NL-OMON52183
Completed
Not Applicable
A 2-Part, Phase 1, Multicenter, Single Dose, Open-Label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CSL889 in Adult Patients with Sickle Cell Disease - CSL889_1001 (2102/0113)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- CSL Behring LLC
- Enrollment
- 5
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
Trial is onging in other countries
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosis of SCD as documented in the subject's medical record
- •Aged 18 to 60 years, inclusive
- •Stable SCD for at least 30 days before Day 1\. Stable SCD is defined as the
- •subject being at his or her medical baseline, with no evidence of worsening of
- •disease over the last 30 days (including VOC, recent major surgery,
- •hospitalization, serious infection, significant bleeding, cerebrovascular
- •accident, seizures, or IV opioids)(Part A)
- •Uncomplicated VOC requiring parenteral opioid treatment and admission to
- •hospital for management
- •Uncomplicated VOC is defined as sickle cell pain without the following
Exclusion Criteria
- •History of primary hemorrhagic stroke
- •History or evidence of inherited bleeding diathesis or significant
- •coagulopathy at risk for bleeding
- •Hospitalization for vaso\-occlusive crisis (VOC) or treated with parenteral
- •pain medications in other medical settings such as the emergency department or
- •day hospital for VOC during the past 30 days before Day 1
- •Blood transfusion within the 90 days before Day 1, or expecting blood
- •transfusion during the study
- •Weight \>110 kg (242 lbs)
- •Surgery within 30 days before Day 1 or any preplanned surgeries during the
Outcomes
Primary Outcomes
Not specified
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