CTRI/2022/06/043467Not yet recruitingPhase 4
Prospective, observational study in Sickle Cell Diseasepatients on crizanlizumab treatment in Middle Eastcountries and India (SPOTLIGHT)
ovartis Healthcare Pvt Ltd0 sites0 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Observational
Eligibility Criteria
Inclusion Criteria
- •1. Male and female patients with clinical diagnosis of SCD (based on laboratory parameters)
- •of any genotype.
- •2. Patients newly initiated on treatment with locally approved crizanlizumab.
- •3. Patients aged 16 years or older at crizanlizumab initiation.
Exclusion Criteria
- •1. Patients who did not provide informed consent.
- •2. Patients who received a stem cell transplant at the time of enrollment.
- •3. Patients who participated in or participating in a clinical trial at the time of enrollment or
- •in the 12 months prior to starting commercial crizanlizumab.
- •4. According to the investigatorâ??s opinion, the patient is an unlikely candidate to provide an
- •accurate medical history and/or to obtain long-term follow-up information for any reasons
- •such as unavailability or severe concomitant illnesses.
Investigators
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