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

Primary Purpose

Immune Thrombocytopenia

Status

Completed

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

Romiplostim

Placebo

About this trial

This is an interventional treatment trial for Immune Thrombocytopenia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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 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.

Exclusion Criteria:

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.

Sites / Locations

Peking Union Medical College Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Drug

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

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

Full Information

NCT ID

NCT02868099

First Posted

August 11, 2016

Last Updated

August 15, 2017

Sponsor

Kyowa Kirin China Pharmaceutical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02868099

Brief Title

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

Official Title

A Multi-center, Randomized, Placebo-controlled, Double-blinded Then Open 2 Stages Clinical Trial to Evaluate the Efficacy and Safety of Romiplostim in Adult Subjects With Persistent or Chronic Primary Immune Thrombocytopenia (ITP)

Study Type

Interventional

2. Study Status

Record Verification Date

August 2016

Overall Recruitment Status

Completed

Study Start Date

September 2015 (Actual)

Primary Completion Date

February 2017 (Actual)

Study Completion Date

June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Kyowa Kirin China Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Immune Thrombocytopenia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

ParticipantInvestigator

Masking Description

Placebo-controlled, Double-blinded then Open-label

Allocation

Randomized

Enrollment

203 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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

Arm Title

Drug

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Romiplostim

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

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

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

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

Time Frame

6 weeks

Title

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

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peking Union Medical College Hospital,

Organizational Affiliation

Peking Union Medical College Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Peking Union Medical College Hospital

City

Beijing

Country

China

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

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

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