Efficacy and Safety of Eltrombopag to correct thrombocytopenia in moderate to severe dengue patients- a Phase II Randomized Controlled Clinical Trial
Phase 2
- Conditions
- Dengue Fever (DF), Dengue Haemorregic Fever (DHF) and Dengue Shock Syndrome (DSS)
- Registration Number
- SLCTR/2019/037
- Lead Sponsor
- Incepta Pharmaceuticals Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow up complete
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
a. Age: More than 15 years and less than 65 years
b. NS1 positivity within 4 days and or /(IgM or IgG) positive after 7 days
c. Platelet count: below 1,00,000/mm3
Exclusion Criteria
a. Known Pregnancy.
b. Thrombocytopenia caused by other factor such as Severe Aplastic Anemia (SAA), Chronic
Liver Disease (CLD) and Immune- thrombocytopenia (ITP).
c. ALT/AST levels higher than 5 times of upper normal limit.
d. History of portal vein thrombosis.
e. Patients infected with HCV, HBV, chronic liver disease (Drug induced, alcohol induced).
f. Patients with any history of receiving immunosuppressive therapy.
g. Patients with any severe co-morbidity.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method