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

  • STATUS
    Recruiting
  • End date
    Aug 25, 2022
  • participants needed
    120
  • sponsor
    Peking University People's Hospital
Updated on 25 January 2021
platelet count
corticosteroids
thrombocytopenia
covid-19
recombinant human thrombopoietin
eltrombopag
autoimmune thrombocytopenia

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.

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.

Details
Condition IDIOPATHIC THROMBOCYTOPENIC PURPURA, Idiopathic Thrombocytopenic Purpura (ITP), Thrombocytopenic, Autoimmune disease, Autoimmune disease, Immune Thrombocytopenia, Idiopathic Thrombocytopenic Purpura (ITP), Thrombocytopenic, autoimmune thrombocytopenia
Treatment Eltrombopag, rhTPO
Clinical Study IdentifierNCT04516837
SponsorPeking University People's Hospital
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Clinically confirmed corticosteroid-resistant or relapsed immune thrombocytopenic purpura (ITP)
Platelet count less than 3010^9/L on two occasions or Platelets above 3010^9/L combined 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 observational period
Negative pregnancy test

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/dL and/or an aspartate aminotransaminase or alanine aminotransferase level > 3upper limit 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 and follow-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 12 months 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 drug treatment
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