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NCT00841100 · ClinicalTrials.gov registry record · Phase 2
Kuvan Therapy in Phenylketonuria (PKU): The Effect of Blood Phenylalanine Concentration on Kuvan Response
A Phase 2 study, sponsored by University of Miami.
- Completed
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
NCT00841100: Completed Phase 2 study, sponsored by University of Miami.
NCT00841100 is a Phase 2 study that has completed, run by University of Miami. The registered enrollment target is 21 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00841100, a Phase 2 study, has completed, sponsored by University of Miami.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 21 participants
- Enrollment target
Study Summary
The investigators will investigate the effect of blood phenylalanine on Kuvan responsiveness in the same patients with PKU when their blood phenylalanine concentrations are altered by diet. Lowering blood phenylalanine concentrations in Kuvan non-responsive patients with PKU will increase the frequency of Kuvan responsiveness.
Primary Outcome
Percent change in phenylalanine in (uM) on Kuvan Response evaluated via fasting morning blood serum. A decrease of 30% or greater indicates positive response on Kuvan.
Interventions
- OTHER Diet
- DRUG Kuvan
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2008-12 |
| Est. Completion | 2011-07-19 |
| Phase | Phase 2 |
What the finished NCT00841100 record still lists
NCT00841100 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 21 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (84% lower).
The record links to 0 conditions, and to 2 interventions - of which Diet is the first listed.
NCT00841100 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00841100 about?
NCT00841100 is a clinical study titled "Kuvan Therapy in Phenylketonuria (PKU): The Effect of Blood Phenylalanine Concentration on Kuvan Response". The investigators will investigate the effect of blood phenylalanine on Kuvan responsiveness in the same patients with PKU when their blood phenylalanine concentrations are altered by diet. Lowering blood phenylalanine concentrations in Kuvan non-responsive patients with PKU will increase the frequ...
What is the current status of trial NCT00841100?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2008-12. Estimated completion is 2011-07-19.
What interventions are being tested in trial NCT00841100?
The interventions under investigation include: Diet (OTHER), Kuvan (DRUG).
Who is sponsoring clinical trial NCT00841100?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00841100's enrollment target sits among peer trials
21 1794th of 2000 higher than 196 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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