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NCT00122980 · ClinicalTrials.gov registry record · Phase 3

Stroke With Transfusions Changing to Hydroxyurea

A Phase 3 study, sponsored by St. Jude Children's Research Hospital.

Terminated
Registry status
Phase 3
Development phase
134
Enrollment target

NCT00122980: Clinical Trial Phase 3 study, sponsored by St. Jude Children's Research Hospital.

NCT00122980 is a Phase 3 study that was terminated before completion, run by St. Jude Children's Research Hospital. The registered enrollment target is 134 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00122980, a Phase 3 study, was terminated before completion, sponsored by St. Jude Children's Research Hospital.

TERMINATED
Registry status
Phase 3
Development phase
134 participants
Enrollment target

Study Summary

The purpose of this study is to compare standard therapy (transfusions and chelation) with alternative therapy (hydroxyurea and phlebotomy) for the prevention of secondary stroke and management of iron overload in children with sickle cell anemia (SCA).

Primary Outcome

Secondary stroke is the first component of the composite primary endpoint and considers the number of participants with recurrent secondary stroke events during 30 months of treatment. Stroke was defined as any clinical event with brain injury due to vascular disease. All neurological events underwent formal stroke adjudication.

Interventions

  • DRUG Hydroxyurea
  • PROCEDURE Phlebotomy
  • PROCEDURE Red Cell Transfusions
  • PROCEDURE Iron Chelation

Trial Details

FieldValue
Enrollment Target 134 participants
Start Date 2006-10
Est. Completion 2010-12
Phase Phase 3

Why NCT00122980 stopped before completion

NCT00122980 is an interventional study that assigns participants to a tested intervention. The registered 134 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower).

The record links to 0 conditions, and to 4 interventions - of which Hydroxyurea is the first listed.

NCT00122980 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00122980 about?

NCT00122980 is a clinical study titled "Stroke With Transfusions Changing to Hydroxyurea". The purpose of this study is to compare standard therapy (transfusions and chelation) with alternative therapy (hydroxyurea and phlebotomy) for the prevention of secondary stroke and management of iron overload in children with sickle cell anemia (SCA).

What is the current status of trial NCT00122980?

This trial is currently terminated. It is a Phase 3 study. The enrollment target is 134 participants. The study started on 2006-10. Estimated completion is 2010-12.

What interventions are being tested in trial NCT00122980?

The interventions under investigation include: Hydroxyurea (DRUG), Phlebotomy (PROCEDURE), Red Cell Transfusions (PROCEDURE), Iron Chelation (PROCEDURE).

Who is sponsoring clinical trial NCT00122980?

This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00122980's enrollment target sits among peer trials

134 1585th of 2000 higher than 413 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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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Source: ClinicalTrials.gov NCT00122980, the US trial registry maintained by the National Library of Medicine. NCT00122980 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.