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NCT01419977 · ClinicalTrials.gov registry record · Phase 2

Treatment of Sickle Cell Patients Hospitalized in Pain Crisis With Prophylactic Dose Low-molecular-weight Heparin (LMWH) Versus Placebo

A Phase 2 study of Sickle Cell Disease and Vaso-occlusive Crisis, sponsored by Duke University.

Completed
Registry status
Phase 2
Development phase
34
Enrollment target
1
Study location

NCT01419977 is a Phase 2 study of Sickle Cell Disease and Vaso-occlusive Crisis that has completed, run by Duke University. The registered enrollment target is 34 participants, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT01419977, a Phase 2 study of Sickle Cell Disease and Vaso-occlusive Crisis, has completed, sponsored by Duke University.

COMPLETED
Registry status
Phase 2
Development phase
34 participants
Enrollment target
1
Study location

Study Summary

Sickle cell disease (SCD) is one of the most common inherited diseases worldwide and exhibits highest frequency in people of African descent. Patients with SCD currently have few treatment options, with hydroxyurea being the only medication approved to reduce the frequency of vaso-occlusive crisis (VOC) and prevent other SCD complications such as acute chest syndrome. Once patients develop VOC, hospitalizations aim to alleviate pain; no specific therapy is currently available to otherwise affect the course of the VOC. However, there has been increasing interest in the role of coagulation in the pathogenesis of SCD. The investigators hypothesize that low dose anticoagulant therapy, such as prophylactic dose low-molecular-weight heparin (LMWH), could be a novel way to ameliorate the vaso-occlusive process and thereby hasten the resolution of pain.

Interventions

  • DRUG Placebo
  • DRUG Dalteparin

Study Locations (1)

North Carolina

  • Duke University - Durham

Trial Details

FieldValue
Enrollment Target 34 participants
Start Date 2011-05
Est. Completion 2014-07
Phase Phase 2

Sponsor

Duke University

1,725 total trials

What the Registry Record Tells You About NCT01419977

The ClinicalTrials.gov registry entry for NCT01419977 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 34 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 (88% lower). The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Sickle Cell Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT01419977 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.

Frequently Asked Questions

What is clinical trial NCT01419977 about?

NCT01419977 is a clinical study titled "Treatment of Sickle Cell Patients Hospitalized in Pain Crisis With Prophylactic Dose Low-molecular-weight Heparin (LMWH) Versus Placebo". Sickle cell disease (SCD) is one of the most common inherited diseases worldwide and exhibits highest frequency in people of African descent. Patients with SCD currently have few treatment options, with hydroxyurea being the only medication approved to reduce the frequency of vaso-occlusive crisis (...

What is the current status of trial NCT01419977?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 34 participants. The study started on 2011-05. Estimated completion is 2014-07.

What conditions does trial NCT01419977 study?

This clinical trial studies the following conditions: Sickle Cell Disease, Vaso-occlusive Crisis.

What interventions are being tested in trial NCT01419977?

The interventions under investigation include: Placebo (DRUG), Dalteparin (DRUG).

Who is sponsoring clinical trial NCT01419977?

This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01419977 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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.