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Evaluating the Pharmacokinetics and Pharmacodynamics of Romiplostim in Patients With Immune Thrombocytopenia (ITP) | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

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

NCT02868060•Kyowa Kirin China Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

Summary

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

Eligibility

Age

18 - 70 years

Sex

ALL

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.

Locations (5)

Peking Union hospital

Beijing, China

West China hospital

Chengdu, China

Chinese academy of medical science hematology hospital

Tianjin, China

Wuxi People's Hospital

Wuxi, China

Henan Cancer Hospital

Zhengzhou, China

Key Dates

Start Date

September 1, 2015

Primary Completion Date

August 1, 2017

Completion Date

August 1, 2017

Last Updated

April 29, 2024

Enrollment

ACTUAL participants

Conditions

Immune Thrombocytopenia (ITP)

Interventions

Romiplostim

DRUG

A Study of DZD8586 in Adults With Primary Immune Thrombocytopenia (ITP) (TAI-SHAN11)

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RECRUITINGPHASE1/PHASE2

A Study of CM336 in Patients With Relapsed or Refractory Autoimmune Cytopenia

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Autoimmune CytopeniaImmune Thrombocytopenia (ITP)+2 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 29, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study of DZD8586 in Adults With Primary Immune Thrombocytopenia (ITP) (TAI-SHAN11)

A Study of CM336 in Patients With Relapsed or Refractory Autoimmune Cytopenia

Safety Study of CC312 in Autoimmune Disease Patients

Phase 1b Trial of RAY121 in Immunological Diseases (RAINBOW Trial)

A Phase 1/2 Study of ESG206 in Patients With Primary Immune Thrombocytopenia

An Open, Exploratory Clinical Study of CM336 in the Treatment of Immune Thrombocytopenia