Pathophysiological investigations of sickle cell disease and interventions to improve associated hemorheological abnormalities - NA

Indian Council for Medical Research0 个研究点目标入组 0 人开始时间: 待定最近更新: 2024年4月29日

试验速览

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•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.

•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

发起方

Indian Council for Medical Research