A Study of Eltrombopag and Recombinant Human Thrombopoietin In Primary Immune Thrombocytopenia
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| ClinicalTrials.gov Identifier: NCT04214951 |
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Recruitment Status : Unknown
Verified October 2020 by Xiao Hui Zhang, Peking University People's Hospital.
Recruitment status was: Active, not recruiting
First Posted : January 2, 2020
Results First Posted : October 20, 2020
Last Update Posted : October 20, 2020
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Sponsor:
Peking University People's Hospital
Information provided by (Responsible Party):
Xiao Hui Zhang, Peking University People's Hospital
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Brief Summary:
Thrombopoietin Receptor Agonists (TPO-ra) are novel treatments for patients with refractory Primary Immune Thrombocytopenia (ITP). Rh-TPO and eltrombopag increase the number of platelets through different mechanism. If there is cross-resistance between 2 drugs for the treatment of adult ITP is still no answer. The purpose of this study is to investigate the efficacy and safety of switching eltrombopag and Rh-TPO in adults with ITP.
| Condition or disease | Intervention/treatment |
|---|---|
| Corticosteroid-resistant or Relapsed ITP | Drug: Eltrombopag Drug: Recombinant human thrombopoietin (rh-TPO) |
Non-interventional study. Patients who fail previous steroids and receive rh-TPO and then switch to EPAG or vice versa will be enrolled. The reason for switch will be recorded. Patients in the rh-TPO group were given rh-TPO 300 U/kg once daily for 21 days, and those in the eltrombopag group were given eltrombopag 50mg once daily for 6 weeks. Rh-TPO and eltrombopag were terminated any time the platelet counts increased above 100 × 10^9/L in the rh-TPO group and 300 × 10^9/L in the eltrombopag group. The efficacy, safety, and patient/physician preference will be assessed and compared between the two agents.
| Study Type : | Observational |
| Actual Enrollment : | 100 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | A Prospective Observational Study of Switching Eltrombopag and Recombinant Human Thrombopoietin In Primary Immune Thrombocytopenia |
| Actual Study Start Date : | January 1, 2020 |
| Estimated Primary Completion Date : | August 1, 2022 |
| Estimated Study Completion Date : | December 2022 |
Resource links provided by the National Library of Medicine
Drug Information available for:
Eltrombopag
| Group/Cohort | Intervention/treatment |
|---|---|
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Recombinant human thrombopoietin (rh-TPO) group
Patients who fail previous steroids and eltrombopag and then switch to Rh-TPO will be enrolled. The reason for switch will be recorded. Patients will be given rh-TPO 300 U/kg once daily for 21 days. Rh-TPO will be terminated any time the platelet counts increased above 100 × 10^9/L. The efficacy, safety, and patient/physician preference will be assessed.
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Drug: Recombinant human thrombopoietin (rh-TPO)
Patients will be given rh-TPO 300 U/kg once daily for 21 days. |
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Eltrombopag group
Patients who fail previous steroids and rh-TPO and then switch to eltrombopag will be enrolled. The reason for switch will be recorded. Patients will be given eltrombopag 50mg once daily for 6 weeks. Eltrombopag will be terminated any time the platelet counts increased above 300× 10^9/L.The efficacy, safety, and patient/physician preference will be assessed.
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Drug: Eltrombopag
Patients will be given eltrombopag 50mg once daily for 6 weeks. |
Primary Outcome Measures :
- Response Rate at 6 Weeks After Switching [ Time Frame: 6 weeks ]The percentage of patients who have reached platelet count ≥ 50×10^9/L at 6 weeks after switching.
Secondary Outcome Measures :
- Treatments Associated Adverse Events [ Time Frame: 6 weeks ]Adverse event/serious adverse event associated with study drugs during 6 weeks after switching
- Reasons of Switching [ Time Frame: 6 weeks ]Reasons of switching eltrombopag and rh-TPO will be recorded, including lack of efficacy, patient preference, side effects, platelet count fluctuation
- Number of Participants With Bleeding Events [ Time Frame: 6 weeks ]Number of participants with bleeding events of the two groups during 6 weeks after switching
- TOR (Time to Response) [ Time Frame: 6 weeks ]The time to achieve platelet count ≥ 50×10^9/L after switching.
- DOR (Duration of Response) [ Time Frame: 6 weeks ]The duration of achieving platelet count ≥ 50×10^9/L after switching.
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| Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Study Population
adult ITP patients
Criteria
Inclusion Criteria:
1.18 years or older
2.Primary ITP
3.Platelet count ≤ 30 × 109/l
4.Normal neutrophils, reticulocyte count, creatinine and liver enzyme values
5.Available follow-up of 2 months at least for each period
6.Failed initial glucocorticosteroid treatment
7.Unwillingness to accept splenectomy or failed splenectomy
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Exclusion Criteria:
- HIV, hepatitis B or C, Helicobacter pylori infection
- Malignancy
- Congenital or acquired immunologic deficit
- History of thrombosis plus two or more risk factors
- Nursing or pregnant women
- Abnormal liver and renal functions: AST/ALT/total bilirubin ≥1.5 × ULN, creatinine ≥1.5 mg/dl
- Severe heart and lung dysfunctions -
Information from the National Library of Medicine
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): NCT04214951
Locations
| China, Beijing | |
| Peking University Institute of Hematology | |
| Beijing, Beijing, China, 100044 | |
Sponsors and Collaborators
Peking University People's Hospital
Investigators
| Principal Investigator: | Xiao Hui Zhang, MD | Peking University People's Hospital |
Study Documents (Full-Text)
Documents provided by Xiao Hui Zhang, Peking University People's Hospital:
Documents provided by Xiao Hui Zhang, Peking University People's Hospital:
Study Protocol, Statistical Analysis Plan, and Informed Consent Form [PDF] August 13, 2020
Publications:
| Responsible Party: | Xiao Hui Zhang, Clinical Professor, Peking University People's Hospital |
| ClinicalTrials.gov Identifier: | NCT04214951 |
| Other Study ID Numbers: |
ZXH-ITP2019 |
| First Posted: | January 2, 2020 Key Record Dates |
| Results First Posted: | October 20, 2020 |
| Last Update Posted: | October 20, 2020 |
| Last Verified: | October 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 |
Keywords provided by Xiao Hui Zhang, Peking University People's Hospital:
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Immune Thrombocytopenia Recombinant human thrombopoietin Eltrombopag switching |
Additional relevant MeSH terms:
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Thrombocytopenia Purpura, Thrombocytopenic, Idiopathic Blood Platelet Disorders Hematologic Diseases Purpura, Thrombocytopenic Purpura Blood Coagulation Disorders |
Thrombotic Microangiopathies Hemorrhagic Disorders Autoimmune Diseases Immune System Diseases Hemorrhage Pathologic Processes Skin Manifestations |