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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 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.

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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.

Conditions Studied

Sickle Cell Disease

Interventions

  • DRUG Placebo
  • DRUG Propranolol

Study Locations (1)

North Carolina

  • Duke University Medical Center - Durham

Trial Details

FieldValue
Enrollment Target 31 participants
Start Date 2010-06
Est. Completion 2013-12
Phase Phase 2

Sponsor

Laura M. De Castro, MD

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01077921

The ClinicalTrials.gov registry entry for NCT01077921 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 31 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (89% lower). The listed sponsor is Laura M. De Castro, MD, which has 1 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.