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NCT04152200 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate Lumasiran in Patients With Advanced Primary Hyperoxaluria Type 1
A Phase 3 study, sponsored by Alnylam Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 21
- Enrollment target
NCT04152200: Completed Phase 3 study, sponsored by Alnylam Pharmaceuticals.
NCT04152200 is a Phase 3 study that has completed, run by Alnylam Pharmaceuticals. The registered enrollment target is 21 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04152200, a Phase 3 study, has completed, sponsored by Alnylam Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 21 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of lumasiran in patients with Advanced Primary Hyperoxaluria Type 1 (PH1).
Primary Outcome
Percent change in plasma oxalate (umol/L) was estimated by an average percent change from baseline across Months 3 through 6. A negative change from Baseline indicates a favorable outcome. For Cohort A, the baseline was defined as the mean of all plasma oxalate level values collected prior to the first dose of lumasiran.
Interventions
- DRUG Lumasiran
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2020-01-21 |
| Est. Completion | 2025-06-23 |
| Phase | Phase 3 |
What the finished NCT04152200 record still lists
NCT04152200 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 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Lumasiran is the first listed.
NCT04152200 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04152200 about?
NCT04152200 is a clinical study titled "A Study to Evaluate Lumasiran in Patients With Advanced Primary Hyperoxaluria Type 1". The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PD) of lumasiran in patients with Advanced Primary Hyperoxaluria Type 1 (PH1).
What is the current status of trial NCT04152200?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 21 participants. The study started on 2020-01-21. Estimated completion is 2025-06-23.
What interventions are being tested in trial NCT04152200?
The interventions under investigation include: Lumasiran (DRUG).
Who is sponsoring clinical trial NCT04152200?
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 NCT04152200's enrollment target sits among peer trials
21 1953rd of 2000 higher than 45 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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