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NCT03905694 · ClinicalTrials.gov registry record · Phase 3
A Study of Lumasiran in Infants and Young Children With Primary Hyperoxaluria Type 1
A Phase 3 study, sponsored by Alnylam Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 18
- Enrollment target
NCT03905694: Completed Phase 3 study, sponsored by Alnylam Pharmaceuticals.
NCT03905694 is a Phase 3 study that has completed, run by Alnylam Pharmaceuticals. The registered enrollment target is 18 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03905694, a Phase 3 study, has completed, sponsored by Alnylam Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 18 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of lumasiran in infants and young children with confirmed primary hyperoxaluria type 1 (PH1).
Primary Outcome
Percent change in spot urinary oxalate:creatinine ratio was estimated by an average percent change from baseline across Months 3 through 6. A negative change from Baseline indicates a favorable outcome.
Interventions
- DRUG Lumasiran
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 18 participants |
| Start Date | 2019-04-22 |
| Est. Completion | 2024-07-26 |
| Phase | Phase 3 |
What the finished NCT03905694 record still lists
NCT03905694 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 18 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Lumasiran is the first listed.
NCT03905694 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03905694 about?
NCT03905694 is a clinical study titled "A Study of Lumasiran in Infants and Young Children With Primary Hyperoxaluria Type 1". The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of lumasiran in infants and young children with confirmed primary hyperoxaluria type 1 (PH1).
What is the current status of trial NCT03905694?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 18 participants. The study started on 2019-04-22. Estimated completion is 2024-07-26.
What interventions are being tested in trial NCT03905694?
The interventions under investigation include: Lumasiran (DRUG).
Who is sponsoring clinical trial NCT03905694?
This trial is sponsored by Alnylam Pharmaceuticals, which has 49 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03905694's enrollment target sits among peer trials
18 1970th of 2000 higher than 30 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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