Fixed Low-dose Eltrombopag and rhTPO for Immune Thrombocytopenia (FLOWER)

  • STATUS
    Recruiting
  • days left to enroll
    29
  • participants needed
    30
  • sponsor
    Peking University People's Hospital
Updated on 26 January 2021
corticosteroids
thrombocytopenia
covid-19
recombinant human thrombopoietin
eltrombopag
autoimmune thrombocytopenia

Summary

This is a prospective, single-arm study to investigate the efficacy and safety of the combination of fixed low-dose eltrombopag plus recombinant human thrombopoietin (rhTPO) as treatment for corticosteroid-resistant or relapsed immune thrombocytopenia (ITP) patients during the COVID-19 pandemic.

Description

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.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.

Both eltrombopag and rhTPO demonstrated good safety in ITP patients. Because of their non-immunosuppressive nature, both of them serve as a reasonable choice during the global COVID-19 pandemic.

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 treatment of corticosteroid-resistant or relapsed ITP patients.

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 IdentifierNCT04518878
SponsorPeking University People's Hospital
Last Modified on26 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Clinically confirmed corticosteroid-resistant or relapsed immune thrombocytopenic purpura (ITP)
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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