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Clinical Trial Details

Trial ID: L1335
Source ID: NCT03883698
Associated Drug: Sofosbuvir
Title: Safety of Sofosbuvir in People With Advanced Kidney Failure
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Kidney Failure, Chronic|Hepatitis C
Interventions: DRUG: Sofosbuvir|DRUG: Daclatasvir 60 mg
Outcome Measures: Primary: Pharmacokinetics study, To study the Maximum Plasma Concentration \[Cmax\] of sofosbuvir and its metabolite (GS-331007) in participants with eGFR below 30 ml/min who are treated with low-dose of sofosbuvir and compare it with that in people with normal eGFR., At hour (from the time of drug administration) '0', 0.25, 0.5, 1, 2, 4, 8, 12, 16, 24 on Day 1; hour 36 on Day 2; at hour 84 on Day 4; and at hour 156 on Day 7|Pharmacokinetics study, To study the Area Under the Curve \[AUC\] of sofosbuvir and its metabolite (GS-331007) in participants with eGFR below 30 ml/min who are treated with low-dose of sofosbuvir and compare it with that in people with normal eGFR., At hour (from the time of drug administration) '0', 0.25, 0.5, 1, 2, 4, 8, 12, 16, 24 on Day 1; hour 36 on Day 2; at hour 84 on Day 4; and at hour 156 on Day 7|Pharmacokinetics study, To study the Terminal Half Life \[t1/2\] of sofosbuvir and its metabolite (GS-331007) in participants with eGFR below 30 ml/min who are treated with low-dose of sofosbuvir and compare it with that in people with normal eGFR., At hour (from the time of drug administration) '0', 0.25, 0.5, 1, 2, 4, 8, 12, 16, 24 on Day 1; hour 36 on Day 2; at hour 84 on Day 4; and at hour 156 on Day 7 | Secondary: Clinical response, Proportion of participants with sustained virologic response at 12 weeks \[SVR12\] after discontinuation of anti-HCV treatment, 12 weeks after stopping anti-HCV treatment
Sponsor/Collaborators: Sponsor: Sanjay Gandhi Postgraduate Institute of Medical Sciences
Gender: ALL
Age: ADULT
Phases: PHASE3
Enrollment: 30
Study Type: INTERVENTIONAL
Study Designs: Allocation: NON_RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: BASIC_SCIENCE
Start Date: 2019-03-15
Completion Date: 2020-08-01
Results First Posted:
Last Update Posted: 2021-04-06
Locations: Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow, Uttar Pradesh, 226014, India
URL: https://clinicaltrials.gov/show/NCT03883698