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NCT01077921 · ClinicalTrials.gov registry record · Phase 2
Study of Propranolol as Anti-Adhesive Therapy in Sickle Cell Disease (SCD)
A Phase 2 study of Sickle Cell Disease, sponsored by Laura M. De Castro, MD.
- Completed
- Registry status
- Phase 2
- Development phase
- 31
- Enrollment target
- 1
- Study location
NCT01077921: Completed Phase 2 study of Sickle Cell Disease, sponsored by Laura M. De Castro, MD.
NCT01077921 is a Phase 2 study of Sickle Cell Disease that has completed, run by Laura M. De Castro, MD. The registered enrollment target is 31 participants, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01077921, a Phase 2 study of Sickle Cell Disease, has completed, sponsored by Laura M. De Castro, MD.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 31 participants
- Enrollment target
- 1
- Study location
Study Summary
An open label, prospective, randomized cross-over phase II study in up to 60 sickle cell patients who are either homozygous for Hb S or have HbSB0 thalassemia. Initially, each patient will be treated for 6 weeks with placebo or a standard dose of propranolol (40 mg) every 12 hrs. This will be followed by a 2-week washout period after which, patients will receive the other treatment modality (placebo or propranolol). We Hypothesize that propranolol administered in vivo on a daily basis for 6 weeks (1) will decrease baseline adhesion to endothelial cells and will substantially abrogate epinephrine-stimulated adhesion to endothelial cells, as measured in vitro; (2) will improve biomarkers of endothelial activation and dysfunction; and (3) can be safely used in patients with SCD. Thus, the use of propranolol in SCD may represent a safe and effective means of anti-adhesive therapy in SCD. Study Objectives: Primary Objective: • To establish the safety and efficacy of long-term therapy with propranolol as an anti-adhesive therapy for SCD. Secondary Objective: • To evaluate changes in soluble markers of endothelial activation and dysfunction. Correlative Science Objective: • To determine whether response to propranolol therapy is associated with polymorphisms in genes encoding the proteins involved in the upregulation of Sickle Red Blood Cell (SS RBC) adhesion by epinephrine.
Primary Outcome
The stickiness of SS RBC will be evaluated by a well-established in vitro assay of adhesion of SS RBCs to cultured endothelial cells using a flow chamber. Overall change of adhesion from baseline to post intervention( Week 0 to 6 and week 8 to 14) in unstimulated cells (Sham treated) vs. Stimulated Red Blood Cells (Epi-treated) at 1 dyne/cm2
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Propranolol
Study Locations (1)
North Carolina
- Duke University Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2010-06 |
| Est. Completion | 2013-12 |
| Phase | Phase 2 |
What the finished NCT01077921 record still lists
NCT01077921 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Sickle Cell Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01077921 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT01077921 about?
NCT01077921 is a clinical study titled "Study of Propranolol as Anti-Adhesive Therapy in Sickle Cell Disease (SCD)". An open label, prospective, randomized cross-over phase II study in up to 60 sickle cell patients who are either homozygous for Hb S or have HbSB0 thalassemia. Initially, each patient will be treated for 6 weeks with placebo or a standard dose of propranolol (40 mg) every 12 hrs. This will be follow...
What is the current status of trial NCT01077921?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 31 participants. The study started on 2010-06. Estimated completion is 2013-12.
What conditions does trial NCT01077921 study?
This clinical trial studies the following conditions: Sickle Cell Disease.
What interventions are being tested in trial NCT01077921?
The interventions under investigation include: Placebo (DRUG), Propranolol (DRUG).
Who is sponsoring clinical trial NCT01077921?
This trial is sponsored by Laura M. De Castro, MD, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01077921 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01077921's enrollment target sits among peer trials
31 138th of 213 higher than 76 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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