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

April 25, 2024 updated by: Kyowa Kirin China Pharmaceutical Co., Ltd.
The objective of evaluating the pharmacokinetics and pharmacodynamics of romiplostim in patients with immune thrombocytopenia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China
        • Peking Union hospital
      • Chengdu, China
        • West China Hospital
      • Tianjin, China
        • Chinese academy of medical science hematology hospital
      • Wuxi, China
        • Wuxi People's Hospital
      • Zhengzhou, China
        • Henan Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1 mcg/kg AMG531
The administration of Romiplostim will be performed on Day 1 and 8
Drug: Romiplostim
Other Names:
  • AMG531
Experimental: 3 mcg/kg AMG531
The administration of Romiplostim will be performed on Day 1 and 8
Drug: Romiplostim
Other Names:
  • AMG531

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The incidence of all adverse events including evaluation of antidrug antibody status
Time Frame: Up to 43 days after dosing
Up to 43 days after dosing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyowa Kirin China Pharmaceutical Co., Ltd.

Investigators

  • Principal Investigator: Chinese academy of medical science hematology hospital, Chinese academy of medical science hematology hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

August 11, 2016

First Submitted That Met QC Criteria

August 11, 2016

First Posted (Estimated)

August 16, 2016

Study Record Updates

Last Update Posted (Actual)

April 29, 2024

Last Update Submitted That Met QC Criteria

April 25, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 531-CN001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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