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
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SLCTR Registration Number
SLCTR/2019/037
Date of Registration
The date of last modification
Sep 15, 2020
Trial Status
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
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
2019-10-10
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
Incepta Pharmaceuticals Limited, Bangladesh
Regulatory approvals
BMRC (Bangladesh Medical Research Council)
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 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
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
