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NCT00867932 · ClinicalTrials.gov registry record · Phase 4
Eculizumab Pharmacokinetics/Pharmacodynamics Study in Pediatric/Adolescent Paroxysmal Nocturnal Hemoglobinuria (PNH)
A Phase 4 study, sponsored by Alexion Pharmaceuticals.
- Completed
- Registry status
- Phase 4
- Development phase
- 7
- Enrollment target
NCT00867932: Completed Phase 4 study, sponsored by Alexion Pharmaceuticals.
NCT00867932 is a Phase 4 study that has completed, run by Alexion Pharmaceuticals. The registered enrollment target is 7 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00867932, a Phase 4 study, has completed, sponsored by Alexion Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 7 participants
- Enrollment target
Study Summary
The primary objective of this study was to evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) parameter estimates of eculizumab to confirm the dose regimens for pediatric and adolescent participants with PNH.
Primary Outcome
Serum concentrations of eculizumab were measured by using a validated enzyme-linked immunosorbent assay (ELISA) method developed at Alexion Pharmaceuticals Bioanalytical Laboratory. The range of the analytical assay was 10 to 600 microgram per milliliter (μg/mL). Peak concentrations were not measured at the early termination (ET) visit.
Interventions
- DRUG Eculizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2009-10-02 |
| Est. Completion | 2011-05-12 |
| Phase | Phase 4 |
What the finished NCT00867932 record still lists
NCT00867932 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 7 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Eculizumab is the first listed.
NCT00867932 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00867932 about?
NCT00867932 is a clinical study titled "Eculizumab Pharmacokinetics/Pharmacodynamics Study in Pediatric/Adolescent Paroxysmal Nocturnal Hemoglobinuria (PNH)". The primary objective of this study was to evaluate the pharmacokinetic (PK) and pharmacodynamic (PD) parameter estimates of eculizumab to confirm the dose regimens for pediatric and adolescent participants with PNH.
What is the current status of trial NCT00867932?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 7 participants. The study started on 2009-10-02. Estimated completion is 2011-05-12.
What interventions are being tested in trial NCT00867932?
The interventions under investigation include: Eculizumab (DRUG).
Who is sponsoring clinical trial NCT00867932?
This trial is sponsored by Alexion Pharmaceuticals, which has 162 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00867932's enrollment target sits among peer trials
7 1981st of 2000 higher than 18 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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