Fixed Low-dose Eltrombopag and rhTPO for Immune Thrombocytopenia (FLOWER)
NCT ID: NCT04518878
Last Updated: 2020-09-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
30 participants
INTERVENTIONAL
2020-08-31
2022-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Fixed Low-dose Eltrombopag and rhTPO
Fixed Low-dose Eltrombopag and rhTPO
Eltrombopag
Fixed dose of eltrombopag oral 25mg daily
rhTPO
Rh-TPO 300U/kg subcutaneous injection once daily for 7 consecutive days, followed by a tapering dose in maintenance therapy.
Interventions
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Eltrombopag
Fixed dose of eltrombopag oral 25mg daily
rhTPO
Rh-TPO 300U/kg subcutaneous injection once daily for 7 consecutive days, followed by a tapering dose in maintenance therapy.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
80 Years
ALL
No
Sponsors
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Peking University People's Hospital
OTHER
Responsible Party
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Xiao Hui Zhang
Vice president of Peking Univeristy Institute of Hematology
Principal Investigators
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Xiaohui Zhang, MD
Role: PRINCIPAL_INVESTIGATOR
Peking University People's Hospital, Peking University Insititute of Hematology
Locations
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Peking University Insititute of Hematology, Peking University People's Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ITP-PKU019
Identifier Type: -
Identifier Source: org_study_id
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