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NCT01895361 · ClinicalTrials.gov registry record · Phase 2
Study to Assess Safety and Impact of SelG1 With or Without Hydroxyurea Therapy in Sickle Cell Disease Patients With Pain Crises
A Phase 2 study of Sickle Cell Disease, sponsored by Reprixys Pharmaceutical Corporation.
- Completed
- Registry status
- Phase 2
- Development phase
- 198
- Enrollment target
- 20
- Study locations
NCT01895361: Completed Phase 2 study of Sickle Cell Disease, sponsored by Reprixys Pharmaceutical Corporation.
NCT01895361 is a Phase 2 study of Sickle Cell Disease that has completed, run by Reprixys Pharmaceutical Corporation. The registered enrollment target is 198 participants, below the 292-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (32% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01895361, a Phase 2 study of Sickle Cell Disease, has completed, sponsored by Reprixys Pharmaceutical Corporation.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 198 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study was to determine whether the investigational drug SelG1 when given to sickle cell disease patients either taking or not taking hydroxyurea was effective in preventing or reducing the occurrence of pain crises. SelG1 prevents various cells in the bloodstream from sticking together. By stopping these cell-cell interactions, SelG1 may prevent small blood vessels from becoming blocked and therefore reduce the occurrence and severity of pain crises. Other effects of SelG1 was evaluated, as well as the safety of the drug and how long it stayed in the blood stream. Funding Source - FDA Office of Orphan Products Development (OOPD)
Primary Outcome
An SCPC is defined as an acute episode of pain with no other medically determined cause than a vasoocclusive event that requires a medical facility visit and treatment with oral or parenteral narcotics, or parenteral non-steroidal anti-inflammatory drugs. The annual rate of SCPC is defined as the total number of pain crises for a patient occurring from the date of randomization to the end date multiplied by 365 divided by the number of days during that same time period. End date is defined as th
Conditions Studied
Interventions
- DRUG Placebo
- DRUG SelG1
Study Locations (20)
Florida
- - Daytona Beach
- - Jacksonville
- - Miami
- - Orlando
- - Tampa
California
- - Los Angeles
- - Oakland
- - Orange
- - Sacramento
Alabama
- - Birmingham
- - Mobile
Georgia
- - Atlanta
- - Augusta
Illinois
- - Chicago
- - Peoria
Arkansas
- - Little Rock
Colorado
- - Aurora
Connecticut
- - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 198 participants |
| Start Date | 2013-07 |
| Est. Completion | 2016-03 |
| Phase | Phase 2 |
What the finished NCT01895361 record still lists
NCT01895361 is an interventional study that assigns participants to a tested intervention. The registered 198 participants enrollment target is mid-sized for trials with a published cap, below the 292-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (32% lower).
The record links to 1 condition, with Sickle Cell Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01895361 names 20 study sites across 10 states, led by Florida, California, Alabama.
Frequently Asked Questions
What is clinical trial NCT01895361 about?
NCT01895361 is a clinical study titled "Study to Assess Safety and Impact of SelG1 With or Without Hydroxyurea Therapy in Sickle Cell Disease Patients With Pain Crises". The purpose of this study was to determine whether the investigational drug SelG1 when given to sickle cell disease patients either taking or not taking hydroxyurea was effective in preventing or reducing the occurrence of pain crises. SelG1 prevents various cells in the bloodstream from sticking to...
What is the current status of trial NCT01895361?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 198 participants. The study started on 2013-07. Estimated completion is 2016-03.
What conditions does trial NCT01895361 study?
This clinical trial studies the following conditions: Sickle Cell Disease.
What interventions are being tested in trial NCT01895361?
The interventions under investigation include: Placebo (DRUG), SelG1 (DRUG).
Who is sponsoring clinical trial NCT01895361?
This trial is sponsored by Reprixys Pharmaceutical Corporation, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01895361 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01895361's enrollment target sits among peer trials
198 36th of 213 higher than 178 of 213 other Sickle Cell Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Sickle Cell Disease 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.
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