Trials / Unknown
UnknownNCT04518878
Fixed Low-dose Eltrombopag and rhTPO for Immune Thrombocytopenia (FLOWER)
Combination of Fixed Low-dose Eltrombopag and rhTPO for Treatment of Immune Thrombocytopenia
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Peking University People's Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Eltrombopag | Fixed dose of eltrombopag oral 25mg daily |
| DRUG | rhTPO | Rh-TPO 300U/kg subcutaneous injection once daily for 7 consecutive days, followed by a tapering dose in maintenance therapy. |
Timeline
- Start date
- 2020-08-31
- Primary completion
- 2021-12-01
- Completion
- 2022-06-01
- First posted
- 2020-08-19
- Last updated
- 2020-09-01
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT04518878. Inclusion in this directory is not an endorsement.