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

Last updated: August 31, 2020
Sponsor: Peking University People's Hospital
Overall Status: Active - Recruiting

Phase

1

Condition

Immune (Idiopathic) Thrombocytopenic Purpura (Itp)

White Cell Disorders

Thrombosis

Treatment

N/A

Clinical Study ID

NCT04518878
ITP-PKU019
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Clinically confirmed corticosteroid-resistant or relapsed immune thrombocytopenicpurpura (ITP)

  2. Subject has signed and provided written informed consent.

  3. Fertile patients must use effective contraception during treatment and observationalperiod

  4. Negative pregnancy test

Exclusion

Exclusion Criteria:

  1. Have an impaired renal function as indicated by a serum creatinine level > 2.0 mg/dL

  2. 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

  3. Have a New York Heart Classification III or IV heart disease

  4. Have a history of severe psychiatric disorder or are unable to comply with study andfollow-up procedures

  5. Have active hepatitis B or hepatitis C infection

  6. Have a HIV infection

  7. Have active infection requiring antibiotic therapy within 7 days prior to study entry

  8. Are pregnant or lactating women, or plan to become pregnant or impregnated within 12months of receiving study drug

  9. Previous splenectomy

  10. Had previous or concomitant malignant disease

  11. Not willing to participate in the study.

  12. Expected survival of < 2 years

  13. Intolerant to murine antibodies

  14. Immunosuppressive treatment within the last 2 weeks

  15. Connective tissue disease

  16. Autoimmune hemolytic anemia

  17. Patients currently involved in another clinical trial with evaluation of drugtreatment

Study Design

Total Participants: 30
Study Start date:
August 31, 2020
Estimated Completion Date:
June 30, 2022

Study 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.

Connect with a study center

  • Peking University Insititute of Hematology, Peking University People's Hospital

    Beijing, Beijing 100010
    China

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.