Role of Eltrombopag as First Line Therapy in Primary Immune Thrombocytopenia.

NCT06531018 | Recruiting Phase 1 DMC

• 1 other identifier: 55603092023
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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 (1:1) 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.

Conditions

Primary Immune Thrombocytopenia

Keywords

Primary ITP; Eltrombopag; First-line Therapy

Outcome Measures

Primary Outcomes (2)

• Changes in Platelet count

  Compare change in platelet count in two groups

  28 days (platelet count will be measured at the end of 1st, 2nd and 4th week)

• Spontaneous bleeding

  Compare number of Spontaneous bleeding in two groups

  28 days (Spontaneous bleeding episodes will be noted by face to face interview at the end of 1st, 2nd and 4th week)

Secondary Outcomes (6)

• Changes in hemoglobin

  28 days (hemoglobin will be measured at the end of 1st, 2nd and 4th week)

• Changes in Total WBC count

  28days (WBC count will be measured at the end of 1st, 2nd and 4th week)

• Change in ALT

  28 days ( ALT will be measured at the end of 1st, 2nd and 4th week)

• Change in AST

  28 days ( AST will be measured at the end of 1st, 2nd and 4th week)

• Change in S.Createnine

  28 days (S.Createnine will be measured at the end of 1st, 2nd and 4th week)

Study Arms (2)

Eltrombopag Arm

EXPERIMENTAL

Eltrombopag + Prednsolone

Drug: Eltrombopag 25 MG; Drug: Prednisolone

Prednisolone alone arm

PLACEBO COMPARATOR

Placebo + Prednisolone

Drug: Prednisolone

Interventions

Eltrombopag 25 MG DRUG

Eltrombopag 25 mg daily and Prednisolone 1-2mg/kg, selected by block randomization from Day1 to Day 28. Both investigators and patients will be blinded.

Also known as: Prednisolone

Eltrombopag Arm

Prednisolone DRUG

Prednisolone 1-2 mg/kg and Placebo(same as eltrombopag 25mg Tablet), selected by block randomization from Day1 to Day 28. Both investigators and patients will be blinded.

Also known as: Placebo

Eltrombopag Arm; Prednisolone alone arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with newly diagnosed ITP
• Platelet Count ≤ 30x109/L
• Age between 18 to 70 years.

You may not qualify if:

• Persistent or chronic ITP
• Pregnant women
• Secondary ITP- ITP due to SLE, Anti-phospholipid syndrome, Evans syndrome, HCV or H Pylori associated ITP.
• History of vaccination, recent viral infection, fever
• Evan's Syndrome
• Known case of chronic renal failure or liver diseases
• Grade 3 or 4 bleeding at presentation.

Sponsors & Collaborators

• Renata PLC: lead

Study Sites (1)

Dhaka Medical College Hospital

Dhaka, 1000, Bangladesh

RECRUITING

Related Publications (5)

• Gomez-Almaguer D, Herrera-Rojas MA, Jaime-Perez JC, Gomez-De Leon A, Cantu-Rodriguez OG, Gutierrez-Aguirre CH, Tarin-Arzaga L, Hernandez-Reyes J, Ruiz-Arguelles GJ. Eltrombopag and high-dose dexamethasone as frontline treatment of newly diagnosed immune thrombocytopenia in adults. Blood. 2014 Jun 19;123(25):3906-8. doi: 10.1182/blood-2014-01-549360. Epub 2014 May 6.

  PMID: 24802773 RESULT

• Gomez-Almaguer D, Colunga-Pedraza PR, Gomez-De Leon A, Gutierrez-Aguirre CH, Cantu-Rodriguez OG, Jaime-Perez JC. Eltrombopag, low-dose rituximab, and dexamethasone combination as frontline treatment of newly diagnosed immune thrombocytopaenia. Br J Haematol. 2019 Jan;184(2):288-290. doi: 10.1111/bjh.15070. Epub 2017 Dec 21. No abstract available.

  PMID: 29270980 RESULT

• Gomez-Almaguer D. Eltrombopag-based combination treatment for immune thrombocytopenia. Ther Adv Hematol. 2018 Oct 4;9(10):309-317. doi: 10.1177/2040620718798798. eCollection 2018 Oct.

  PMID: 30344993 RESULT

• Provan D, Stasi R, Newland AC, Blanchette VS, Bolton-Maggs P, Bussel JB, Chong BH, Cines DB, Gernsheimer TB, Godeau B, Grainger J, Greer I, Hunt BJ, Imbach PA, Lyons G, McMillan R, Rodeghiero F, Sanz MA, Tarantino M, Watson S, Young J, Kuter DJ. International consensus report on the investigation and management of primary immune thrombocytopenia. Blood. 2010 Jan 14;115(2):168-86. doi: 10.1182/blood-2009-06-225565. Epub 2009 Oct 21.

  PMID: 19846889 RESULT

• Shimano KA, Grace RF, Despotovic JM, Neufeld EJ, Klaassen RJ, Bennett CM, Ma C, London WB, Neunert C. Phase 3 randomised trial of eltrombopag versus standard first-line pharmacological management for newly diagnosed immune thrombocytopaenia (ITP) in children: study protocol. BMJ Open. 2021 Aug 27;11(8):e044885. doi: 10.1136/bmjopen-2020-044885.

  PMID: 34452956 RESULT

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

eltrombopag; Prednisolone

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Md Manirul Islam, MBBS,FCPS

  Dhaka Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Md Manirul Islam, MBBS,FCPS

CONTACT

+8801715049573; manirk54@yahoo.com

Gazi Yeasinul Islam, MBBS,FCPS

CONTACT

+880171675995; yeasin100heam@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2024
• First Posted: July 31, 2024
• Study Start: February 7, 2025
• Primary Completion: August 31, 2025
• Study Completion: December 31, 2025
• Last Updated: February 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: From the starting of data collection to upto one year of the end of the study.
• Access Criteria: Via submitting request to PI via EMail

Locations

BA (1)