Fixed Low-dose Eltrombopag and rhTPO for Immune Thrombocytopenia (FLOWER)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
- Study Details
- Tabular View
- No Results Posted
- How to Read a Study Record
|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).
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 80 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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 > 3×upper 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
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, MDfirstname.lastname@example.org|
|Contact: Xuelin Dou, MDemail@example.com|
|Peking University Insititute of Hematology, Peking University People's Hospital||Recruiting|
|Beijing, Beijing, China, 100010|
|Contact: Xiaohui Zhang firstname.lastname@example.org|
|Principal Investigator:||Xiaohui Zhang, MD||Peking University People's Hospital, Peking University Insititute of Hematology|
|Responsible Party:||Xiao Hui Zhang, Vice president of Peking Univeristy Institute of Hematology, Peking University People's Hospital|
|Other Study ID Numbers:||
|First Posted:||August 19, 2020 Key Record Dates|
|Last Update Posted:||September 1, 2020|
|Last Verified:||August 2020|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
corticosteroid-resistant or relapsed ITP
recombinant human thrombopoietin (rhTPO)
Purpura, Thrombocytopenic, Idiopathic
Blood Platelet Disorders
Blood Coagulation Disorders
Immune System Diseases