Eltrombopag Combining Rituximab Versus Eltrombopag in the Management of Primary Immune Thrombocytopenia (ITP) in Adults

NCT04518475 | Recruiting Phase 4

• 1 other identifier: IIT2020011
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

Brief Summary

This multicenter randomized, open-label study aimed to compare the efficacy and safety of eltrombopag combining rituximab with eltrombopag in China adult ITP patients .This study was be conducted in adult ITP patients who had not responded to or had relapsed after previous treatment of ITP, including first line therapy and /or splenectomy.

Conditions

Primary Immune Thrombocytopenia (ITP)

Keywords

immune thrombocytopenia; autoantibody; eltrombopag; rituximab

Outcome Measures

Primary Outcomes (1)

• Treatment response

  Number of participants achieving a platelet count \>=30×10\^9/L and at least doubling of the baseline count at Week 4, Week 8, and Week 12 .

  From the start of study treatment (Day 1) up to the end of week 12.

Secondary Outcomes (9)

• Drug efficacy

  From the start of study treatment (Day 1) up to the end of week 4, week 8 and week 12.

• Long-term treatment response

  From the start of study treatment (Day 1) up to the end of week 16, week 20 and week 24

• Time to Response

  From the start of study treatment (Day 1) up to the end of week 24

• Duration of response

  From the start of study treatment (Day 1) up to the end of week 24.

• Evaluation of effectiveness

  From the start of study treatment (Day 1) up to the end of week 24.

Study Arms (2)

efficacy of eltrombopag combining rituximab

EXPERIMENTAL

After enrollment,all subjects receive eltrombopag treatment,the initial dose of eltrombopag administration was an oral 75 mg once daily.Complete blood count including platelet count was done once a week.The dose of eltrombopag was adjusted according to the subject platelet count during the period from week 1 to week 24. If the platelet count \>250×10\^9/L, the eltrombopag will stop until the platelet count \<30×10\^9/L. All subjects receive single dose infusion of rituximab 375 mg/m(2) within 14 days after enrollment. Efficacy and safety will be evaluated at Week 4, Week 8, and Week 12.

Drug: eltrombopag combining rituximab

efficacy of eltrombopag

ACTIVE COMPARATOR

After enrollment,all subjects receive eltrombopag treatment,the initial dose of eltrombopag administration was an oral 75 mg once daily.Complete blood count including platelet count was done once a week.The dose of eltrombopag was adjusted according to the subject platelet count during the period from week 1 to week 24. If the platelet count \>250×10\^9/L, the eltrombopag will stop until the platelet count \<30×10\^9/L. Efficacy and safety will be evaluated at Week 4, Week 8, and Week 12.

Drug: eltrombopag

Interventions

eltrombopag combining rituximab DRUG

After enrollment,all subjects receive eltrombopag treatment,the initial dose of eltrombopag administration was an oral 75 mg once daily.Complete blood count including platelet count was done once a week.The dose of eltrombopag was adjusted according to the subject platelet count during the period from week 1 to week 24. If the platelet count \>250×10\^9/L, the eltrombopag will stop until the platelet count \<30×10\^9/L. All subjects receive single dose infusion of rituximab 375 mg/m(2) within 14 days after enrollment. Efficacy and safety will be evaluated at Week 4, Week 8, and Week 12.

Also known as: TPO-R agonist & anti-CD20 antibody

efficacy of eltrombopag combining rituximab

eltrombopag DRUG

After enrollment,all subjects receive eltrombopag treatment,the initial dose of eltrombopag administration was an oral 75 mg once daily.Complete blood count including platelet count was done once a week.The dose of eltrombopag was adjusted according to the subject platelet count during the period from week 1 to week 24. If the platelet count \>250×10\^9/L, the eltrombopag will stop until the platelet count \<30×10\^9/L. Efficacy and safety will be evaluated at Week 4, Week 8, and Week 12.

Also known as: TPO-R agonist

efficacy of eltrombopag

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Signed written informed consent
• Age from 18 to 60 years old
• Diagnosed with ITP and have a platelet count of \<30 ×10\^9/L on Day 1 (or within 48 hours prior to dosing on Day 1).
• Patients who have no response or relapsed after splenectomy(at least more than 6 months). Or patients who have not been splenectomised and have either not responded to one or more prior therapies, or who have relapsed prior therapy.
• Subjects treated with previous therapy(including but not limited to corticosteroid, azathioprine, danazol, cyclosporin A, mycophenolate mofetil) must have been completed prior to randomization, or must not be increasing a dose after enrollment.
• No pre-existing cardiac disease within the last 3 months. No arrhythmia known to increase the risk of thrombolic events (e.g. atrial fibrillation), or patients with a Corrected QT interval (QTc) \>450msec or QTc \>480 for patients with a Bundle Branch Block.
• No pre-existing infection within the last 1 months(including but not limited to pulmonary infection)
• Laboratory tests for coagulation function showed that prothrombin time (PT/INR) and activated partial thromboplastin time (APTT) no exceed normal by more than 20%. No history of clotting disorder, other than ITP.
• White blood cell count, neutrophil absolute value, hemoglobin, within the reference range, with the following exceptions:
• The following blood chemistry test result no exceed normal by more than 20%:alanine aminotransferase, aspartate aminotransferase, total bilirubin, creatinine,serum albumin must not be below the lower limit of normal (LLN) by more than 10%.
• Subject is non-childbearing potential of childbearing potential and use acceptable methods of contraception throughout the study.
• Subjects fully understand and are able to comply with the requirements of the research protocol and are willing to complete the study as planned.

You may not qualify if:

• Patients with any prior history of arterial or venous thrombosis, and with following risk factors: cancer, Factor V Leiden, ATIII deficiency, antiphospholipid syndrome.
• Pregnant or lactating women;
• Subjects is currently receiving treatment with another study medication.
• Any laboratory or clinical evidence for HIV infection.
• Any clinical history for hepatitis C infection; chronic hepatitis B infection; or any evidence for active hepatitis at the time of subject screening. Laboratory test shows positive serology for Hepatitis C or Hepatitis B (HB). In addition, if negative for HBsAg but HBcAb positive (regardless of HBsAb status), a HB DNA test will be performed and if positive the subject will be excluded.
• History of platelet aggregation that prevents reliable measurement of platelet counts.
• Any clinically relevant abnormality, other than ITP,which in the opinion of the investigator makes the subject unsuitable for participation in the study.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead
• The Second Affiliated Hospital of Kunming Medical University: collaborator
• Henan Cancer Hospital: collaborator
• Tianjin Medical University Second Hospital: collaborator
• The First Affiliated Hospital of Xiamen University: collaborator
• Affiliated Hospital of Nantong University: collaborator

Study Sites (1)

Institute of Hematology and Blood Diseases Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Tianjin, China

RECRUITING

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

eltrombopag

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

Study Officials

• Lei Zhang, M.D., Ph.D

  Institute of Hematology & Blood Diseases Hospital, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei Zhang

CONTACT

+86 13502118379; zhanglei1@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2020
• First Posted: August 19, 2020
• Study Start: August 10, 2020
• Primary Completion (Estimated): February 10, 2029
• Study Completion (Estimated): August 10, 2030
• Last Updated: April 29, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)