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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2017-08-31

Brief Summary

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

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Detailed Description

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Conditions

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Immune Thrombocytopenia (ITP)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1 mcg/kg AMG531

The administration of Romiplostim will be performed on Day 1 and 8

Group Type EXPERIMENTAL

Romiplostim

Intervention Type DRUG

3 mcg/kg AMG531

The administration of Romiplostim will be performed on Day 1 and 8

Group Type EXPERIMENTAL

Romiplostim

Intervention Type DRUG

Interventions

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Romiplostim

Intervention Type DRUG

Other Intervention Names

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AMG531

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No