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

NCT02270801 | Unknown Phase 3 DMC

• 1 other identifier: rhTPO-ITP-Pregnancy
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Immune Thrombocytopenia; Pregnancy

Keywords

recombinant human thrombopoietin; immune thrombocytopenia; pregnancy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Safety

  six months after delivery

Study Arms (1)

rhTPO

EXPERIMENTAL

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

Interventions

rhTPO DRUG

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.

Also known as: TPIAO, S20050048/49 (SFDA, China)

rhTPO

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit.
• Received second-line ITP-specific treatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) within 3 months before the screening visit.
• Current HIV infection or hepatitis B virus or hepatitis C virus infections.
• 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)
• 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.
• Patients who are deemed unsuitable for the study by the investigator.

Sponsors & Collaborators

• Shandong University: lead

Study Sites (1)

Shandong University Qilu hospital

Jinan, Shandong, 250012, China

RECRUITING

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Condition Hierarchy (Ancestors)

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

Study Officials

• Ming Hou, MD PhD

  Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming Hou, MD PhD

CONTACT

86-531-82169114; houming@medmail.com.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: Professor and Director

Study Record Dates

• First Submitted: October 17, 2014
• First Posted: October 21, 2014
• Study Start: October 1, 2014
• Primary Completion: January 1, 2017
• Study Completion: April 1, 2017
• Last Updated: April 20, 2016

Record last verified: 2016-03

Locations

CN (1)