Efficacy and Safety of Romiplostim in Adult Subjects With Persistent or Chronic Immune Thrombocytopenia (ITP)

NCT02868099 | Completed Phase 3

• 1 other identifier: 531-CN002
• Study Type: interventional
• Target: 203
• Locations: 1 country
• Sites: 1

Brief Summary

The objective is to evaluate the efficacy and safety of romiplostim for injection in adlut subjects with persistent or chronic primary immune thrombocytopenia (ITP).

Conditions

Immune Thrombocytopenia

Outcome Measures

Primary Outcomes (1)

• Number of weeks in which the platelet response counts increase above 50×10^9/L

  6 weeks

Secondary Outcomes (2)

• Proportion of subjects whose platelet counts relative to the baseline increase ≥ 20×10^9/L

  6 weeks

• Proportion of subjects who have received emergency treatment to increase the platelet counts

  6 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Subjects received placebo for injection treatment will be administered subcutaneously once a week

Drug: Placebo

Drug

EXPERIMENTAL

Subjects received Romiplostim for injection treatment will be administered subcutaneously once a week

Drug: Romiplostim

Interventions

Romiplostim DRUG

Drug

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 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 while signing the ICF.
• Patients who have no response or relapsed after splenectomy. Or patients who have not been splenectomised and have no response or relapse to at least 1 prior treatment for immune thrombocytopenia (ITP).
• 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 those typical of ITP.
• Any active malignancy. If prior history of cancer other than basal cell carcinoma or cervical carcinoma in situ, and no treatment or active disease within 5 years prior to signing the ICF..
• 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 myeloproliferative leukemia (MPL) stimulation product other than the subject who had suspended recombinant human thrombopoietin (rHuTPO) for injection for 4 weeks before signing 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 prior to signing the ICF.
• Pregnant or breastfeeding.
• 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 (1)

Peking Union Medical College Hospital

Beijing, China

Location

Related Publications (1)

• Zhou H, Zhou J, Wu D, Ma L, Du X, Niu T, Yang R, Liu J, Zhang F, Shi Q, Wang X, Jing H, Li J, Wang X, Cui Z, Zhou Z, Hou M, Shao Z, Jin J, Li W, Ren H, Hu J, Shen J, Liu L, Zeng Y, Zhou J, Liu X, Shen Y, Ding K, Taira T, Cai H, Zhao Y. Romiplostim in primary immune thrombocytopenia that is persistent or chronic: phase III multicenter, randomized, placebo-controlled clinical trial in China. Res Pract Thromb Haemost. 2023 May 23;7(5):100192. doi: 10.1016/j.rpth.2023.100192. eCollection 2023 Jul.

  PMID: 37601010 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

• Peking Union Medical College Hospital,

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Placebo-controlled, Double-blinded then Open-label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: multi-center, Randomized, Placebo-controlled, Double-blinded then Open-label

Study Record Dates

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

Record last verified: 2024-04

Locations

CN (1)