Efficacy of Eltrombopag in correcting thrombocytopenia and preventing fluid leakage in moderate to severe dengue patients- a Phase III Randomized Placebo Controlled Clinical Trial.

Double Blind Placebo Controlled Randomized Phase III trial to evaluate the efficacy of Eltrombopag to correct thrombocytopenia and prevent fluid leakage in moderate dengue patients

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

SLCTR

Registry ID

SLCTR/2022/023

Enrollment

Unknown

Registered

2022-10-17

Start date

2022-10-18

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dengue Fever (DF), Dengue Haemorregic Fever (DHF) and Dengue Shock Syndrome (DSS)

Interventions

The study will be carried out in Dhaka Medical College Hospital (DMCH), Sir Salimullah Medical College & Mitford Hospital, Mugda Medical College Hospital, Square Hospital, Dhaka, AMZ Hospital, North

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

Measure	Time frame
1. Proportion of patients considered recovered (i.e platelet count above 150×10^9/L) [Day 4 – 7] 2.Mean platelet count [ Day 4 – 7]	—

Secondary

Measure	Time frame
1. The proportion of patients with the manifestation of fluid leakage. [Day 4 – 7] 2. Severity of fluid leakage (Hematocrit (HCT) monitoring). [Day 4 – 7]	—

Countries

Bangladesh

Contacts

Public ContactDr. A H M Nurun Nabi

Professor

nabi@du.ac.bd880-2-9661920/9660

Outcome results

None listed

Source: SLCTR (via WHO ICTRP) · Data processed: Aug 9, 2026