CTRI/2020/01/022785尚未招募2 期
An Open Label, Single Arm Clinical study To Evaluate The Safety and Efficacy of HPLT031707 SYRUP in Cases of Thrombocytopenia Associated With Dengue Fever in Pediatric Population - PL_S
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 between >=2 years to <=12 years
- •2)Pediatric subjects already confirmed to have DF (Dengue Fever) through ELISA based NS1 Antigen test and/or IgM.
- •3)Pediatric subjects who have been clinically diagnosed with dengue fever associated with thrombocytopenia vis a vis platelet count between 50000 cells/mm3 to 1,00,000 cells/mm3.
- •4)Pediatric subjects with the SGPT level not more than twice the upper limit of the normal
- •5)Parents/Guardians/Caregiver related to pediatric subject willing to give written informed consent for his/her participation to the study
- •6)Pediatric subject aged > 7 years of age willing to sign the assent form for his/her participation in the study
- •7)Pediatric subjects who have not participated in this kind of trial in the past 4 weeks
排除标准
- •1)Pediatric subjects diagnosed with DHF Grade 3 or 4,with hypotension / hypovolemia and dehydration
- •2)Pediatric subjects with platelet count < 50000 cells/mm3
- •3)Pediatric subjects weighing <10 Kgs and >45 Kgs
- •4)Pediatric subjects with any febrile condition with temperature >=103 degree ofF and with a history of any febrile seizures.
- •5)Pediatric subjects presenting with hemorrhagic phenomena at Day 1 (screening/baseline) evidenced with petechiae, ecchymoses, or purpura, bleeding from the oral mucosa, gastrointestinal tract (hemetemesis or melaena.), injection sites or other locations.
- •7)Pediatric subjects with the history of juvenile diabetes mellitus treated with medication.
- •8)Pediatric subjects with the history of clinically significant cardiovascular condition treated with medication
- •9)Pediatric subjects with history of UTI or acute or chronic infectious condition and on any antibiotics like polymyxin B, rifampicin, amikacin, nalidixic acid, gentamycin, cholarmphenicol, oflaxacin
- •10)Pediatric subjects with a history of established hematological disorders including idiopathic thrombocytopenia purpura, leukemia, hemophilia
- •11)Pediatric subjects who have received blood products or blood/platelet transfusion during the current hospital stay or during last one month
- •12)Pediatric subjects who are hypersensitive to any of the ingredients of the study medication
- •13)Pediatric subjects with a history of clinically significant systemic condition treated with aspirin or corticosteroids or heparin
研究者
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