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NCT02949830 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate Long-term Safety and Clinical Activity of Givosiran (ALN-AS1) in Patient With Acute Intermittent Porphyria (AIP)
A Phase 1 study of Acute Intermittent Porphyria, sponsored by Alnylam Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 16
- Enrollment target
- 5
- Study locations
NCT02949830: Completed Phase 1 study of Acute Intermittent Porphyria, sponsored by Alnylam Pharmaceuticals.
NCT02949830 is a Phase 1 study of Acute Intermittent Porphyria that has completed, run by Alnylam Pharmaceuticals. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02949830, a Phase 1 study of Acute Intermittent Porphyria, has completed, sponsored by Alnylam Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 16 participants
- Enrollment target
- 5
- Study locations
Study Summary
The purpose of this study is to determine the long-term safety, tolerability and pharmacokinetics of givosiran (ALN-AS1) in AIP patients who completed study ALN-AS1-001 (NCT02452372).
Primary Outcome
An AE is any untoward medical occurrence in a participant or clinical investigational patient administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Conditions Studied
Interventions
- DRUG Givosiran
Study Locations (5)
Other
- Clinical Trial Site - Stockholm
- Clinical Trial Site - London
California
- Clinical Trial Site - San Francisco
New York
- Clinical Trial Site - New York
Texas
- Clinical Trial Site - Galveston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2016-10 |
| Est. Completion | 2021-11-05 |
| Phase | Phase 1 |
What the finished NCT02949830 record still lists
NCT02949830 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).
The record links to 1 condition, with Acute Intermittent Porphyria appearing as the primary indexed condition, and to 1 intervention - of which Givosiran is the first listed.
NCT02949830 lists 5 locations in 4 states (Other, California, New York).
Frequently Asked Questions
What is clinical trial NCT02949830 about?
NCT02949830 is a clinical study titled "A Study to Evaluate Long-term Safety and Clinical Activity of Givosiran (ALN-AS1) in Patient With Acute Intermittent Porphyria (AIP)". The purpose of this study is to determine the long-term safety, tolerability and pharmacokinetics of givosiran (ALN-AS1) in AIP patients who completed study ALN-AS1-001 (NCT02452372).
What is the current status of trial NCT02949830?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2016-10. Estimated completion is 2021-11-05.
What conditions does trial NCT02949830 study?
This clinical trial studies the following conditions: Acute Intermittent Porphyria.
What interventions are being tested in trial NCT02949830?
The interventions under investigation include: Givosiran (DRUG).
Who is sponsoring clinical trial NCT02949830?
This trial is sponsored by Alnylam Pharmaceuticals, which has 49 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02949830 being conducted?
This trial has 5 study locations across California, New York, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02949830's enrollment target sits among peer trials
16 1786th of 2000 higher than 203 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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