Recombinant Human Thrombopoietin (rhTPO) in Management of Immune Thrombocytopenia (ITP) in Pregnancy

Recombinant Human Thrombopoietin (rhTPO) in Management of Immune Thrombocytopenia (ITP)in Pregnancy: a Single-center Clinical Trial

This clinical trial is undertaking by Qilu Hospital of Shandong University, aims at evaluating efficacy and safety of rhTPO in management of ITP in pregnancy.

Study Overview

• Status: Unknown
• Conditions: Pregnancy; Immune Thrombocytopenia
• Intervention / Treatment: Drug: rhTPO

Detailed Description

The investigators are undertaking a single-center, non-randomized, non-controlled trial of 30 ITP patients in pregnancy from Qilu Hospital of Shandong University. ITP patients in pregnancy who failed to respond to prednisone, IVIG and developed refractoriness to platelet transfusion will be given rhTPO intravenously at a dose of 300U/kg every day. Dose will be tapered to 300U/kg every other day when platelet count rise over 50×10^9/L. Maintenance will be continued after delivery and the dose will be further reduced to 300U/kg per week. Platelet count, bleeding and other symptoms will be evaluated before and after treatment. Adverse events will be recorded throughout the study.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250012
      • Recruiting
      • Shandong University Qilu Hospital
      • Principal Investigator: Ming Hou
      • Contact: Ming Hou, MD PhD; Phone Number: 9879 +86-531-82169114; Email: houming@medmail.com.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Subject is between 18-50 years old.
2. After 12 weeks gestation.
3. Diagnosed with ITP meeting the diagnostic criteria for immune thrombocytopenia.
4. Patients who have no response or relapsed after Corticosteroid or IVIG.
5. Patients developed refractoriness to platelet transfusion.
6. To show a platelet count < 30×10^9/L, and with bleeding manifestations.
7. Willing and able to sign written informed consent.

Exclusion Criteria:

1. Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit.
2. Received second-line ITP-specific treatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) within 3 months before the screening visit.
3. Current HIV infection or hepatitis B virus or hepatitis C virus infections.
4. Severe medical condition (lung, hepatic or renal disorder) other than chronic ITP. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia)
5. Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test.
6. Patients who are deemed unsuitable for the study by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: rhTPO; rhTPO will be given intravenously at a dose of 300U/kg every day. Dose will be tapered to 300U/kg every other day when platelet count rise over 50×10^9/L. Maintenance will be continued after delivery and the dose will be further reduced to 300U/kg per week.	Drug: rhTPO; rhTPO will be given intravenously at a dose of 300U/kg every day. Dose will be tapered to 300U/kg every other day when platelet count rise over 50×10^9/L. Maintenance will be continued after delivery and the dose will be further reduced to 300U/kg per week.; Other Names: TPIAO; S20050048/49 (SFDA, China)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Early Response	Response rate (CR+R) at the 14th day, the 10th week from the initial injection of rhTPO, ante partum and one month after delivery. CR is defined as platelet count ≥ 100×109/L, and R is defined as platelet count of >30×109/L with at least a doubling of the baseline value.	one month after delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety	Adverse events in patients and infants.	six months after delivery

Collaborators and Investigators

• Sponsor: Shandong University
• Investigators: Principal Investigator: Ming Hou, MD PhD, Shandong University

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Anticipated): January 1, 2017
• Study Completion (Anticipated): April 1, 2017

Study Registration Dates

• First Submitted: October 17, 2014
• First Submitted That Met QC Criteria: October 17, 2014
• First Posted (Estimate): October 21, 2014

Study Record Updates

• Last Update Posted (Estimate): April 20, 2016
• Last Update Submitted That Met QC Criteria: April 18, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: pregnancy; immune thrombocytopenia; recombinant human thrombopoietin
• Additional Relevant MeSH Terms: Pathologic Processes; Immune System Diseases; Autoimmune Diseases; Hematologic Diseases; Hemorrhage; Hemorrhagic Disorders; Blood Coagulation Disorders; Skin Manifestations; Blood Platelet Disorders; Thrombotic Microangiopathies; Purpura, Thrombocytopenic; Purpura; Purpura, Thrombocytopenic, Idiopathic; Thrombocytopenia
• Other Study ID Numbers: rhTPO-ITP-Pregnancy