SLCTR/2019/037
Completed
Phase 2
Efficacy and Safety of Eltrombopag to correct thrombocytopenia in moderate to severe dengue patients- a Phase II Randomized Clinical Controlled Trial
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Dengue Fever (DF), Dengue Haemorregic Fever (DHF) and Dengue Shock Syndrome (DSS)
- Sponsor
- Incepta Pharmaceuticals Ltd.
- Enrollment
- 100
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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