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NCT00049764 · ClinicalTrials.gov registry record · Phase 3

Investigation of the Efficacy and Safety of Drotrecogin Alfa (Activated) in Pediatric Severe Sepsis

A Phase 3 study, sponsored by Eli Lilly and Company.

Completed
Registry status
Phase 3
Development phase
474
Enrollment target

NCT00049764: Completed Phase 3 study, sponsored by Eli Lilly and Company.

NCT00049764 is a Phase 3 study that has completed, run by Eli Lilly and Company. The registered enrollment target is 474 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (39% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00049764, a Phase 3 study, has completed, sponsored by Eli Lilly and Company.

COMPLETED
Registry status
Phase 3
Development phase
474 participants
Enrollment target

Study Summary

The purposes of this study are to determine: 1. Whether drotrecogin alfa (activated) helps children with severe sepsis survive their condition more often or recover faster than children who do not receive drotrecogin alfa (activated). 2. Whether drotrecogin alfa (activated) minimizes long term disabilities associated with severe sepsis. 3. The side effects that might be associated with drotrecogin alfa (activated) administration to children with severe sepsis.

Interventions

  • DRUG Placebo
  • DRUG Drotrecogin alfa (activated)

Trial Details

FieldValue
Enrollment Target 474 participants
Start Date 2002-11
Est. Completion 2005-04
Phase Phase 3
Eli Lilly and Company

1,341 total trials

What the finished NCT00049764 record still lists

NCT00049764 is an interventional study that assigns participants to a tested intervention. The registered 474 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 (39% lower).

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

NCT00049764 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00049764 about?

NCT00049764 is a clinical study titled "Investigation of the Efficacy and Safety of Drotrecogin Alfa (Activated) in Pediatric Severe Sepsis". The purposes of this study are to determine: 1. Whether drotrecogin alfa (activated) helps children with severe sepsis survive their condition more often or recover faster than children who do not receive drotrecogin alfa (activated). 2. Whether drotrecogin alfa (activated) minimizes long term disa...

What is the current status of trial NCT00049764?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 474 participants. The study started on 2002-11. Estimated completion is 2005-04.

What interventions are being tested in trial NCT00049764?

The interventions under investigation include: Placebo (DRUG), Drotrecogin alfa (activated) (DRUG).

Who is sponsoring clinical trial NCT00049764?

This trial is sponsored by Eli Lilly and Company, which has 1,341 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00049764's enrollment target sits among peer trials

474 810th of 2000 higher than 1,190 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 NCT00049764, the US trial registry maintained by the National Library of Medicine. NCT00049764 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.