg.
New P4 trial: Sofosbuvir/Ledipasvir for Hepatitis C Genotype 1-6 in Patients With Transfusion-Dependent Thalassemia: An Open Label Trial (clinicaltrials.gov) - Jan 26, 2017
P4, N=10, Not yet recruiting, Sponsor: Ala'a Sharara
- | Zepatier (grazoprevir/elbasvir) / Merck (MSD), Viekira Pak (ombitasvir/paritaprevir/ritonavir/dasabuvir) / AbbVie, Enanta Pharma, Exviera (dasabuvir) / AbbVie
Phase classification: PRIORITIZE: Study of Oral Treatments for Hepatitis C (clinicaltrials.gov) - Jan 26, 2017
P=N/A, N=3750, Recruiting, Sponsor: University of Florida
Recruiting --> Active, not recruiting | N=240 --> 150 Phase classification: P4 --> P=N/A
- |||| Zepatier (grazoprevir/elbasvir) / Merck (MSD)
Trial completion: Elbasvir/Grazoprevir (EBR/GZR) and Sofosbuvir (SOF) With and Without Ribavirin (RBV) in Cirrhotic Subjects With Chronic Hepatitis C Virus (HCV) Genotype 3 (GT3) Infection (MK-5172-083) (clinicaltrials.gov) - Jan 23, 2017
P2, N=101, Completed, Sponsor: Merck Sharp & Dohme Corp.
Phase classification: P4 --> P=N/A Active, not recruiting --> Completed
- ||| ledipasvir/sofosbuvir / Generic mfg.
Enrollment open: Harvoni in Patients With Chronic Hepatitis C Virus (HCV) Infection in Korea (clinicaltrials.gov) - Jan 19, 2017
P=N/A, N=3000, Recruiting, Sponsor: Gilead Sciences
Active, not recruiting --> Completed Not yet recruiting --> Recruiting
- 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
Not yet recruiting --> Recruiting Trial primary completion date: Dec 2016 --> Dec 2017
- daclatasvir/sofosbuvir / Generic mfg., ledipasvir/sofosbuvir / Generic mfg.
Trial primary completion date: Sofosbuvir Containing Regimens for the Treatment of Chronic HCV GT3 Infected Patients (clinicaltrials.gov) - Jan 18, 2017
P3, N=60, Recruiting, Sponsor: Humanity & Healthy GI and Liver Centre
Trial primary completion date: Dec 2016 --> Dec 2017 Trial primary completion date: Sep 2016 --> Sep 2017
- Daklinza (daclatasvir) / BMS
Trial primary completion date: Sofosbuvir Containing Regimens for the Treatment of Chronic HCV GT2 Infected Patients (clinicaltrials.gov) - Jan 18, 2017
P4, N=120, Recruiting, Sponsor: Humanity & Healthy GI and Liver Centre
Trial primary completion date: Sep 2016 --> Sep 2017 Trial primary completion date: Dec 2016 --> Dec 2017
- ribavirin / Generic mfg., ledipasvir/sofosbuvir / Generic mfg.
Trial primary completion date: Feasibility, Tolerance and Efficacy of Interferon-free, Antiviral Treatment With Sofosbuvir + Ribavirin for the Treatment of Genotype 2 and Sofosbuvir/Ledipasvir for the Treatment of Genotype 1 and 4 Hepatitis C Virus-infected Patients in West and Central Africa (clinicaltrials.gov) - Jan 12, 2017
P2, N=120, Recruiting, Sponsor: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Trial primary completion date: Dec 2016 --> Dec 2017 Trial primary completion date: Nov 2016 --> Jun 2017
- | ledipasvir/sofosbuvir / Generic mfg.
Enrollment open, Trial initiation date, Metastases: Hepatitis C Virus(HCV) Heart and Lung Study (clinicaltrials.gov) - Jan 4, 2017
P4, N=50, Recruiting, Sponsor: Duke University
Trial primary completion date: Nov 2016 --> Jun 2017 Not yet recruiting --> Recruiting | Initiation date: Sep 2016 --> Dec 2016
- | ledipasvir/sofosbuvir / Generic mfg.
New P1 trial: A Study of Sofosbuvir and Ledipasvir From Magicbuvir Plus 90/400 mg Tablets (Magic Pharma, Egypt) Versus Harvoni 90/400 mg Tablets (Gilead Sciences, USA) (clinicaltrials.gov) - Dec 28, 2016
P1, N=37, Completed, Sponsor: Genuine Research Center, Egypt
- || ledipasvir/sofosbuvir / Generic mfg.
Trial primary completion date: Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination +/- Ribavirin in Adolescents and Children With Chronic HCV-Infection (clinicaltrials.gov) - Dec 28, 2016
P2, N=200, Recruiting, Sponsor: Gilead Sciences
Not yet recruiting --> Recruiting | Initiation date: Sep 2016 --> Dec 2016 Trial primary completion date: Jan 2018 --> May 2018
- | 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
- ledipasvir/sofosbuvir / Generic mfg.
Trial primary completion date: Egypt Peds: Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed Dose Combination in the Treatment of Hepatitis C Virus (HCV) Infection in Pediatric Participants Undergoing Cancer Chemotherapy (clinicaltrials.gov) - Dec 12, 2016
P2, N=40, Recruiting, Sponsor: Gilead Sciences
Trial primary completion date: Jan 2018 --> May 2018 Trial primary completion date: Nov 2017 --> Apr 2018
- | ledipasvir/sofosbuvir / Generic mfg.
New P4 trial: SHARED: Simplifying Hepatitis C Antiviral Therapy in Rwanda for Elsewhere in the Developing World (clinicaltrials.gov) - Nov 14, 2016
P4, N=300, Recruiting, Sponsor: Partners in Health