Study to Assess Safety and Impact of SelG1 With or Without Hydroxyurea Therapy in Sickle Cell Disease Patients With Pain Crises

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Reprixys Pharmaceutical Corporation
Study ID
NCT01895361
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
16 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • SelG1 — DRUG
  • Placebo — DRUG

Study Details

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)

Key Dates

Start date
Jul 31, 2013
Status verified
Jan 2020
Primary completion
Mar 31, 2016
Completion
Mar 31, 2016

Study Design

Enrollment
198 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: High-dose SelG1 (Selg1 5.0 mg/kg)
    IV Infusion, once every 4 weeks through Week 50
  • Experimental: Low-dose SelG1 (Selg1 2.5 mg/kg)
    IV Infusion, once every 4 weeks through Week 50
  • Placebo Comparator: Placebo
    IV Infusion, once every 4 weeks through Week 50

Primary Outcome Measure

Annual Rate of Sickle Cell-related Pain Crises (SCPC) Per Hodges-Lehmann Median [ Time Frame: One year ]

Locations (49)

FacilityCityStateZIPSite coordinators
-BirminghamAlabama--
-MobileAlabama--
-Little RockArkansas--
-Los AngelesCalifornia--
-OaklandCalifornia--
-OrangeCalifornia--
-SacramentoCalifornia--
-AuroraColorado--
-New HavenConnecticut--
-Washington D.C.District of Columbia--
-Daytona BeachFlorida--
-JacksonvilleFlorida--
-MiamiFlorida--
-OrlandoFlorida--
-TampaFlorida--
-AtlantaGeorgia--
-AugustaGeorgia--
-ChicagoIllinois--
-PeoriaIllinois--
-IndianapolisIndiana--
-LouisvilleKentucky--
-Baton RougeLouisiana--
-New OrleansLouisiana--
-BaltimoreMaryland--
-BethesdaMaryland--
-BostonMassachusetts--
-DetroitMichigan--
-JacksonMississippi--
-Kansas CityMissouri--
-Las VegasNevada--
-New BrunswickNew Jersey--
-NewarkNew Jersey--
-BrooklynNew York--
-New Hyde ParkNew York--
-The BronxNew York--
-Chapel HillNorth Carolina--
-DurhamNorth Carolina--
-GreenvilleNorth Carolina--
-ClevelandOhio--
-ColumbusOhio--
-Oklahoma CityOklahoma--
-PhiladelphiaPennsylvania--
-PittsburghPennsylvania--
-CharlestonSouth Carolina--
-SumterSouth Carolina--
-Fort WorthTexas--
-HoustonTexas--
-NorfolkVirginia--
-RichmondVirginia--

Find similar trials in Birmingham, AL

By condition
Sickle cell disease

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