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NCT01136941 · ClinicalTrials.gov registry record · Phase 1
Trial of Zileuton CR in Children and Adults With Sickle Cell Disease
A Phase 1 study, sponsored by Children's Hospital Medical Center, Cincinnati.
- Completed
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT01136941: Completed Phase 1 study, sponsored by Children's Hospital Medical Center, Cincinnati.
NCT01136941 is a Phase 1 study that has completed, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 9 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01136941, a Phase 1 study, has completed, sponsored by Children's Hospital Medical Center, Cincinnati.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
The purpose of this research study is to test the safety of Zileuton and see what effects (good and bad) it has on you, other children and adults with Sickle Cell Disease (SCD). The investigators also want to see how Zileuton is handled by your body at different doses. Zileuton is a drug that is approved by the Food and Drug Administration (FDA) for the treatment of asthma for people age 12 and older. The FDA has not approved Zileuton for the treatment of SCD, so it is being studied as an investigational drug for SCD through an application to the FDA. In asthma patients, Zileuton helps by reducing inflammation. This study will see if Zileuton helps to reduce inflammation associated with SCD.
Primary Outcome
The drug will be considered safe and tolerable if there is no grade-4 toxicity and no irreversible grade-3 toxicity upon de-escalation or discontinuation. The dose for the Part 2 portion of the trial will be the dose at which there was no DLT in 5 out of 6 at highest dose level below the maximally administered dose.
Interventions
- DRUG Zileuton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2010-09 |
| Est. Completion | 2013-04 |
| Phase | Phase 1 |
What the finished NCT01136941 record still lists
NCT01136941 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 1 intervention - of which Zileuton is the first listed.
NCT01136941 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01136941 about?
NCT01136941 is a clinical study titled "Trial of Zileuton CR in Children and Adults With Sickle Cell Disease". The purpose of this research study is to test the safety of Zileuton and see what effects (good and bad) it has on you, other children and adults with Sickle Cell Disease (SCD). The investigators also want to see how Zileuton is handled by your body at different doses. Zileuton is a drug that is ap...
What is the current status of trial NCT01136941?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2010-09. Estimated completion is 2013-04.
What interventions are being tested in trial NCT01136941?
The interventions under investigation include: Zileuton (DRUG).
Who is sponsoring clinical trial NCT01136941?
This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01136941's enrollment target sits among peer trials
9 1955th of 2000 higher than 42 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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