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NCT02468648 · ClinicalTrials.gov registry record · Phase 2
Viral Kinetics, Interferon Stimulated Genes (ISGs) and mirRNA Among Subjects Infected With Different Hepatitis C Virus Genotypes During Therapy With Sofosbuvir and GS-5816
A Phase 2 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 2
- Development phase
- 72
- Enrollment target
NCT02468648: Completed Phase 2 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
NCT02468648 is a Phase 2 study that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 72 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (46% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02468648, a Phase 2 study, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 72 participants
- Enrollment target
Study Summary
Background: \- Chronic hepatitis C is a serious liver disease. Current treatments have side effects. New drugs have been developed, but they work better in some people than others. Researchers want to learn why. Objective: \- To learn why new hepatitis C drugs sometimes do not work. Also, to learn if these drugs are safe and how well they work in people with different virus strains. Eligibility: \- Adults age 18 and older who are infected with hepatitis C virus genotypes 1-4 and who have either never been treated or treated previously with an interferon regimen (with or without ribavirin) that failed to clear the virus. Design: * Participants will be screened with medical history and physical exam. They will have blood and urine tests and complete questionnaires. * Participants will have a Fibroscan, an ultrasound that measures liver stiffness and other liver scans. They will have an electrocardiogram. * Eligible participants will have a liver biopsy. * Participants will be admitted to the Clinical Center. They will have a physical exam and blood tests, and complete questionnaires. * They will take the first study drug dose as a tablet taken once daily. * Participants will take the drug at home for 12 weeks. * Participants will have 6 study visits. They will have blood and vital signs taken, and complete questionnaires. * At week 4, participants will have another liver biopsy. * After their last drug dose, participants will have 5 follow-up visits. They will have blood and vital signs taken, and complete questionnaires. They will discuss their medications and side effects. They may have another Fibroscan.
Primary Outcome
Absence of detectable virus 12 weeks after completion of antiviral therapy
Interventions
- DRUG Sofosbuvir
- DRUG GS-5816
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2015-06-09 |
| Est. Completion | 2018-09-14 |
| Phase | Phase 2 |
What the finished NCT02468648 record still lists
NCT02468648 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (46% lower).
The record links to 0 conditions, and to 2 interventions - of which Sofosbuvir is the first listed.
NCT02468648 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02468648 about?
NCT02468648 is a clinical study titled "Viral Kinetics, Interferon Stimulated Genes (ISGs) and mirRNA Among Subjects Infected With Different Hepatitis C Virus Genotypes During Therapy With Sofosbuvir and GS-5816". Background: \- Chronic hepatitis C is a serious liver disease. Current treatments have side effects. New drugs have been developed, but they work better in some people than others. Researchers want to learn why. Objective: \- To learn why new hepatitis C drugs sometimes do not work. Also, to lear...
What is the current status of trial NCT02468648?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 72 participants. The study started on 2015-06-09. Estimated completion is 2018-09-14.
What interventions are being tested in trial NCT02468648?
The interventions under investigation include: Sofosbuvir (DRUG), GS-5816 (DRUG).
Who is sponsoring clinical trial NCT02468648?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02468648's enrollment target sits among peer trials
72 925th of 2000 higher than 1,065 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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