Eltrombopag Plus rhTPO Versus Eltrombopag for ITP During the COVID-19 Pandemic (ELABORATE-19)

Phase

Condition

Immune (Idiopathic) Thrombocytopenic Purpura (Itp)

Thrombocytopenia And Thrombocytopenia Prevention

Platelet Disorders

Treatment

N/A

Clinical Study ID

NCT04516837

ITP-PKU020

Ages 18-80
All Genders

Study Summary

This is a prospective, multicenter, randomized, open-label study to investigate the efficacy and safety of eltrombopag plus recombinant human thrombopoietin (rhTPO) versus eltrombopag as treatment for corticosteroid-resistant or relapsed immune thrombocytopenia (ITP) during the COVID-19 pandemic.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Clinically confirmed corticosteroid-resistant or relapsed immune thrombocytopenicpurpura (ITP)
Platelet count less than 30×10^9/L on two occasions or Platelets above 30×10^9/Lcombined with bleeding manifestation (WHO bleeding scale 2 or above)
Subject is ≥ 18 years
Subject has signed and provided written informed consent.
Fertile patients must use effective contraception during treatment and observationalperiod
Negative pregnancy test

Exclusion

Exclusion Criteria:

Have an impaired renal function as indicated by a serum creatinine level > 2.0 mg/dL
Have an inadequate liver function as indicated by a total bilirubin level > 2.0 mg/dLand/or an aspartate aminotransaminase or alanine aminotransferase level > 3×upperlimit of normal
Have a New York Heart Classification III or IV heart disease
Have a history of severe psychiatric disorder or are unable to comply with study andfollow-up procedures
Have active hepatitis B or hepatitis C infection
Have a HIV infection
Have active infection requiring antibiotic therapy within 7 days prior to study entry
Are pregnant or lactating women, or plan to become pregnant or impregnated within 12months of receiving study drug
Previous splenectomy
Had previous or concomitant malignant disease
Not willing to participate in the study.
Expected survival of < 2 years
Intolerant to murine antibodies
Immunosuppressive treatment within the last 2 weeks
Connective tissue disease
Autoimmune hemolytic anemia
Patients currently involved in another clinical trial with evaluation of drugtreatment

Study Design

August 31, 2020

August 31, 2022

Study Description

During the COVID-19 pandemic, the classical subsequent treatment regimen for ITP of immunosuppressants and/or steroids might increase patients' susceptibility of virus infections. To minimize ITP patients' risk during the COVID-19 global crisis and to improve treatment efficacy, this treatment regimen of eltrombopag plus recombinant human thrombopoietin (rhTPO) should be investigated.

Recombinant human thrombopoietin (rhTPO) is a full-length glycosylated-TPO produced by Chinese hamster ovary cells, which showed its effectiveness in ITP in a variety of studies.

Eltrombopag, a small molecule agonist of thrombopoietin receptor (TPO-RA), was recommended as the subsequent treatment for ITP patients, which also already showed robust efficacy.

Both eltrombopag and rhTPO demonstrated good safety in ITP patients. Since they increase the number of platelets through different mechanisms, and previous studies demonstrated that they might exert synergic effect. The investigators hypothesized that the combination of these two agents could be a promising option for ITP treatment.

This study aimed to evaluate the sustained responses and safety of eltrombopag plus rhTPO as treatment for corticosteroid-resistant or relapsed ITP patients during the COVID-19 pandemic.

Connect with a study center

Peking University Insititute of Hematology, Peking University People's Hospital
Beijing, Beijing 100010
China
Active - Recruiting

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