Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT03681184 · ClinicalTrials.gov registry record · Phase 3
A Study to Evaluate Lumasiran in Children and Adults With Primary Hyperoxaluria Type 1
A Phase 3 study, sponsored by Alnylam Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 39
- Enrollment target
NCT03681184: Completed Phase 3 study, sponsored by Alnylam Pharmaceuticals.
NCT03681184 is a Phase 3 study that has completed, run by Alnylam Pharmaceuticals. The registered enrollment target is 39 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03681184, a Phase 3 study, has completed, sponsored by Alnylam Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 39 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy and safety of lumasiran in children and adults with primary hyperoxaluria type 1 (PH1).
Primary Outcome
Percent change in 24-hour urinary oxalate excretion corrected for BSA was estimated by an average percent change from baseline across Months 3 through 6. Only valid urine samples without any non-protocol-related issues were included in the analysis. A negative change from Baseline indicates a favorable outcome.
Interventions
- DRUG Placebo
- DRUG Lumasiran
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2018-11-27 |
| Est. Completion | 2024-01-12 |
| Phase | Phase 3 |
What the finished NCT03681184 record still lists
NCT03681184 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT03681184 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03681184 about?
NCT03681184 is a clinical study titled "A Study to Evaluate Lumasiran in Children and Adults With Primary Hyperoxaluria Type 1". The purpose of this study is to evaluate the efficacy and safety of lumasiran in children and adults with primary hyperoxaluria type 1 (PH1).
What is the current status of trial NCT03681184?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 39 participants. The study started on 2018-11-27. Estimated completion is 2024-01-12.
What interventions are being tested in trial NCT03681184?
The interventions under investigation include: Placebo (DRUG), Lumasiran (DRUG).
Who is sponsoring clinical trial NCT03681184?
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 NCT03681184's enrollment target sits among peer trials
39 1898th of 2000 higher than 101 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03465592 · 39 participants · Phase 1
Trial of Nivolumab Following Partially Human Leukocyte Antigen (HLA) Mismatched BMT in Children & Adults With Sarcoma
- NCT03961776 · 39 participants
Monitoring Treatment Response With On-board DWI During Neo-adjuvant Chemo-radiation for Rectal Cancer Using Magnetic Resonance-guided-radiotherapy Systems
- NCT04050280 · 39 participants · Phase 2
CLAG-GO for Patients With Persistent, Relapsed or Refractory AML
- NCT04190862 · 39 participants · Phase 1
E-CEL UVEC as an Adjunct Cell Therapy for Treatment of Anal Fistulas
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI