Health Condition 1: D570- Hb-SS disease with crisis
Conditions
Interventions
Intervention1: Thalidomide: Thalidomide and Hydroxyurea
Intervention2: Addition of thalidomide: Interventiom-Addition of thalidomide and hydroxyurea
Comparator - Only Hydroxyurea
Intervention3: Thalid
Sponsors
Dr Anindita Paul
Eligibility
Inclusion criteria
Inclusion criteria: 1. Written informed consent must be obtained prior to any screening procedures 2. Male patients aged 12 years and older and post menopausal female patients above 45 years on the day of signing informed consent. 3. Confirmed diagnosis of SCD by hemoglobin electrophoresis [performed in the hospital setting]. 4. Patients with previous episodes of Vaso occlusive Crisis 5. Patients who havenâ??t been exposed to the use of HbF inducers other than HU
Exclusion criteria
Exclusion criteria: 1.Female patients of child bearing age group ( 15 -45years) 2.Patients with liver, renal, cardiac, pulmonary or neurological deficits 3.History of thrombotic episodes 4.Patient with active HIV infection (detectable viral load) 5.Patients with active Hepatitis B infection (HBsAg positive) 6.Positive test for hepatitis C infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| determining the reduction in Vaso-Occlusion Crisis (VOC) frequency by using pain scale ( Numeric Rating Scale)Timepoint: frequency by using pain scale ( Numeric Rating Scale) at 3 months, 6 months, 9 months, 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduction in blood transfusion requirementsTimepoint: every 3 months, 6 months, 9 months, 1 year | — |
Countries
India
Contacts
Public ContactDr Anindita Paul
IMS and SUM Hospital
Outcome results
None listed