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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Peking Union Medical College
Sponsor:
Collaborator:
Shenyang Sunshine Pharmaceutical Co., LTD.
Information provided by (Responsible Party):
Yongqiang Zhao, Peking Union Medical College
ClinicalTrials.gov Identifier:
NCT01805648
First received: February 22, 2013
Last updated: March 4, 2013
Last verified: March 2013
  Purpose

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 .


Condition Intervention Phase
Thrombocytopenia
Immune Thrombocytopenia
Idiopathic Thrombocytopenic Purpura
Drug: rhTPO
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Peking Union Medical College:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The effective rate of maintenance treatments adopting different frequency of administration [ Time Frame: up to 16 weeks per subject ] [ Designated as safety issue: No ]
  • Number of subjects with Adverse Events as a Measure of Safety [ Time Frame: up to 18 weeks per subject ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: February 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: rhTPO
Active investigational product
Drug: rhTPO
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.
Other Names:
  • Recombinant Human Thrombopoietin
  • Recombinant Human TPO

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.

  Eligibility

Ages Eligible for Study:   14 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 .
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01805648

Contacts
Contact: Yongqiang Zhao, Dr. 535114726@qq.com
Contact: Shujie Wang yangwl2007@yahoo.cn

Locations
China
Peking Union Medical College Hospital Recruiting
Beijing, China
Contact: Shujie Wang, Dr.       yangwl2007@yahoo.cn   
Principal Investigator: Yongqiang Zhao, Dr.         
Sub-Investigator: Shujie Wang, Dr.         
Sponsors and Collaborators
Peking Union Medical College
Shenyang Sunshine Pharmaceutical Co., LTD.
Investigators
Principal Investigator: Yongqiang Zhao, Dr. Peking Union Medical College
  More Information

No publications provided

Responsible Party: Yongqiang Zhao, The Director of Hematology Department of Peking Union Medical College Hospital, Peking Union Medical College
ClinicalTrials.gov Identifier: NCT01805648     History of Changes
Other Study ID Numbers: TPOzyq120725
Study First Received: February 22, 2013
Last Updated: March 4, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Peking Union Medical College:
ITP
rhTPO

Additional relevant MeSH terms:
Thrombocytopenia
Purpura
Purpura, Thrombocytopenic
Purpura, Thrombocytopenic, Idiopathic
Blood Coagulation Disorders
Hematologic Diseases
Hemorrhage
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Thrombotic Microangiopathies
Blood Platelet Disorders
Immune System Diseases
Hemorrhagic Disorders
Autoimmune Diseases

ClinicalTrials.gov processed this record on July 28, 2014