OW DOSE THALIDOMIDE VERSUS HYDROXYUREA IN TRANSFUSION DEPENDENT THALASSEMIA PATIENTS
- Conditions
- Health Condition 1: D569- Thalassemia, unspecified
- Registration Number
- CTRI/2020/05/025142
- Lead Sponsor
- ALKA RANI KHADWA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
1.Treatment naive adult transfusion dependent thalassemia patients of either sex willing to give written informed consent.
2.Age more than 18 years.
1.Those with active systemic comorbidity, with past personal or family history of thrombophilia and recent splenectomy (within 3 months).
2.Absolute neutrophil count (ANC) less than 2000/ mm3 in the 8 weeks before study entry or a history of chronic neutropenia, defined as an ANC less than 2000/mm3.
3. Platelet count less than 100,000/mm3 or greater than 1,000,000/mm3 in the 8 weeks before study entry.
4.Evidence of liver disease, as defined by one or more of the following conditions: Alanine aminotransferase (ALT) level greater than three times the upper limit of normal in the 8 weeks before study entry. Serum albumin level less than 3 g/dL in the 8 weeks before study entry.
5.Creatinine level more than twice the upper limit of normal for age or greater than 1.5mg/dl.
6.Pregnant, planning to become pregnant, or breastfeeding.
7.HCV/HBV/HIV infection.
8.Currently being treated with any other experimental or fetal hemoglobin-modulating agent.
9. Current participation in any other studies of investigational drugs or devices.
10. Baseline peripheral neuropathy symptoms equivalent to grade 2 Therapy-induced peripheral neuropathy (TiPN) will be excluded.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method