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

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ClinicalTrials.gov Identifier: NCT04518878
Recruitment Status : Unknown
Verified August 2020 by Xiao Hui Zhang, Peking University People's Hospital.
Recruitment status was:  Recruiting
First Posted : August 19, 2020
Last Update Posted : September 1, 2020
Sponsor:
Information provided by (Responsible Party):
Xiao Hui Zhang, Peking University People's Hospital

Tracking Information
First Submitted Date  ICMJE August 16, 2020
First Posted Date  ICMJE August 19, 2020
Last Update Posted Date September 1, 2020
Actual Study Start Date  ICMJE August 31, 2020
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 16, 2020)
  • Complete response [ Time Frame: 6 weeks ]
    A complete response (CR) was defined as a sustained (≥ 3 months) platelet count ≥ 100×10^9/L.
  • Response [ Time Frame: 6 weeks ]
    A response (R) was defined as a sustained (≥ 3 months) platelet count ≥ 30×10^9/L without recurrence of thrombocytopenia.
  • No response [ Time Frame: 6 weeks ]
    No response (NR) was defined as platelet count < 30 × 10^9/L or a less than two fold increase in platelet count from baseline or the presence of bleeding. Platelet count must be measured on two occasions more than a day apart.
  • Relapses [ Time Frame: 6 weeks ]
    A relapses was defined as platelet count falls below 30×10^9/L or bleeding accrues after achieving R or CR.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 16, 2020)
  • Early response [ Time Frame: 7 days ]
    Early response was defined as the attainment of a platelet count ≥ 30 × 10⁹ and at least a doubling of baseline platelet count at 1 week.
  • Initial response [ Time Frame: 1 month ]
    Initial treatment was defined as the attainment of a platelet count ≥ 30 × 10⁹ and at least a doubling of baseline platelet count at 1 month.
  • TOR (time to response) [ Time Frame: 6 weeks ]
    The time to achieve platelet count ≥ 30×10^9/L and at least 2-fold increase of the baseline count and absence of bleeding since start of treatment.
  • DOR (duration of response) [ Time Frame: 6 weeks ]
    The duration of achieve platelet count ≥ 30×10^9/L and at least 2-fold increase of the baseline count and absence of bleeding since start of treatment.
  • Treatments associated adverse events [ Time Frame: 6 weeks ]
    All patients were assessed for safety every week during the first 8 weeks of treatment, and at 2-week intervals thereafter. Adverse events were scaled according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
  • Reduction in bleeding symptoms [ Time Frame: 6 weeks ]
    Changes of bleeding after treatment. Bleeding was defined in accordance with the WHO bleeding scale (0, no bleeding; 1, petechiae; 2, mild blood loss; 3, gross blood loss; and 4, debilitating blood loss).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fixed Low-dose Eltrombopag and rhTPO for Immune Thrombocytopenia (FLOWER)
Official Title  ICMJE Combination of Fixed Low-dose Eltrombopag and rhTPO for Treatment of Immune Thrombocytopenia
Brief 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.
Detailed 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Immune Thrombocytopenia
Intervention  ICMJE
  • Drug: Eltrombopag
    Fixed dose of eltrombopag oral 25mg daily
    Other Name: Revolade
  • Drug: rhTPO
    Rh-TPO 300U/kg subcutaneous injection once daily for 7 consecutive days, followed by a tapering dose in maintenance therapy.
    Other Name: TPIAO, tebiao
Study Arms  ICMJE Experimental: Fixed Low-dose Eltrombopag and rhTPO
Fixed Low-dose Eltrombopag and rhTPO
Interventions:
  • Drug: Eltrombopag
  • Drug: rhTPO
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 16, 2020)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2022
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Clinically confirmed corticosteroid-resistant or relapsed immune thrombocytopenic purpura (ITP)
  2. Subject has signed and provided written informed consent.
  3. Fertile patients must use effective contraception during treatment and observational period
  4. Negative pregnancy test

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/dL and/or an aspartate aminotransaminase or alanine aminotransferase level > 3×upper limit 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 and follow-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 12 months 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 drug treatment
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04518878
Other Study ID Numbers  ICMJE ITP-PKU019
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Xiao Hui Zhang, Peking University People's Hospital
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Peking University People's Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Xiaohui Zhang, MD Peking University People's Hospital, Peking University Insititute of Hematology
PRS Account Peking University People's Hospital
Verification Date August 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP