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NCT01958281 · ClinicalTrials.gov registry record · Phase 2
Sofosbuvir Plus Ribavirin, or Ledipasvir/Sofosbuvir in Adults With HCV Infection and Renal Insufficiency
A Phase 2 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 2
- Development phase
- 38
- Enrollment target
NCT01958281 is a Phase 2 study that has completed, run by Gilead Sciences. The registered enrollment target is 38 participants.
The verdict
NCT01958281, a Phase 2 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 38 participants
- Enrollment target
Study Summary
The primary objectives of this study are to evaluate the safety and efficacy of sofosbuvir (SOF) plus ribavirin (RBV) for 24 weeks and ledipasvir/sofosbuvir (LDV/SOF) for 12 weeks, and to evaluate the steady state pharmacokinetics (PK) of SOF and its metabolites and LDV in participants with genotype (GT) 1, 3, or 4 hepatitis C virus (HCV) infection who have chronic renal insufficiency (impaired kidney function).
Interventions
- DRUG SOF
- DRUG RBV
- DRUG LDV/SOF
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2013-10-07 |
| Est. Completion | 2017-10-19 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01958281
The ClinicalTrials.gov registry entry for NCT01958281 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gilead Sciences, which has 504 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which SOF is the first listed.
NCT01958281 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01958281 about?
NCT01958281 is a clinical study titled "Sofosbuvir Plus Ribavirin, or Ledipasvir/Sofosbuvir in Adults With HCV Infection and Renal Insufficiency". The primary objectives of this study are to evaluate the safety and efficacy of sofosbuvir (SOF) plus ribavirin (RBV) for 24 weeks and ledipasvir/sofosbuvir (LDV/SOF) for 12 weeks, and to evaluate the steady state pharmacokinetics (PK) of SOF and its metabolites and LDV in participants with genotype...
What is the current status of trial NCT01958281?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 38 participants. The study started on 2013-10-07. Estimated completion is 2017-10-19.
What interventions are being tested in trial NCT01958281?
The interventions under investigation include: SOF (DRUG), RBV (DRUG), LDV/SOF (DRUG).
Who is sponsoring clinical trial NCT01958281?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
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