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Clinical Trials/CTRI/2024/04/066222
CTRI/2024/04/066222
Not yet recruiting
Phase 2

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

Indian Council for Medical Research0 sites0 target enrollmentTBD
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Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Not specified
Sponsor
Indian Council for Medical Research
Status
Not yet recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional

Investigators

Sponsor
Indian Council for Medical Research

Eligibility 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

  • •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.

Outcomes

Primary Outcomes

Not specified

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