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

Peking University People's Hospital100 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Corticosteroid-resistant or Relapsed ITP

Interventions

EltrombopagDRUG

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

Recombinant human thrombopoietin (rh-TPO)DRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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 -

Locations (1)

Peking University Institute of Hematology

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Response Rate at 6 Weeks After Switching

The percentage of patients who have reached platelet count ≥ 50×10\^9/L at 6 weeks after switching.

Time frame: 6 weeks

Secondary Outcomes

Treatments Associated Adverse Events

Adverse event/serious adverse event associated with study drugs during 6 weeks after switching

Time frame: 6 weeks

Reasons of Switching

Reasons of switching eltrombopag and rh-TPO will be recorded, including lack of efficacy, patient preference, side effects, platelet count fluctuation

Time frame: 6 weeks

Number of Participants With Bleeding Events

Number of participants with bleeding events of the two groups during 6 weeks after switching

Time frame: 6 weeks

TOR (Time to Response)

The time to achieve platelet count ≥ 50×10\^9/L after switching.

Time frame: 6 weeks

DOR (Duration of Response)

The duration of achieving platelet count ≥ 50×10\^9/L after switching.

Time frame: 6 weeks

Data from ClinicalTrials.gov

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