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

Peking University

Status: Unknown

Conditions: Corticosteroid-resistant or Relapsed ITP

Treatments: Drug: Eltrombopag; Drug: Recombinant human thrombopoietin (rh-TPO)

Study type: Observational

Funder types: Other

Identifiers

NCT04214951

ZXH-ITP2019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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 -

Trial design

100 participants in 2 patient groups

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.

Treatment:

Drug: Recombinant human thrombopoietin (rh-TPO)

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.

Treatment:

Drug: Eltrombopag