Home » Trials » SLCTR/2019/037


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

-

SLCTR Registration Number

SLCTR/2019/037


Date of Registration

09 Oct 2019

The date of last modification

Oct 09, 2019



Application Summary


Scientific Title of Trial

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


Public Title of Trial

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


Disease or Health Condition(s) Studied

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


Scientific Acronym

DEN-ELTP-PLTC


Public Acronym

DEN-ELTP


Brief title

Eltrombopag to correct thrombocytopenia in dengue


Universal Trial Number

U1111-1231-1943


Any other number(s) assigned to the trial and issuing authority

BMRC/NREC/2016-2019/171


Trial Details


What is the research question being addressed?

Is eltrombopag efficacious and safe in correcting thrombocytopaenia in moderate to severe dengue patients?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Single blinded : Investigators, Data analysts


Control

Standard therapy/practice


Assignment

Parallel


Purpose

Treatment


Study Phase

Phase 2


Intervention(s) planned

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 assigned to one of three groups.Unequal randomization method will be used. The randomization will be done with computer generated random numbers that specify one of the three group numbers (1 or 2 or 3). Patients will be randomized in to Group 1, Group 2 and Group 3 in a 2:2:1 ratio. Interventions in the three groups are, Group 1: Eltrombopag 25 mg once daily for 3 days Group 2: Eltrombopag 50 mg once daily for 3 days Group 3: Standard treatment with fluids and support for 3 days

Last two days Day 4 and Day 5 will be dedicated for follow-up.


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.



Primary outcome(s)

1.

Proportion of patients considered recovered (i.e platelet count above 150×109/L)

[

Day 4 – 7

]
2.

Mean platelet count

[

Day 0 - 7

]

Secondary outcome(s)

1.

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. .

]
2.

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

]

Target number/sample size

100


Countries of recruitment

Bangladesh


Anticipated start date

2019-10-10


Anticipated end date

2020-01-30


Date of first enrollment


Date of study completion


Recruitment status

Pending


Funding source

Incepta Pharmaceuticals Limited, Bangladesh


Regulatory approvals

BMRC (Bangladesh Medical Research Council)



State of Ethics Review Approval


Status

Approved


Date of Approval

2019-08-22


Approval number

BMRC/NREC/2016-2019/171


Details of Ethics Review Committee

Name: Bangladesh Medical Research Council
Institutional Address: BMRC Bhaban, Mohakhali, Dhaka-1212
Telephone:+880 2 9848396
Email: info@bmrcbd.org

Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Dr. Ahmedul Kabir
Professor
Department of Medicine, Dhaka Medical College Hospital, Dhaka, Bangladesh.
880-2-9661900/7636
880-1720910541

ahmedul_986@yahoo.com
http://www.dmc.gov.bd/site/page/ab68b8aa-53c6-40be-9510-bfb99dcd30ca/-

Contact Person for Public Queries

Dr. Sajib Chakraborty
Associate Professor
Department of Biochemistry and Molecular biology, University of Dhaka, Dhaka.
880-2-9661900/7636
01632375041

sajib@du.ac.bd
http://univdhaka.edu/faculty/faculty_details/BCH/1536


Primary study sponsor/organization

Incepta Pharmaceuticals Ltd.
N/A
40 Shahid Tajuddin Ahmed Sarani Tejgaon I/A, Dhaka-1208.
880-2-8891190

mizan@inceptapharma.com
http://www.inceptapharma.com/send-us-enquiry.php

Secondary study sponsor (If any)







Trial Completion details


Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

Yes


IPD sharing plan description

Individual participant data that underlie the results being reported, after de-identification (text, tables, figures and appendices). Documents that will be shared include: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytical code. This will be shared Immediately following publication. Data will be shared with researchers who provide a methodologically sound proposal. Data will be shared with types of analyses which achieve the aims in an approved proposal. Proposals should be directed to ahmedul_986@yahoo.com and sajib@du.ac.bd. To gain access, the data requester will need to sign a data access agreement. Data will be available for 5 years from the time of publication at https://www.icpsr.umich.edu/icpsrweb/.


Study protocol available

Yes


Protocol version and date

Immediately after publication


Protocol URL


Results summary available

No


Date of posting results


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results