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NCT02347345 · ClinicalTrials.gov registry record · Phase 4
Immunologic Effects of HCV Therapy With HARVONI in HCV Genotype 1 Chronically Mono-infected Active and Former IDUs
A Phase 4 study, sponsored by Rockefeller University.
- Completed
- Registry status
- Phase 4
- Development phase
- 34
- Enrollment target
NCT02347345: Completed Phase 4 study, sponsored by Rockefeller University.
NCT02347345 is a Phase 4 study that has completed, run by Rockefeller University. The registered enrollment target is 34 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02347345, a Phase 4 study, has completed, sponsored by Rockefeller University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 34 participants
- Enrollment target
Study Summary
The investigator's hypothesis is that active injectors will show a partial reduction in markers of immune activation with HCV therapy whereas non-injectors will show a more significant reduction in these markers, and will exhibit levels of immune activation that approach that seen in similarly studied healthy volunteers.This is based on observations that this group of investigators have made. They have shown that individuals who inject drugs have high level of immune activation in blood and tissue. Immune activation or chronic inflammation has been associated with accelerated aging, cardiovascular, renal and liver disease as well as CNS dysfunction. It remains unclear whether increased levels of immune activation are due to non-sterile injection of drugs, chronic infection with Hepatitis C, chronic opiate use, or perhaps combinations of all 3. To understand the potential contribution of infection with Hepatitis C the investigators will compare levels of immune activation pre- and post treatment with an all oral, one pill once daily, interferon sparing treatment of HCV in 2 groups of chronically HCV infected patients- one actively injecting with drugs and the other free of injection for at least 4 months. Immune activation comparisons will also include non-injecting healthy volunteers.
Primary Outcome
Marker of immune activation as measured by levels of soluble CD14. Note that the levels of sCD14 were only measured at baseline in the Healthy Volunteers group and therefore there are no data for weeks 4, 12, or 24 entered.
Interventions
- DRUG Harvoni (Fixed dose combination ledipasvir/sofosbuvir)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2016-11-15 |
| Est. Completion | 2016-11-15 |
| Phase | Phase 4 |
What the finished NCT02347345 record still lists
NCT02347345 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which Harvoni (Fixed dose combination ledipasvir/sofosbuvir) is the first listed.
NCT02347345 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02347345 about?
NCT02347345 is a clinical study titled "Immunologic Effects of HCV Therapy With HARVONI in HCV Genotype 1 Chronically Mono-infected Active and Former IDUs". The investigator's hypothesis is that active injectors will show a partial reduction in markers of immune activation with HCV therapy whereas non-injectors will show a more significant reduction in these markers, and will exhibit levels of immune activation that approach that seen in similarly studi...
What is the current status of trial NCT02347345?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 34 participants. The study started on 2016-11-15. Estimated completion is 2016-11-15.
What interventions are being tested in trial NCT02347345?
The interventions under investigation include: Harvoni (Fixed dose combination ledipasvir/sofosbuvir) (DRUG).
Who is sponsoring clinical trial NCT02347345?
This trial is sponsored by Rockefeller University, which has 117 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02347345's enrollment target sits among peer trials
34 1520th of 2000 higher than 473 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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