| ledipasvir/sofosbuvir / Generic mfg. |
2015-003024-31: Protecting immune responses in patients treated with the new DAA anti hepatitis C alone or in combination with previously used medications (interferon and ribavirin) Risposte immunitarie proteggenti in pazienti trattati con i nuovi farmaci anti epatite C (nuovi DAA) da soli o in associazione con i farmaci precedentemente utilizzati (interferone e ribavirina) |
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| Not yet recruiting | 4 | 30 | Europe | PEGINTERFERONE ALFA-2A, RIBAVIRINA, SOFOSBUVIR, LEDIPASVIR+SOFOSBUVIR, N.A., Solution for injection, Capsule, hard, Film-coated tablet, PEGASYS - 180MCG-SOLUZ. INIETTABILE-USO SOTTOCUT.-PENNA PRERIEMPITA-0.5 ML (360MCG/ML) 1 PENNA PRERIEMPITA, REBETOL - 200 MG 84 CAPSULE RIGIDE IN BLISTER, SOVALDI - 400 MG - COMPRESSA RIVESTITA CON FILM - FLACONE (HDPE) - 28 COMPRESSE, HARVONI - 90 MG/400 MG - COMPRESSE RIVESTITE CON FILM - USO ORALE - FLACONE (HDPE) - 28 COMPRESSE RIVESTITE CON FILM | AZIENDA OSPEDALIERO-UNIVERSITARIA DI PARMA, GILEAD SCIENCES SRL | CHRONIC HEPATITIS C EPATITE C CRONICA, CHRONIC HEPATITIS C EPATITE C CRONICA, Diseases [C] - Virus Diseases [C02] | | | | |
ChiCTR-OPC-16008158: Safety and efficacy of sofosbuvir plus ledipasvir for Chinese hepatitis C patients |
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| Recruiting | 4 | 100 | | sofosbuvir, ledipasvir and ribavirin ;sofosbuvir, ledipasvir and ribavirin ;sofosbuvir, ledipasvir | The First Affiliated Hospital of Zhengzhou University; The First Affiliated Hospital of Zhengzhou University, Key Scientific Research Project of Henan Higher Education Institutions of China (No. 15A320083) | Chronic hepatitis C | | | | |
NCT03402165: Serum Alpha-fetoprotein Levels and Response to Direct Antiviral Therapy in Patients With Chronic Hepatitis C |
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| Recruiting | 4 | 1200 | RoW | Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir, Sofaldy, Harvony | Sherief Abd-Elsalam | Hepatitis C | 12/22 | 12/22 | | |
CHROME, NCT03823911: Cardiovascular Disease in HIV and Hepatitis C: Risk Outcomes After Hepatitis C Eradication |
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| Completed | 4 | 87 | US | Elbasvir / Grazoprevir Oral Tablet [Zepatier], Sofosbuvir/Ledipasvir, Sofosbuvir/Velpatasvir, Glecaprevir/Pibrentasvir, Sofosbuvir/Velpatasvir/Voxilaprevir, Cardiac MRI | University of Maryland, Baltimore, National Institutes of Health (NIH), Merck Sharp & Dohme LLC | Cardiovascular Diseases, Hepatitis C, Hiv | 12/22 | 12/22 | | |
| Recruiting | 3 | 0 | Tehran | Cimivir-L (ledipasvir/sofosbuvir) - Gilead, Tehran University of Medical Sciences | Gilead, Tehran University of Medical Sciences | | | | | |
2016-002958-21: Study HCV-art: An Open-Label, pilot Study, to Explore the Clinical Safety and Efficacy of Sofosbuvir/Ledipasvir in Hepatitis C Virus (HCV) Chronic Patients with Arthritis Studio pilota, monocentrico, in aperto, per valutare sicurezza ed efficacia della combinazione sofosbuvir/ledipasvir in pazienti con epatite C cronica, genotipo 1, affetti da artrite cronica |
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| Not yet recruiting | 3 | 50 | Europe | HARVONI, RIBAVIRINA, J05AX65, RIBAVIRINA, Film-coated tablet, Capsule, hard, HARVONI - 90 MG/400 MG - COMPRESSE RIVESTITE CON FILM - USO ORALE - FLACONE (HDPE) - 28 COMPRESSE RIVESTITE CON FILM, REBETOL - 200 MG 84 CAPSULE RIGIDE IN BLISTER | AOU DI BOLOGNA POLICLINICO S.ORSOLA-MALPIGHI, Gilead | Chronic HCV associated with chronic arthritis. HCV cronica associata ad artrite cronica., Chronic HCV associated with chronic arthritis. HCV cronica associata ad artrite cronica., Diseases [C] - Virus Diseases [C02] | | | | |
NCT04353986: PK of SOF/LED in HCV - Infected Adolescents With Haematological Disorders |
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| Recruiting | 3 | 24 | RoW | Sofosbuvir and Ledipasvir, SOF/LED | Ain Shams University | HCV Infection, Beta Thalassemia Major | 04/23 | 12/23 | | |
2013-002296-17: An international study to assess the safety and efficacy of a combination of new investigational drugs in patients with chronic hepatitis C virus infection who have previously failed treatment. |
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| Not yet recruiting | 2 | 150 | Europe | Sofosbuvir/GS-5885 FDC, Ribasphere, GS-7977/GS-5885 FDC, Film-coated tablet, Ribasphere Tablets | Gilead Sciences, Inc., Gilead Sciences Inc | Chronic Genotype 1 Hepatitis C Virus Infection Adultes présentant une infection chronique par le virus de l’hépatite C (VHC) de génotype 1 et une cirrhose, et précédemment traités par un inhibiteur de protéase avec PEG+RBV., Hepatitis C Virus Infection Infection chronique par le virus de l'hépatite C de génotype 1 (correspondant à une variété du virus) chez des patients ayant déjà reçu un traitement pour cette maladie., Diseases [C] - Virus Diseases [C02] | | | | |
2013-003978-27: A study to assess the safety and efficacy of a combination of Sofosbuvir/Ledipasvir in patients with Chronic Genotype 4 or 5 hepatitis C Infection. |
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| Not yet recruiting | 2 | 80 | Europe | SOF/LDV FDC, GS-7977/GS-5885 FDC, Film-coated tablet | Gilead Sciences, Inc., Gilead Sciences Inc | Chronic Genotype 4 and Genotype 5 Hepatitis C Virus Infection, Hepatitis C Virus Infection, Diseases [C] - Virus Diseases [C02] | | | | |
2015-002401-10: Pilot multicenter open label study on treatment with Sofosbuvir/Ledipasvir FDC for patients with thalassemia major and HCV infection. Studio pilota multicentrico con LDV/SOF in pazienti con talassemia major e infezione cronica da HCV |
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| Ongoing | 2 | 100 | Europe | HARVONI, 700016355, Film-coated tablet, HARVONI - 90 MG/400 MG - COMPRESSE RIVESTITE CON FILM - USO ORALE - FLACONE (HDPE) - 28 COMPRESSE RIVESTITE CON FILM | FONDAZIONE CASA SOLLIEVO DELLA SOFFERENZA OPERA DI SAN PIO DA PIETRELCINA OSPEDALE IRCCS, IRCCS CASA SOLLIEVO DELLA SOFFERENZA | Patients with thalassemia major and HCV infection either naïve or on nucleo(s)tide analogs treatment, data on Sofosbuvir-based treatment are currently lacking, while, due to the long infection duration, this category of patients has a urgent treatment need. Pazienti con talassemia major e infezione cronica da HCV di genotipo ¼ (naïve o precedentemente trattati senza successo), Patients with thalassemia major and HCV infection either naïve or on nucleo(s)tide analogs treatment, data on Sofosbuvir-based treatment are currently lacking, while, due to the long infection duratio Pazienti con talassemia major e infezione cronica da HCV di genotipo ¼ (naïve o precedentemente trattati senza successo), Diseases [C] - Virus Diseases [C02] | | | | |
| Ongoing | 2 | 408 | Europe | Viekirax, Exviera (Dasabuvir), Harvoni, Ribavirin (film-coated 200mg), Ribavirin (hard capsule, 200mg), Ribavirin (film-coated, 400mg), Maviret, Film-coated tablet, , Viekirax, Exviera (Dasabuvir), Harvoni, Maviret | Imperial College London, NIHR Efficacy and Mechanism Evaluation Programme | Hepatitis C Infection (HCV) (genotype 1a/1b/4), Hepatitis C infection, Diseases [C] - Virus Diseases [C02] | | | | |
| Completed | 2 | 40 | Europe | Ledipasvir+Sofosbuvir, Harvoni, Sofosbuvir+Velpatasvir, Epclusa | Fondazione Italiana Linfomi ONLUS | Indolent B-cell Lymphoma, Hepatitis C | 02/20 | 11/22 | | |
| Recruiting | 2 | 160 | RoW | PR4 + LDV/SOF + ASV 4 wk, Pegasys®, Copegus®, Harvoni®, Sunvepra®, PR4 + LDV/SOF + SMV 4 wk, OLYSIO®, PR4 + LDV/SOF + ASV 6 wk, PR4 + LDV/SOF + SMV 6 wk, PR4 + LDV/SOF + ASV 8 wk, PR4 + LDV/SOF + SMV 8 wk, PR4 + LDV/SOF + ASV 12 wk, PR4 + LDV/SOF + SMV 12 wk | Humanity and Health Research Centre, Beijing 302 Hospital, Nanfang Hospital of Southern Medical University | Chronic Hepatitis C Infection | 10/22 | 12/22 | | |
NCT03903185: Pharmacokinetics of Ledipasvir/Sofosbuvir in Hepatitis C Virus-Infected Children With Hematological Malignancy |
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| Completed | 1/2 | 24 | RoW | Ledipasvir / Sofosbuvir Oral Product, LDV\SOF | Ain Shams University, Cairo University | Hepatitis C, Chronic, Hematologic Malignancy | 07/23 | 08/23 | | |
| Recruiting | N/A | 300 | Europe | Elbasvir / Grazoprevir Oral Tablet, sofosbuvir, ledipasvir | University Hospital, Akershus | Hepatitis C, Substance Use Disorders | 10/19 | 12/22 | | |
