Home » Trials » SLCTR/2022/023
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
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SLCTR Registration Number
SLCTR/2022/023
Date of Registration
The date of last modification
Jan 11, 2023
Scientific Title of 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
Public Title of Trial
Efficacy of Eltrombopag in correcting thrombocytopenia and preventing fluid leakage in moderate to severe dengue patients- a Phase III Randomized Placebo 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-III
Public Acronym
DEN-ELTP-III
Brief title
Eltrombopag to correct thrombocytopenia and prevent fluid leakage in dengue.
Universal Trial Number
U1111-1277-7650
Any other number(s) assigned to the trial and issuing authority
44120092021
What is the research question being addressed?
Is Eltrombopag efficacious compared to placebo in correcting thrombocytopenia and preventing fluid leakage in moderate dengue patients?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded : Participants, Investigators, Healthcare providers
Control
Placebo
Assignment
Parallel
Purpose
Treatment
Study Phase
Phase 3
Intervention(s) planned
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 Badda, Dhaka, and Better Life Hospital, Rampura, Dhaka, Bangladesh.
In total 300 Dengue Fever (DF), Dengue Haemorrhagic Fever (DHF), and/or Dengue Shock Syndrome (DSS) patients will be enrolled and subsequently assigned to one of two groups. A simple randomization method will be used. The randomization will be done with computer-generated random numbers that specify one of the two group numbers (1 or 2). Patients will be randomized into Group 1 and Group 2 in a 1:1 ratio. Interventions in the two groups are: Group 1: Eltrombopag 25 mg once daily for 3 days with standard treatment Group 2: Placebo with Standard treatment with fluids and support for 3 days. The placebo will be provided in three consecutive days at 25mg/day.
The last three days Day 4 and Day 6 will be dedicated to follow-up.
Details of the placebo is as follows: Excipients: Microcrystalline Cellulose (101), Mannitol, Povidone (K 30), Crospovidone (Type B), Sodium Starch Glycolate (Type A), Magnesium Stearate
Coating Materials: Opadry II Brown, Purified Water*
*Does not appear in the final product.
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
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.
Primary outcome(s)
|
1.
|
[ Day 4 – 7 ] |
|
2.
2.Mean platelet count |
[ Day 4 – 7 ] |
Secondary outcome(s)
|
1.
|
[ Day 4 – 7 ] |
|
2.
|
[ Day 4 – 7 ] |
Target number/sample size
300 (150 in each arm)
Countries of recruitment
Bangladesh
Anticipated start date
2022-10-18
Anticipated end date
2022-12-31
Date of first enrollment
Date of study completion
Recruitment status
Pending
Funding source
Incepta Pharmaceuticals Limited, Bangladesh
Regulatory approvals
BMRC (Bangladesh Medical Research Council)
Status
Approved
Date of Approval
2022-04-12
Approval number
44120092021
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. A H M Nurun Nabi
Professor
Department of Biochemistry and Molecular biology, University of Dhaka, Dhaka
880-2-9661920/9660
880-1914737989
nabi@du.ac.bd
https://www.du.ac.bd/faculty/faculty_details/BCH/1528
Contact Person for Public Queries
Dr. Sajib Chakraborty
Associate Professor
Department of Biochemistry and Molecular biology, University of Dhaka, Dhaka
880-2-9661900/7636
880-1632375041
sajib@du.ac.bd
https://du.ac.bd/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) will be shared. Data will be shared beginning 3 months and ending 5 years following article publication. Data will be shared with investigators whose proposed use of the data has been approved by an independent review committee identified for the purpose of achieving the aims in the approved proposal. Proposals should be directed to nabi@du.ac.bd.
Study protocol available
Yes
Protocol version and date
Upon 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
