Trial record 1 of 1 for:    NCT01895361
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Study to Assess Safety and Impact of SelG1 With or Without Hydroxyurea Therapy in Sickle Cell Disease Patients With Pain Crises (SUSTAIN)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Selexys Pharmaceuticals Corporation
Sponsor:
Collaborators:
Food and Drug Administration (FDA)
Information provided by (Responsible Party):
Selexys Pharmaceuticals Corporation
ClinicalTrials.gov Identifier:
NCT01895361
First received: July 3, 2013
Last updated: October 7, 2014
Last verified: October 2014
  Purpose

The purpose of this study is to determine whether the investigational drug SelG1 when given to sickle cell disease patients either taking or not taking hydroxyurea is 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 will also be evaluated, as well as the safety of the drug and how long it stays in the blood stream.


Condition Intervention Phase
Sickle Cell Disease
Drug: SelG1
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Selexys Pharmaceuticals Corporation:

Primary Outcome Measures:
  • Rate of sickle cell-related pain crises [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of sickle cell-related pain crises by concomitant hydroxyurea use [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Time to first sickle cell-related pain crisis [ Time Frame: Up to one year ] [ Designated as safety issue: No ]
  • Time to second sickle cell-related pain crisis [ Time Frame: Up to one year ] [ Designated as safety issue: No ]
  • Number of hospitalization days per year [ Time Frame: Up to one year ] [ Designated as safety issue: No ]
  • Absolute change from baseline in hemoglobin [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Absolute change from baseline in lactate dehydrogenase [ Time Frame: One year ] [ Designated as safety issue: No ]

Estimated Enrollment: 174
Study Start Date: July 2013
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High-dose SelG1
IV Infusion, once every 4 weeks through Week 50
Drug: SelG1
Experimental: Low-dose SelG1
IV Infusion, once every 4 weeks through Week 50
Drug: SelG1
Placebo Comparator: Placebo
IV Infusion, once every 4 weeks through Week 50
Drug: Placebo

  Eligibility

Ages Eligible for Study:   16 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Sickle Cell Disease (HbSS, HbSC, HbSβ⁰-thalassemia, or HbSβ⁺-thalassemia)
  • If receiving hydroxyurea or erythropoietin, treatment must have been prescribed for at least 6 months, with the dose stable for at least 3 months
  • Between 2 and 10 sickle cell-related pain crises in the past 12 months

Key Exclusion Criteria:

  • On a chronic transfusion program or planning on exchange transfusion during the study
  • Hemoglobin <4.0 g/dL
  • Planned initiation, termination, or dose alteration of hydroxyurea during the study
  • Receiving chronic anticoagulation therapy (e.g. warfarin, heparin) other than aspirin
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01895361

Contacts
Contact: Jonathan Stocker, Ph.D. 855-735-3997 sustainstudy@selexys.com

  Show 53 Study Locations
Sponsors and Collaborators
Selexys Pharmaceuticals Corporation
Food and Drug Administration (FDA)
  More Information

No publications provided

Responsible Party: Selexys Pharmaceuticals Corporation
ClinicalTrials.gov Identifier: NCT01895361     History of Changes
Other Study ID Numbers: SelG1-00005, R44HL093893, R01FD004805
Study First Received: July 3, 2013
Last Updated: October 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Selexys Pharmaceuticals Corporation:
SelG1
P-selectin
monoclonal antibody
sickle cell disease
sickle cell anemia
sickle cell
pain crisis
pain crises
vasoocclusion
vaso-occlusion
priapism
hepatic sequestration
splenic sequestration
chest syndrome

Additional relevant MeSH terms:
Anemia, Sickle Cell
Anemia
Anemia, Hemolytic
Anemia, Hemolytic, Congenital
Genetic Diseases, Inborn
Hematologic Diseases
Hemoglobinopathies
Hydroxyurea
Antineoplastic Agents
Antisickling Agents
Enzyme Inhibitors
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014