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Efficacy and Safety Study of Maintenance Treatment With rhTPO in Thrombocytopenic Subjects With ITP

Primary Purpose

Thrombocytopenia, Immune Thrombocytopenia, Idiopathic Thrombocytopenic Purpura

Status

Unknown status

Phase

Phase 3

Locations

China

Study Type

Interventional

Intervention

rhTPO

About this trial

This is an interventional treatment trial for Thrombocytopenia focused on measuring ITP, rhTPO

Eligibility Criteria

14 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Meeting the diagnostic criteria for immune thrombocytopenia (idiopathic thrombocytopenic purpura).
Subject with resistance to or relapse after glucocorticoid in the treatment of ITP, not accepts splenectomy, or subject with ineffective or relapse after surgical splenectomy.
Two consecutive platelet counts (not in the same day) < 30×10^9/L.
Subject is willing and able to provide written informed consent.

Exclusion Criteria:

Pregnancy or breast feeding.
Having a medical history of thrombosis.
Significant abnormal cardio-pulmonary function.
Abnormal liver and kidney function:
- a serum creatinine concentration≥ 176.8µmol/l (1.5mg/dl);
- a serum aminotransferase concentration: more than 2.0 times the upper limit of the normal range.
- a serum bilirubin concentration: more than 2.0 times the upper limit of the normal range.
Synchronous tumor.
Cannot adopt adequate contraceptive precautions during the course of the study.
Any other treatment drugs for ITP are being taken (except the duration of reducing glucocorticoid dosage as ineffective treatment ).
Any other situation that is not suitable for participating in the trial according to the judgment of the investigator .

Sites / Locations

Peking Union Medical College HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

rhTPO

Arm Description

Active investigational product

Outcomes

Primary Outcome Measures

The effective rate of maintenance treatment (the platelet count continued to be over 30 × 10^9/L)

Secondary Outcome Measures

The effective rate of maintenance treatments adopting different frequency of administration

Number of subjects with Adverse Events as a Measure of Safety

Full Information

NCT ID

NCT01805648

First Posted

February 22, 2013

Last Updated

March 4, 2013

Sponsor

Peking Union Medical College

Collaborators

Shenyang Sunshine Pharmaceutical Co., LTD.

1. Study Identification

Unique Protocol Identification Number

NCT01805648

Brief Title

Efficacy and Safety Study of Maintenance Treatment With rhTPO in Thrombocytopenic Subjects With ITP

Official Title

A Multicenter, Single-Arm, Open Label Study Evaluating the Efficacy and Safety of Maintenance Treatment With Recombinant Human Thrombopoietin in Thrombocytopenic Subjects With Immune Thrombocytopenia

Study Type

Interventional

2. Study Status

Record Verification Date

March 2013

Overall Recruitment Status

Unknown status

Study Start Date

February 2011 (undefined)

Primary Completion Date

August 2013 (Anticipated)

Study Completion Date

December 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Peking Union Medical College

Collaborators

Shenyang Sunshine Pharmaceutical Co., LTD.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of rhTPO in the maintenance treatment of ITP, to explore the appropriate dosing interval of the maintenance treatment of rhTPO .

Detailed Description

The eligible subjects with ITP firstly will receive a pre-treatment of rhTPO 300 IU/Kg once daily up to 14 days. The subjects with two consecutive platelet counts above 50×10^9/L in the pre-treatment period will begin to receive maintenance treatment of rhTPO 300 IU/Kg for 12 weeks. In the period of maintenance treatment, starting dosing interval of rhTPO is every other day followed by the interval adjustments for keeping platelet counts between 30 ×10^9/L～100 ×10^9/L. Subsequently, subjects will stop treatment of rhTPO and be followed up for 4 weeks after maintenance treatment. Platelet count, bleeding and other symptoms will be evaluated before and after treatment. Platelet transfusion will be administered to subjects with active bleeding symptoms. Toxicity will be monitored continuously during the entire study. Safety will be assessed by adverse events and laboratory tests.

6. Conditions and Keywords

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

Thrombocytopenia, Immune Thrombocytopenia, Idiopathic Thrombocytopenic Purpura

Keywords

ITP, rhTPO

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

rhTPO

Arm Type

Experimental

Arm Description

Active investigational product

Intervention Type

Drug

Intervention Name(s)

rhTPO

Other Intervention Name(s)

Recombinant Human Thrombopoietin, Recombinant Human TPO

Intervention Description

Subcutaneously dosing of rhTPO is based on screening weight. Subjects will be given rhTPO 300 IU/Kg once daily up to 14 days in the pre-treatment period . When two consecutive platelet counts is above 50×10^9/L, the subjects will be begin to receive maintenance treatment of rhTPO 300 IU/Kg. In the period of maintenance treatment, starting dosing interval of rhTPO is every other day followed by the interval adjustments for keeping platelet counts between 30×10^9/L～100×10^9/L.

Primary Outcome Measure Information:

Title

The effective rate of maintenance treatment (the platelet count continued to be over 30 × 10^9/L)

Time Frame

up to 16 weeks per subject

Secondary Outcome Measure Information:

Title

The effective rate of maintenance treatments adopting different frequency of administration

Time Frame

up to 16 weeks per subject

Title

Number of subjects with Adverse Events as a Measure of Safety

Time Frame

up to 18 weeks per subject

10. Eligibility

Sex

All

Minimum Age & Unit of Time

14 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Meeting the diagnostic criteria for immune thrombocytopenia (idiopathic thrombocytopenic purpura). Subject with resistance to or relapse after glucocorticoid in the treatment of ITP, not accepts splenectomy, or subject with ineffective or relapse after surgical splenectomy. Two consecutive platelet counts (not in the same day) < 30×10^9/L. Subject is willing and able to provide written informed consent. Exclusion Criteria: Pregnancy or breast feeding. Having a medical history of thrombosis. Significant abnormal cardio-pulmonary function. Abnormal liver and kidney function: a serum creatinine concentration≥ 176.8µmol/l (1.5mg/dl); a serum aminotransferase concentration: more than 2.0 times the upper limit of the normal range. a serum bilirubin concentration: more than 2.0 times the upper limit of the normal range. Synchronous tumor. Cannot adopt adequate contraceptive precautions during the course of the study. Any other treatment drugs for ITP are being taken (except the duration of reducing glucocorticoid dosage as ineffective treatment ). Any other situation that is not suitable for participating in the trial according to the judgment of the investigator .

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Yongqiang Zhao, Dr.

535114726@qq.com

First Name & Middle Initial & Last Name or Official Title & Degree

Shujie Wang

yangwl2007@yahoo.cn

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yongqiang Zhao, Dr.

Organizational Affiliation

Peking Union Medical College

Official's Role

Principal Investigator

Facility Information:

Facility Name

Peking Union Medical College Hospital

City

Beijing

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Shujie Wang, Dr.

yangwl2007@yahoo.cn

First Name & Middle Initial & Last Name & Degree

Yongqiang Zhao, Dr.

First Name & Middle Initial & Last Name & Degree

Shujie Wang, Dr.

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety Study of Maintenance Treatment With rhTPO in Thrombocytopenic Subjects With ITP

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