CTRI/2022/06/043467
Not yet recruiting
Phase 4
Prospective, observational study in Sickle Cell Diseasepatients on crizanlizumab treatment in Middle Eastcountries and India (SPOTLIGHT)
ovartis Healthcare Pvt Ltd0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ovartis Healthcare Pvt Ltd
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
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.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Recruiting
Phase 3
Long-term Follow-up of Subjects With Sickle Cell Disease Treated With Ex Vivo Gene Therapy Using Autologous Hematopoietic Stem Cells Transduced With a Lentiviral Vector2024-513901-30-00Bluebird Bio Inc.3
Recruiting
Phase 1
ong-term Follow-up of Subjects With Sickle Cell Disease Treated With Ex Vivo Gene Therapy Using Autologous Hematopoietic Stem Cells Transduced With a Lentiviral VectorCTIS2024-513901-30-00Bluebird Bio Inc.88
Terminated
Not Applicable
Prospective, Observational Study in Sickle Cell Disease Patients on Crizanlizumab Treatment in Middle East Countries and IndiaSickle Cell DiseaseNCT05020873Novartis Pharmaceuticals44
Recruiting
Not Applicable
Sickle Cell Outcome ResearchNL-OMON29491A1,000
Recruiting
Not Applicable
Sickle Cell Outcome REsearchNL-OMON55241Erasmus MC, Universitair Medisch Centrum Rotterdam1,000