Clinical trial
Phase 3 Study to Evaluate the Efficacy & Safety of Self-Administered Injections…
NCT01889862 · BioMarin Pharmaceutical, Industry · Completed
Key facts
| NCT number | NCT01889862 |
|---|---|
| Title | Phase 3 Study to Evaluate the Efficacy & Safety of Self-Administered Injections of BMN165 by Adults With PKU |
| Official title | A Four-Part, Phase 3, Randomized, Double-Blind, Placebo- Controlled, Four-Arm, Discontinuation Study to Evaluate the Efficacy and Safety of Subcutaneous Injections of BMN 165 Self-Administered by Adults With Phenylketonuria (PKU) |
| Acronym | Prism-2 |
| Lead sponsor | BioMarin Pharmaceutical, Industry |
| Status | Completed |
| Phase | Phase 3 |
| Study type | Interventional |
| Conditions | Phenylketonuria (PKU) |
| Intervention type | Drug |
| Interventions | BMN165 20mg/day, BMN165 40mg/day, Placebo |
| Enrollment | 215 |
| Start date | Jul 29, 2013 |
| Primary completion | Jan 13, 2016 |
| Completion | Feb 5, 2019 |
| First posted | Jul 1, 2013 |
| Last update posted | May 21, 2021 |
| Countries | United States |
At a glance
- 10–99 Study sites
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About ClinicalTrials.gov studies
ClinicalTrials.gov is the U.S. National Library of Medicine's registry of clinical studies conducted around the world. Contact and investigator details are not shown here.
Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: