CTRI/2020/11/029254尚未招募2 期
An Open Label, Single Arm, Pilot Clinical study To Evaluate The Efficacy and Safety of HPLT031707 SYRUP in Cases of Thrombocytopenia due to varied etiology in Pediatric Population.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Both male and female pediatric subjects between the age group of >=2 years to <= 12 years
- •2. Paediatric subjects who are diagnosed with thrombocytopenia (platelet count between 50000 cells/mm3 to 1 Lakh cells/mm3) due to any of the following conditions:
- •i Infection conditions which are associated with mild to moderate thrombocytopenia viz., associated with dengue fever, malaria, typhoid
- •ii Any other chronic conditions which require transient increase in platelet counts (like injection, tooth extract or injury) to avoid any possible bleeding).
- •Acute Immune thrombocytopenic purpura (ITP)
- •Post-Viral infections/ Post Immunization such as Hepatitis C, B, H1N1 and MMR.
- •iii Exposure to certain medications or toxins: Other than drugs/ toxins causing drug-induced hypoplasia of the bone marrow
- •Sedatives and anticonvulsant agents (carbamazepine, phenytoin, valproic acid)
- •Analgesic agents (acetaminophen, diclofenac, naproxen)
- •Diuretic agents â?? chlorothiazide
- •Heparins (Unfractionated heparin, low-molecular-weight heparin)
- •Cinchona alkaloids (quinine, quinidine)
- •Platelet inhibitors (abciximab, eptifibatide, tirofiban)
- •Antirheumatic agents (Gold salts, D-penicillamine)
- •Antimicrobial agents (linezolid, rifampin, sulfonamides, vancomycin)
- •Histamine-receptor antagonists - cimetidine
- •3. Parents/Guardians/Caregiver related to paediatric subject willing to give written informed consent for his/her child to participate in the study
- •4. Paediatric subject aged > 7 years of age willing to provide oral assent for his/her participation in the study.
- •5. Paediatric subjects who have not participated in this kind of trial in the past 4 weeks.
排除标准
- •1. Paediatric subjects with platelet count <50000/μL or more than 1 Lakh cells/mm3.
- •2. Paediatric subjects weighing <10 Kgs and >45Kgs.
- •3. Paediatric subjects with any febrile condition with temperature >103 0F and with a history of any febrile seizures
- •4. Paediatric subjects presenting with haemorrhagic phenomena at Day 1 (screening/baseline) e.g. evidence of petechiae, ecchymoses, bleeding from the oral mucosa, gastrointestinal tract (hematemesis or melaena.), injection sites or other locations.
- •5. Paediatric subjects diagnosed with any haemorrhagic phenomenon or shock as assessed by hypotension, hypovolemia and dehydration
- •6. Paediatric subjects with the history of juvenile diabetes mellitus treated with medication.
- •7. Paediatric subjects with a history of established hematological disorders including leukemia and hemophilia.
- •8. Paediatric subjects with a history of established malignancy, which requires cytotoxic chemotherapy.
- •9. Paediatric subjects who have received blood products or blood/platelet transfusion within one month of screening.
- •10. Paediatric subjects who are hypersensitive to any of the ingredients of the study medication.
研究者
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