Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06531018
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-06
Brief Title:
Role of Eltrombopag as First Line Therapy in Primary Immune Thrombocytopenia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy of Eltrombopag Prednisolone Versus Prednisolone Monotherapy in Newly Diagnosed Immune Thrombocytopenia- A Randomized Control Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EIT
Brief Summary:
This will be a double-blind placebo-control randomized clinical trial conducted in the Department of Hematology DMCH for one year This study will help to establish the role of eltrombopag as a first-line therapy in newly diagnosed ITP Newly diagnosed ITP patients will be selected after meeting inclusion and exclusion criteria they will be thoroughly informed about the study used drugs randomization risks benefits and follow-up If they agree to participate their consent will be taken and they will be enrolled in the study A detailed history and clinical exam will be done Primary investigation will be - CBC PBF RBS ANA TSH Anti H pyloriIgG Anti-HCV APTT and BMS if indicated The main outcome variable will be platelet count and number of spontaneous bleeding Total sample size would be 100 50 in each group Enrolled patients would be divided into two groups 11 by block randomization One group will get Eltrombopag Prednisolone and other group will get Eltrombopag Placebo Researchers or any one related to the study in DMCH patients their attendants no one will know which patient will get placebo or eltrombopag Only a respectable third party will know the information A patient would be followed up on 1st 2nd and 4th week of starting therapy Patients would be evaluated in every follow up by history physical examination and investigation History of any spontaneous bleeding event any discomfort or new symptoms science last follow up will be noted General examination will be performed in every follow-up CBC RBS ALT AST creatinine will be done in every follow-up Data will be collected on a pre-designed case record form and will be collected through face-to-face interviews physical examination and laboratory reports After data collection data will be edited cleaned and prepared for analysis at the end of the study The statistical analysis will be conducted using SPSS version 25 statistical software The results of the study will be published in national and international journals
Detailed Description:
Study procedure After meeting inclusion and exclusion criteria patients will be thoroughly informed about the study used drugs randomization risk and benefits follow up If they agree to participate in the study their consent for this study will be taken and they will be enrolled in the study
Detail history and clinical exam will be done Key points are- History of spontaneous bleeding in last month History of vaccination History of recent viral infection fever Presence of organomegaly
Primary investigation will be- CBC PBF RBS ANA TSH Anti H pyloriIgG Anti-HCV APTT BMS if indicated
NB
1 If APTT is more than 10 sec of control patient would be evaluated for Anti-Phospholipid Syndrome by anti-cardiolipin Antibody and Anti-beta2 glycoprotein1 Antibody
2 If Hemoglobin in less than 115gmdL patient would be evaluated for Anemia by Iron Profile or Coombs Test based on CBC parameter and PBF findings Randomization Enrolled patients would be divided into two groups 11 by block randomization Block Randomization would be done by computer generated pattern Actual randomization plan will be provided by Renata limited team who know about eltrombopag and placebo Randomization allocation delivered only to the enrolling site study staff A voluntary nurse will be in charge of enrolling the patients according to randomization plan
Blinding and placebo control It will be a double-blind study Researchers nor participants will know who is getting placeboeltromopag One group will get Prednisolone Eltrombopag and another group will get Prednisolone Placebo Eltrombopag Prednisolone and Placebo will be provided by Renata Limited Bangladesh and patient will get at free of costs Placebo will have same size shape color markings taste smell and packaging like Eltrombopag Eltrombopag and placebo will be provided in separate color-coded box marked-A red or B green Group A and Group B participants will be given colored cards red and green for identification They will receive tablets from marked box Researchers or any one related to the study in DMCH patients their attendants no will know which box contain placebo or eltrombopag Only respectable person of Renata limited will know the information The team who knows the information will be head by their CEO At the end point all data will be submitted to the team who know about placebo
Experimental Group - Eltrombopag Prednisolone Control Group - Prednisolone and Placebo Dose- Prednisolone 1mgkgday for 28 days EltrombopagPlacebo 25mgday for 28 days Follow Up- Follow up at the end of 1st week 2nd week and 4th week Patient would be evaluated in every follow up by history physical examination and investigation History of any spontaneous bleeding event any discomfort or new symptoms science last follow up General examination will be performed in every follow up CBC RBS ALT AST and creatinine will be done in every follow up
Primary End Point-28 days after starting therapy Complete Response is expected after 28 days of therapy
Patient would continue therapy and follow up in OPD but would not be included in the study
Supportive care and rescue- A Data and Safety Monitoring Board DSMB will be formed which will include two members of NREC one hematologist and one medicine specialist Any adverse event Drugs side effects- headache weight gain changes in liver enzymes high blood sugar or serious adverse event grade 3 or grade 4 bleeding hospitalization thrombosis will be delt with proper medical care
If any patient shows no response within 14 days and has grade 3 or 4 bleeding rescue with methyl prednisolone or IV Ig would be given and discontinued from study If group A patient reaches platelet count 400x109L eltrombopag will be stopped
Data Analysis After data collection data will be edited cleaned and prepared for analysis at the end of the study At the end of the study all data will be submitted to the team who know about placeboeltrombopag The statistical analysis will be conducted using SPSS statistical package for the social science version 25 statistical software The findings of the study will be presented by frequency and percentage in tables Means and standard deviations for continuous variables and proportion for categorical variables will be used to describe the characteristics of the total sample Association between two qualitative variables will be assessed by Chi-square test where p005 with 95 confidence level will be considered as significant Appropriate statistical tests will be done to interpret the findings of the study
Detail history and clinical exam will be done Key points are- History of spontaneous bleeding in last month History of vaccination History of recent viral infection fever Presence of organomegaly
Primary investigation will be- CBC PBF RBS ANA TSH Anti H pyloriIgG Anti-HCV APTT BMS if indicated
NB
1 If APTT is more than 10 sec of control patient would be evaluated for Anti-Phospholipid Syndrome by anti-cardiolipin Antibody and Anti-beta2 glycoprotein1 Antibody
2 If Hemoglobin in less than 115gmdL patient would be evaluated for Anemia by Iron Profile or Coombs Test based on CBC parameter and PBF findings Randomization Enrolled patients would be divided into two groups 11 by block randomization Block Randomization would be done by computer generated pattern Actual randomization plan will be provided by Renata limited team who know about eltrombopag and placebo Randomization allocation delivered only to the enrolling site study staff A voluntary nurse will be in charge of enrolling the patients according to randomization plan
Blinding and placebo control It will be a double-blind study Researchers nor participants will know who is getting placeboeltromopag One group will get Prednisolone Eltrombopag and another group will get Prednisolone Placebo Eltrombopag Prednisolone and Placebo will be provided by Renata Limited Bangladesh and patient will get at free of costs Placebo will have same size shape color markings taste smell and packaging like Eltrombopag Eltrombopag and placebo will be provided in separate color-coded box marked-A red or B green Group A and Group B participants will be given colored cards red and green for identification They will receive tablets from marked box Researchers or any one related to the study in DMCH patients their attendants no will know which box contain placebo or eltrombopag Only respectable person of Renata limited will know the information The team who knows the information will be head by their CEO At the end point all data will be submitted to the team who know about placebo
Experimental Group - Eltrombopag Prednisolone Control Group - Prednisolone and Placebo Dose- Prednisolone 1mgkgday for 28 days EltrombopagPlacebo 25mgday for 28 days Follow Up- Follow up at the end of 1st week 2nd week and 4th week Patient would be evaluated in every follow up by history physical examination and investigation History of any spontaneous bleeding event any discomfort or new symptoms science last follow up General examination will be performed in every follow up CBC RBS ALT AST and creatinine will be done in every follow up
Primary End Point-28 days after starting therapy Complete Response is expected after 28 days of therapy
Patient would continue therapy and follow up in OPD but would not be included in the study
Supportive care and rescue- A Data and Safety Monitoring Board DSMB will be formed which will include two members of NREC one hematologist and one medicine specialist Any adverse event Drugs side effects- headache weight gain changes in liver enzymes high blood sugar or serious adverse event grade 3 or grade 4 bleeding hospitalization thrombosis will be delt with proper medical care
If any patient shows no response within 14 days and has grade 3 or 4 bleeding rescue with methyl prednisolone or IV Ig would be given and discontinued from study If group A patient reaches platelet count 400x109L eltrombopag will be stopped
Data Analysis After data collection data will be edited cleaned and prepared for analysis at the end of the study At the end of the study all data will be submitted to the team who know about placeboeltrombopag The statistical analysis will be conducted using SPSS statistical package for the social science version 25 statistical software The findings of the study will be presented by frequency and percentage in tables Means and standard deviations for continuous variables and proportion for categorical variables will be used to describe the characteristics of the total sample Association between two qualitative variables will be assessed by Chi-square test where p005 with 95 confidence level will be considered as significant Appropriate statistical tests will be done to interpret the findings of the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None