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

NCT01805648 | Unknown Phase 3 DMC

• 1 other identifier: TPOzyq120725
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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 .

Conditions

Thrombocytopenia; Immune Thrombocytopenia; Idiopathic Thrombocytopenic Purpura

Keywords

ITP; rhTPO

Outcome Measures

Primary Outcomes (1)

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

  up to 16 weeks per subject

Secondary Outcomes (2)

• The effective rate of maintenance treatments adopting different frequency of administration

  up to 16 weeks per subject

• Number of subjects with Adverse Events as a Measure of Safety

  up to 18 weeks per subject

Study Arms (1)

rhTPO

EXPERIMENTAL

Active investigational product

Drug: rhTPO

Interventions

rhTPO DRUG

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.

Also known as: Recombinant Human Thrombopoietin, Recombinant Human TPO

rhTPO

Eligibility Criteria

• Age: 14 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Peking Union Medical College: lead
• Shenyang Sunshine Pharmaceutical Co., LTD.: collaborator

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Thrombocytopenia; Purpura, Thrombocytopenic, Idiopathic

Interventions

Thrombopoietin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Yongqiang Zhao, Dr.

  Peking Union Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yongqiang Zhao, Dr.

CONTACT

535114726@qq.com

Shujie Wang

CONTACT

yangwl2007@yahoo.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The Director of Hematology Department of Peking Union Medical College Hospital

Study Record Dates

• First Submitted: February 22, 2013
• First Posted: March 6, 2013
• Study Start: February 1, 2011
• Primary Completion: August 1, 2013
• Study Completion: December 1, 2013
• Last Updated: March 6, 2013

Record last verified: 2013-03

Locations

CN (1)