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NCT01085201 · ClinicalTrials.gov registry record · Phase 1
Adenosine 2A Agonist Lexiscan in Children and Adults With Sickle Cell Disease
A Phase 1 study of Sickle Cell Disease, sponsored by Dana-Farber Cancer Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 39
- Enrollment target
- 7
- Study locations
NCT01085201: Completed Phase 1 study of Sickle Cell Disease, sponsored by Dana-Farber Cancer Institute.
NCT01085201 is a Phase 1 study of Sickle Cell Disease that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 39 participants, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (87% lower). The trial reports 7 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01085201, a Phase 1 study of Sickle Cell Disease, has completed, sponsored by Dana-Farber Cancer Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 39 participants
- Enrollment target
- 7
- Study locations
Study Summary
Sickle cell disease (SCD) is an inherited blood disorder that causes the red blood cells to change their shape from a round shape to a half-moon/crescent or sickled shape. People who have SCD have a different type of protein that carries oxygen in their blood (hemoglobin) then people without SCD. This different type of hemoglobin makes the red blood cells change into a crescent shape under certain conditions. Sickle-shaped cells are a problem because they often get stuck in blood vessels blocking the flow of blood, and cause inflammation and injury to the important areas in the body. Lexiscan is drug that may prevent this inflammation and injury caused by the sickle shaped cells. This drug is approved by the FDA to be used as a fast infusion during a heart stress test in people who are unable to exercise enough to put stress on their heart by making it beat faster. Lexiscan has never been studied in patients with SCD and has never been given as a long infusion.
Primary Outcome
Per protocol, Lexiscan was considered "safe" if well tolerated based on number of DLTs reported. Stage 1 of the study was a 3+3 dose escalation study. Three doses were tested: 0.24 mcg/kg/hr (dose level 0), 0.6 mcg/kg/hr (dose level 1), and 1.44 mcg/kg/hr (dose level 2). Dose escalation continued until 6 participants were treated at the maximum planned dose (dose level 2). We studied a total of 15 patients in Stage 1. In Stages 2 and 3, if at least 2/3 participants tolerated the dose, an additio
Conditions Studied
Interventions
- DRUG Lexiscan
Study Locations (7)
Massachusetts
- Brigham and Women's Hospital - Boston
- Childrens Hospital Boston - Boston
- Dana-Farber Cancer Institute - Boston
District of Columbia
- Howard University Hospital - Washington D.C.
Maryland
- Johns Hopkins University - Baltimore
Missouri
- Washington University - St Louis
Wisconsin
- Blood Center of Wisconsin - Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2010-04 |
| Est. Completion | 2013-03 |
| Phase | Phase 1 |
What the finished NCT01085201 record still lists
NCT01085201 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (87% lower).
The record links to 1 condition, with Sickle Cell Disease appearing as the primary indexed condition, and to 1 intervention - of which Lexiscan is the first listed.
NCT01085201 lists 7 locations in 5 states (Massachusetts, District of Columbia, Maryland).
Frequently Asked Questions
What is clinical trial NCT01085201 about?
NCT01085201 is a clinical study titled "Adenosine 2A Agonist Lexiscan in Children and Adults With Sickle Cell Disease". Sickle cell disease (SCD) is an inherited blood disorder that causes the red blood cells to change their shape from a round shape to a half-moon/crescent or sickled shape. People who have SCD have a different type of protein that carries oxygen in their blood (hemoglobin) then people without SCD. Th...
What is the current status of trial NCT01085201?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 39 participants. The study started on 2010-04. Estimated completion is 2013-03.
What conditions does trial NCT01085201 study?
This clinical trial studies the following conditions: Sickle Cell Disease.
What interventions are being tested in trial NCT01085201?
The interventions under investigation include: Lexiscan (DRUG).
Who is sponsoring clinical trial NCT01085201?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01085201 being conducted?
This trial has 7 study locations across District of Columbia, Maryland, Massachusetts, Missouri, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01085201's enrollment target sits among peer trials
39 129th of 213 higher than 85 of 213 other Sickle Cell Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sickle Cell Disease 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.
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