Fixed Low-dose Eltrombopag and rhTPO for Immune Thrombocytopenia (FLOWER)
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|ClinicalTrials.gov Identifier: NCT04518878|
Recruitment Status : Recruiting
First Posted : August 19, 2020
Last Update Posted : September 1, 2020
|Condition or disease||Intervention/treatment||Phase|
|Immune Thrombocytopenia||Drug: Eltrombopag Drug: rhTPO||Phase 1|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Combination of Fixed Low-dose Eltrombopag and rhTPO for Treatment of Immune Thrombocytopenia|
|Actual Study Start Date :||August 31, 2020|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||June 2022|
Experimental: Fixed Low-dose Eltrombopag and rhTPO
Fixed Low-dose Eltrombopag and rhTPO
Fixed dose of eltrombopag oral 25mg daily
Other Name: Revolade
Rh-TPO 300U/kg subcutaneous injection once daily for 7 consecutive days, followed by a tapering dose in maintenance therapy.
Other Name: TPIAO, tebiao
- 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.
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04518878
|Contact: Xiaohui Zhang, MDemail@example.com|
|Contact: Xuelin Dou, MDfirstname.lastname@example.org|
|Peking University Insititute of Hematology, Peking University People's Hospital||Recruiting|
|Beijing, Beijing, China, 100010|
|Contact: Xiaohui Zhang email@example.com|
|Principal Investigator:||Xiaohui Zhang, MD||Peking University People's Hospital, Peking University Insititute of Hematology|