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Efficacy and Safety of Eltrombopag to correct thrombocytopenia in moderate to severe dengue patients- a Phase II Randomized Controlled Clinical Trial

Efficacy and Safety of Eltrombopag to correct thrombocytopenia in moderate to severe dengue patients- a Phase II Randomized Clinical Controlled Trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
SLCTR
Registry ID
SLCTR/2019/037
Enrollment
100
Registered
2019-10-09
Start date
2019-10-10
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). In total 100 Dengue Haemorrhagic Fever (DHF) and/or Dengue Shock Syndrome (DSS) patients will be enrolled and subsequently assig

Sponsors

Incepta Pharmaceuticals Ltd.
Lead Sponsor

Eligibility

Inclusion 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

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.

Design outcomes

Primary

MeasureTime frame
Proportion of patients considered recovered (i.e platelet count above 150×109/L) [Day 4 – 7] Mean platelet count [ Day 0 - 7]

Secondary

MeasureTime frame
Evaluation of the safety of Eltrombopag in dengue infected patients will constitute the secondary outcome. Serum SGPT/SGOT lower or equal at Day 5 in comparison to initial values at Day 0 will be considered as safe. [Day 0 and 5. .] Ultra-sonogram (USG) will be performed at day 4 to assess the portal vein thrombosis of the treated patients. No sign of portal vein thrombosis will be considered as safe. [ Day 4]

Countries

Bangladesh

Contacts

Public ContactDr. Ahmedul Kabir

Professor

ahmedul_986@yahoo.com880-2-9661900/7636

Outcome results

None listed

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