Efficacy of Eltrombopag in correcting thrombocytopenia and preventing fluid leakage in moderate to severe dengue patients- a Phase III Randomized Placebo Controlled Clinical Trial.
- Conditions
- Dengue Fever (DF), Dengue Haemorregic Fever (DHF) and Dengue Shock Syndrome (DSS)
- Registration Number
- SLCTR/2022/023
- Lead Sponsor
- Incepta Pharmaceuticals Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- Not specified
a.Age: More than 18 years and less than 65 years
b.Evidence of Dengue by Dengue NS1/Dengue IgM positive
c.Any one of the following warning signs:
abdominal pain or tenderness, persistent vomiting, clinical fluid accumulation (not due to any other causes), evidenced by Ultrasound of the Chest and whole abdomen, mucosal bleeding, lethargy, liver enlargement >2 cm, rising of hematocrit (>20% of baseline) concurrent with a rapid decline in platelet.
(defined by National guideline 2019 )
d.Platelet count: below 1,00,000/mm3
a.Known Pregnancy.
b.Patients with severe dengue (Category-3) and dengue shock syndrome
c.Abnormal liver function test.
d.SGPT >5 times of upper limit
e.Mild Dengue fever patient without warning signs (defined by National guideline 2019 )
f.Ascites due to another disease, eg- CLD, CKD, Disseminated TB, Malignancy.
g.Pleural Effusion due to other causes, eg- TB, Malignancy, CLD, CKD.
h.Thrombocytopenia caused by other factor such as Severe Aplastic Anemia (SAA), Chronic Liver Disease (CLD), and Immune- thrombocytopenia (ITP).
i.History of portal vein thrombosis.
j.Patients infected with HCV, HBV, chronic liver disease (Drug-induced, alcohol-induced).
k.Patients with any history of receiving immunosuppressive therapy.
l.Patients with any severe comorbidity.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method