Clinical trial
Study to Assess Safety and Impact of SelG1 With or Without Hydroxyurea Therapy…
NCT01895361 · Reprixys Pharmaceutical Corporation, Industry · Completed
Key facts
| NCT number | NCT01895361 |
|---|---|
| Title | Study to Assess Safety and Impact of SelG1 With or Without Hydroxyurea Therapy in Sickle Cell Disease Patients With Pain Crises |
| Official title | A Phase II, Multicenter, Randomized, Placebo-Controlled, Double-Blind, 12-Month Study to Assess Safety and Efficacy of SelG1 With or Without Hydroxyurea Therapy in Sickle Cell Disease Patients With Sickle Cell-Related Pain Crises |
| Acronym | SUSTAIN |
| Lead sponsor | Reprixys Pharmaceutical Corporation, Industry |
| Collaborators | National Heart, Lung, and Blood Institute (NHLBI) NIH Food and Drug Administration (FDA) U.S. Fed |
| Status | Completed |
| Phase | Phase 2 |
| Study type | Interventional |
| Conditions | Sickle Cell Disease |
| Intervention type | Drug |
| Interventions | SelG1, Placebo |
| Enrollment | 198 |
| Start date | Jul 1, 2013 |
| Primary completion | Mar 1, 2016 |
| Completion | Mar 1, 2016 |
| First posted | Jul 10, 2013 |
| Last update posted | Jan 31, 2020 |
| Countries | Brazil, Jamaica, United States |
At a glance
- 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: