11 completed. 11 Phase 1, 3 Phase 2.
By phase and status
Follow Sofosbuvir: new trials by email Literature Review of Sofosbuvir trials Research Report on Sofosbuvir
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All 11 trials
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
The Tolerability, Pharmacokinetics and Pharmacodynamics Study of HEC110114 Tablets in HCV-infected Subjects HEC110114 Tablet, Sofosbuvir Tablet - Chronic Hepatitis C | Phase 1 / Phase 2 | Completed | 24 | 2020-07-06 | 2020-09-10 |
A Study of the Relative Bioavailability of ASC18 Tablets vs Reference Tablets in Healthy Volunteers ASC18, ravidasvir and sofosbuvir - Healthy | Phase 1 | Completed | 50 | 2020-03-20 | 2021-01-11 |
Study to Evaluate the Safety and PK of Elpida® in Healthy Subjects and Patients With Hepatic Impairment and to Assess the Impact of Food Intake and Drug-Drug Interactions With Other Antiviral Drugs Elpida®, Dolutegravir, Sofosbuvir - HIV-1-infection, Hepatic Impairment | Phase 1 | Completed | 36 | 2018-10-01 | 2022-01-11 |
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) Sofodelevier, Sovaldi (fist dose), Sovaldi (second dose) - Healthy | Phase 1 | Completed | 36 | 2016-10-01 | 2019-08-01 |
A Bio-equivalence Study of Sofosbuvir From Magicbuvir 400 mg Film Coated Tablets ( Magic Pharma, Egypt) Versus Sovaldi 400 mg Tablets (Gilead Sciences, Canada) Magicbuvir, Sovaldi (fist dose), Sovaldi (second dose) - Healthy | Phase 1 | Completed | 36 | 2016-05-01 | 2016-11-02 |
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) Elbanovir, Sovaldi - Healthy | Phase 1 | Completed | 24 | 2015-08-01 | 2015-11-16 |
A Study of Sofosbuvir From Heterosofir 400 mg F.C.T (Pharmed Healthcare, Egypt) & Sovaldi 400 mg F.C.T ( Gilead Sciences, Ireland) Heterosofir, Sovaldi - Healthy | Phase 1 | Completed | 24 | 2015-02-01 | 2015-07-08 |
Sofosbuvir-Containing Regimens Without Interferon For Treatment of Acute Hepatitis C Virus (HCV) Infection Sofosbuvir, Ribavirin, Ledipasvir/Sofosbuvir - HIV-1 Infection, Hepatitis | Phase 1 | Completed | 44 | 2014-05-30 | 2018-04-27 |
Part A: Drug Interaction Study of Sofosbuvir and Antiretroviral Therapy (ART) Combinations in HIV and Hepatitis C Virus (HCV) Co-infected Patients. Part B: Efficacy and Safety of Sofosbuvir for 12 Weeks in HIV/HCV Co-infected Patients. SOF, EFV/FTC/TDF, EFV - Hepatitis C, HIV | Phase 1 / Phase 2 | Completed | 52 | 2012-03-01 | 2014-10-01 |
GS-7977 With Ribavirin for Hepatitis C (SPARE) GS7977, RBV - Hepatitis C | Phase 1 / Phase 2 | Completed | 60 | 2011-09-01 | 2014-09-26 |
Open-Label Hepatic Impairment Study PSI-352938, PSI-7977 - Hepatitis C | Phase 1 | Completed | 24 | 2011-07-01 | 2012-06-08 |
Conditions studied
Hepatitis C (3) · Hepatitis C, Chronic (2) · Hepatitis (1)
Sponsors
Genuine Research Center, Egypt (4) · Gilead Sciences (2) · Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections (1) · Ascletis Pharmaceuticals Co., Ltd. (1) · National Institute of Allergy and Infectious Diseases (NIAID) (1) · Sunshine Lake Pharma Co., Ltd. (1) · Viriom (1)
Countries
Egypt (4) · United States (3) · China (2) · Puerto Rico (2) · Russia (1)
Top investigators
Ahmed Elshafeey, Ph.D. Pharma (4) · Alla Andreeva, PhD (1) · Anuj Gaggar, MD/PhD (1) · Junqi Niu, Doctor (1) · Raymond T Chung, M.D. (1) · Shyamasundaran Kottilil, M.D. (1) · Susanna Naggie, M.D. (1) · Yahong Chen, MD (1) · Yanhua Ding, Doctor (1)
Results publications
PMID 23982366, PMID 24983321, PMID 25622055, PMID 25733369, PMID 28329053, PMID 31220220
NIH funding
UM1AI068636 (1)