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NCT02605304 · ClinicalTrials.gov registry record · Phase 2
12 Weeks of Ledipasvir (LDV)/Sofosbuvir (SOF) With Weight-based Ribavirin vs. 24 Weeks of LDV/SOF
A Phase 2 study, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.
- Terminated
- Registry status
- Phase 2
- Development phase
- 7
- Enrollment target
NCT02605304: Clinical Trial Phase 2 study, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.
NCT02605304 is a Phase 2 study that was terminated before completion, run by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections. The registered enrollment target is 7 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02605304, a Phase 2 study, was terminated before completion, sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 7 participants
- Enrollment target
Study Summary
People who are infected with Hepatitis C Virus (HCV) have a great chance of being cured of the infection when they are treated with sofosbuvir. However, in some instances, treatment with sofosbuvir-containing therapy does not work. It is not known if people respond to retreatment with sofosbuvir, after it did not work the first time. There is an important need to understand retreatment options in those instances. This clinical trial was done to study the response to two different regimens, ledipasvir/sofosbuvir and ledipasvir/sofosbuvir with ribavirin, and to see if they are safe and well-tolerated in HCV-infected persons whose previous treatment with sofosbuvir had failed.
Primary Outcome
SVR12 was defined as HCV RNA below the LLOQ of the assay (either target detected \[TD\] or target not detected \[TND\]) at 12 weeks after treatment discontinuation. The sample within the visit window, closest to the targeted time was used. If there was no HCV RNA sample within visit window, then the participant was considered not to have achieved SVR12, unless there were preceding and subsequent HCV RNA measurements that were both \<LLOQ (either TD or TND). HCV RNA testing was conducted at a cen
Interventions
- DRUG Ribavirin
- DRUG Ledipasvir/sofosbuvir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2016-02-17 |
| Est. Completion | 2017-03-20 |
| Phase | Phase 2 |
Why NCT02605304 stopped before completion
NCT02605304 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Ribavirin is the first listed.
NCT02605304 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02605304 about?
NCT02605304 is a clinical study titled "12 Weeks of Ledipasvir (LDV)/Sofosbuvir (SOF) With Weight-based Ribavirin vs. 24 Weeks of LDV/SOF". People who are infected with Hepatitis C Virus (HCV) have a great chance of being cured of the infection when they are treated with sofosbuvir. However, in some instances, treatment with sofosbuvir-containing therapy does not work. It is not known if people respond to retreatment with sofosbuvir, af...
What is the current status of trial NCT02605304?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 7 participants. The study started on 2016-02-17. Estimated completion is 2017-03-20.
What interventions are being tested in trial NCT02605304?
The interventions under investigation include: Ribavirin (DRUG), Ledipasvir/sofosbuvir (DRUG).
Who is sponsoring clinical trial NCT02605304?
This trial is sponsored by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections, which has 45 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02605304's enrollment target sits among peer trials
7 1996th of 2000 higher than 5 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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