Evaluating the Pharmacokinetics and Pharmacodynamics of Romiplostim in Patients With Immune Thrombocytopenia (ITP)

Kyowa Kirin

Status and phase

Completed

Phase 2

Phase 1

Conditions

Immune Thrombocytopenia (ITP)

Treatments

Drug: Romiplostim

Study type

Interventional

Funder types

Industry

Identifiers

531-CN001

Details and patient eligibility

About

The objective of evaluating the pharmacokinetics and pharmacodynamics of romiplostim in patients with immune thrombocytopenia.

Enrollment

16 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosed with immune thrombocytopenia (ITP) for at least 6 months prior to signing the informed consent form (ICF).
Subject is ≥ 18 years old and ≤ 70 years old while signing the ICF.
Patients who have no response or relapsed after splenectomy. Or patients who have not been splenectomised and have completed at least 1 prior treatment for ITP. Excluded having previously received recombinant human thrombopoietin (rHuTPO) or any other thrombopoietin receptor agonist.
The mean of 3 scheduled platelet counts taken during the screening period must be: < 30 ×10^9/L, with none >35×10^9/L.

Exclusion criteria

Any known history of bone marrow stem cell disorder. Any abnormal bone marrow findings other than typical of ITP.
Any active malignancy. If prior history of cancer other than basal cell carcinoma or cervical carcinoma in situ, no treatment or active disease within 5 years prior to signing the ICF.
Had received Eltrombopag, recombinant human thrombopoietin (rHuTPO) or other myeloproliferative leukemia (MPL) stimulation product.
Received hematopoietic growth factors (e.g., granulocyte colony-stimulating factor, macrophage colony-stimulating factor, erythropoietin, interleukin-11) for any reason within 4 weeks prior to signing the ICF.
Received any anti-malignancy agents (e.g., cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, interferon-alfa) for any reason within 8 weeks prior to signing the ICF.
Received any monoclonal antibody drugs (e.g., rituximab) for any reason within 14 weeks prior to signing the ICF.
Less than 4 weeks since end of any clinical trials about therapeutic drug or device for any indication prior to signing the ICF.
Pregnant or breast feeding.
In the opinions of the principal investigator or investigators, the patients are not suitable for participation in this trial.