Health Condition 1: D570- Hb-SS disease with crisis
Conditions
Interventions
None listed
Sponsors
Indian Council for Medical Research
BITS Pilani K K Birla Goa Campus
Sai Phytoceutical P Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Confirmed cases of SCD with moderate to severe recurrent episodes who had experienced at-least 3 painful or vasoocclusive crises (VOC) in the previous year 2. Age between 5 to 45 years. 3. Homozygous sickle cell disease or Sbeta 0 thalassemia SS, SC, S beta thalassemia)as confirmed by CE electrophoresis (Gazelle Hb variant) and HPLC 4. Hemoglobin 5-10 gdL (both male and female) 5. Adults who are willing to use contraception during the course of treatment. 6. Willing to adhere to study procedures and to give written informed consent.
Exclusion criteria
Exclusion criteria: 1. Any acute sickle cell events that require hospitalization of patients within 1 month at enrollment. 2. Hemoglobin less than 5 gdL 3. Patients who received blood transfusion in last 3 months before enrollment. 4. Patients with clinical features of AIDS, Hepatitis or TB. 5. Patients with pregnancy or lactation 6. Patients with history of hypersensitivity reactions 7. Patients not willing or unable to follow instructions regarding treatment. 8. Patients with AST and/or ALT more than 3 times upper limit of normal or any sign of hepatic impairment or creatinine more than 2 times upper limit renal dysfunction 9. Patients with QTc interval of more than 470 msec at screening and patients with congenital long QT syndrome. 10. Chronic illness and pain disorders other than SCD such as leg ulcers, fever, fractures causing pain. 11. Is unstable or suffering from major psychiatric disorder such as schizophrenia or suicidal ideation 12. Refusal to provide access to relevant medical records or Consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the efficacy of Sailin-HbS by monitoring the following: 1) Reduction in the frequency of vaso-occlusive crises (VOC) by at least 33%. 2) Extension/prolongation of the interval between VOC occurrences by at least 33%.Timepoint: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of safety and monitoring of adverse drug events.Timepoint: 12 Months;Reduction in blood transfusion requirement by at least 33%.Timepoint: 12 Months;To assess the effect of Sailin-HbS on the frequency of hospital admissions.Timepoint: 12 Months;To evaluate Sailin-HbS impact on markers of hemolysis, including lactate dehydrogenase (LDH) and liver function tests (LFT).Timepoint: 12 Months | — |
Countries
India
Contacts
Public ContactProf Dr Rabindra Kumar Jena
Birla Institute of Technology and Science, Pilani K K Birla Goa Campus
Outcome results
None listed