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

NCT02868060 | Completed Phase 1

• 1 other identifier: 531-CN001
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 5

Brief Summary

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

Conditions

Immune Thrombocytopenia (ITP)

Outcome Measures

Primary Outcomes (1)

• The incidence of all adverse events including evaluation of antidrug antibody status

  Up to 43 days after dosing

Study Arms (2)

1 mcg/kg AMG531

EXPERIMENTAL

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

Drug: Romiplostim

3 mcg/kg AMG531

EXPERIMENTAL

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

Drug: Romiplostim

Interventions

Romiplostim DRUG

Also known as: AMG531

1 mcg/kg AMG531; 3 mcg/kg AMG531

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kyowa Kirin China Pharmaceutical Co., Ltd.: lead

Study Sites (5)

Peking Union hospital

Beijing, China

Location

West China hospital

Chengdu, China

Location

Chinese academy of medical science hematology hospital

Tianjin, China

Location

Wuxi People's Hospital

Wuxi, China

Location

Henan Cancer Hospital

Zhengzhou, China

Location

Related Publications (1)

• Qi J, Zheng L, Hu B, Zhou H, He Q, Liu H, Kawai H, Yang R. Pharmacokinetics, Safety, and Pharmacodynamics of Romiplostim in Chinese Subjects With Immune Thrombocytopenia: A Phase I/II Trial. Clin Pharmacol Drug Dev. 2022 Mar;11(3):379-387. doi: 10.1002/cpdd.1059. Epub 2021 Dec 17.

  PMID: 34921514 DERIVED

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

romiplostim

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Study Officials

• Chinese academy of medical science hematology hospital

  Chinese academy of medical science hematology hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2016
• First Posted: August 16, 2016
• Study Start: September 1, 2015
• Primary Completion: August 1, 2017
• Study Completion: August 1, 2017
• Last Updated: April 29, 2024

Record last verified: 2024-04

Locations

CN (5)