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NCT00538785 · ClinicalTrials.gov registry record · Phase 2

A Study to Evaluate MEDI-524 In Children With Hemodynamically Significant Congenital Heart Disease

A Phase 2 study, sponsored by MedImmune.

Completed
Registry status
Phase 2
Development phase
1,236
Enrollment target

NCT00538785: Completed Phase 2 study, sponsored by MedImmune.

NCT00538785 is a Phase 2 study that has completed, run by MedImmune. The registered enrollment target is 1,236 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (829% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00538785, a Phase 2 study, has completed, sponsored by MedImmune.

COMPLETED
Registry status
Phase 2
Development phase
1,236 participants
Enrollment target

Study Summary

The primary goal was to describe the safety of the investigational product when given monthly to prevent serious respiratory infection among children with significant heart disease.

Primary Outcome

Adverse events were summarized by system organ class (SOC) and preferred term (using MedDRA Version 11.1) overall.

Interventions

  • BIOLOGICAL Palivizumab
  • BIOLOGICAL Motavizumab

Trial Details

FieldValue
Enrollment Target 1,236 participants
Start Date 2005-10
Est. Completion 2008-06
Phase Phase 2
MedImmune

210 total trials

What the finished NCT00538785 record still lists

NCT00538785 is an interventional study that assigns participants to a tested intervention. Its 1,236 participants enrollment target places it among the larger protocols in the corpus, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (829% higher).

The record links to 0 conditions, and to 2 interventions - of which Palivizumab is the first listed.

NCT00538785 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00538785 about?

NCT00538785 is a clinical study titled "A Study to Evaluate MEDI-524 In Children With Hemodynamically Significant Congenital Heart Disease". The primary goal was to describe the safety of the investigational product when given monthly to prevent serious respiratory infection among children with significant heart disease.

What is the current status of trial NCT00538785?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 1,236 participants. The study started on 2005-10. Estimated completion is 2008-06.

What interventions are being tested in trial NCT00538785?

The interventions under investigation include: Palivizumab (BIOLOGICAL), Motavizumab (BIOLOGICAL).

Who is sponsoring clinical trial NCT00538785?

This trial is sponsored by MedImmune, which has 210 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00538785's enrollment target sits among peer trials

1,236 16th of 2000 higher than 1,985 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT00538785, the US trial registry maintained by the National Library of Medicine. NCT00538785 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.