Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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12 December 2020 |
Main ID: |
NCT01895361 |
Date of registration:
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03/07/2013 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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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 |
Scientific title:
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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 |
Date of first enrolment:
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July 2013 |
Target sample size:
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198 |
Recruitment status: |
Completed |
URL:
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https://clinicaltrials.gov/show/NCT01895361 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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Brazil
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Jamaica
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United States
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Key inclusion & exclusion criteria
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Key Inclusion Criteria:
- Sickle Cell Disease (HbSS, HbSC, HbSß°-thalassemia, or HbSß?-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
Age minimum:
16 Years
Age maximum:
65 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Sickle Cell Disease
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Intervention(s)
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Drug: Placebo
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Drug: SelG1
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Primary Outcome(s)
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Annual Rate of Sickle Cell-related Pain Crises (SCPC) - Per Standard Median
[Time Frame: One year]
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Annual Rate of Sickle Cell-related Pain Crises (SCPC) Per Hodges-Lehmann Median
[Time Frame: One year]
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Secondary Outcome(s)
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Time to First Sickle Cell-related Pain Crisis
[Time Frame: Up to one year]
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Annual Rate of Days Hospitalized (Key Secondary Endpoint) Per Hodges-Lehmann Median
[Time Frame: One year]
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Annual Rate of Acute Chest Syndrome Per Hodges-Lehmann Median
[Time Frame: One year]
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Annual Rate of Uncomplicated Sickle Cell-related Pain Crisis Per Hodges-Lehmann Median
[Time Frame: Up to one year]
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Patient Reported Outcome: Change From Baseline in Pain Severity/Pain Interference Domain From Brief Pain Inventory (BPI) Questionnaire
[Time Frame: Baseline, Day 15, Week 14, Week 26, Week 38, Week 52, and Week 58, up to 58 weeks]
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Time to Second Sickle Cell-related Pain Crisis
[Time Frame: Up to one year]
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Secondary ID(s)
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R44HL093893
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R01FD004805
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SelG1-00005
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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