A Study of Eltrombopag and Recombinant Human Thrombopoietin In Primary Immune Thrombocytopenia

A Prospective Observational Study of Switching Eltrombopag and Recombinant Human Thrombopoietin In Primary Immune Thrombocytopenia

Sponsors

Lead Sponsor: Peking University People's Hospital

Source Peking University People's Hospital
Brief Summary

Thrombopoietin Receptor Agonists (TPO-ra) are novel treatments for patients with refractory Primary Immune Thrombocytopenia (ITP). Rh-TPO and eltrombopag increase the number of platelets through different mechanism. If there is cross-resistance between 2 drugs for the treatment of adult ITP is still no answer. The purpose of this study is to investigate the efficacy and safety of switching eltrombopag and Rh-TPO in adults with ITP.

Detailed Description

Non-interventional study. Patients who fail previous steroids and receive rh-TPO and then switch to EPAG or vice versa will be enrolled. The reason for switch will be recorded. Patients in the rh-TPO group were given rh-TPO 300 U/kg once daily for 21 days, and those in the eltrombopag group were given eltrombopag 50mg once daily for 6 weeks. Rh-TPO and eltrombopag were terminated any time the platelet counts increased above 100 × 10^9/L in the rh-TPO group and 300 × 10^9/L in the eltrombopag group. The efficacy, safety, and patient/physician preference will be assessed and compared between the two agents.

Overall Status Active, not recruiting
Start Date January 1, 2020
Completion Date December 2022
Primary Completion Date August 1, 2022
Study Type Observational
Primary Outcome
Measure Time Frame
Response Rate at 6 Weeks After Switching 6 weeks
Secondary Outcome
Measure Time Frame
Treatments Associated Adverse Events 6 weeks
Reasons of Switching 6 weeks
Number of Participants With Bleeding Events 6 weeks
TOR (Time to Response) 6 weeks
DOR (Duration of Response) 6 weeks
Enrollment 100
Condition
Intervention

Intervention Type: Drug

Intervention Name: Eltrombopag

Description: Patients will be given eltrombopag 50mg once daily for 6 weeks.

Arm Group Label: Eltrombopag group

Intervention Type: Drug

Intervention Name: Recombinant human thrombopoietin (rh-TPO)

Description: Patients will be given rh-TPO 300 U/kg once daily for 21 days.

Arm Group Label: Recombinant human thrombopoietin (rh-TPO) group

Eligibility

Sampling Method: Probability Sample

Criteria:

Inclusion Criteria: 1.18 years or older 2.Primary ITP 3.Platelet count ≤ 30 × 109/l 4.Normal neutrophils, reticulocyte count, creatinine and liver enzyme values 5.Available follow-up of 2 months at least for each period 6.Failed initial glucocorticosteroid treatment 7.Unwillingness to accept splenectomy or failed splenectomy - Exclusion Criteria: 1. HIV, hepatitis B or C, Helicobacter pylori infection 2. Malignancy 3. Congenital or acquired immunologic deficit 4. History of thrombosis plus two or more risk factors 5. Nursing or pregnant women 6. Abnormal liver and renal functions: AST/ALT/total bilirubin ≥1.5 × ULN, creatinine ≥1.5 mg/dl 7. Severe heart and lung dysfunctions -

Gender: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Xiao Hui Zhang, MD Principal Investigator Peking University People's Hospital
Location
Facility: Peking University Institute of Hematology
Location Countries

China

Verification Date

October 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Peking University People's Hospital

Investigator Full Name: Xiao Hui Zhang

Investigator Title: Clinical Professor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: Recombinant human thrombopoietin (rh-TPO) group

Description: Patients who fail previous steroids and eltrombopag and then switch to Rh-TPO will be enrolled. The reason for switch will be recorded. Patients will be given rh-TPO 300 U/kg once daily for 21 days. Rh-TPO will be terminated any time the platelet counts increased above 100 × 10^9/L. The efficacy, safety, and patient/physician preference will be assessed.

Label: Eltrombopag group

Description: Patients who fail previous steroids and rh-TPO and then switch to eltrombopag will be enrolled. The reason for switch will be recorded. Patients will be given eltrombopag 50mg once daily for 6 weeks. Eltrombopag will be terminated any time the platelet counts increased above 300× 10^9/L.The efficacy, safety, and patient/physician preference will be assessed.

Patient Data No
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov