Recombinant Human Thrombopoietin(rhTPO) in Pregnancy With Immune Thrombocytopenia

NCT03492515 | Unknown Phase 3 DMC

• 1 other identifier: rhTPO in pregnancy of ITP
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study was to observe the clinical efficacy and adverse reactions of rhTPO in the treatment of pregnancy-induced thrombocytopenia.

Conditions

Immune Thrombocytopenia

Keywords

immune thrombocytopenia

Outcome Measures

Primary Outcomes (1)

• Platelet count during delivery

  Platelet count during delivery will be assessed

  up to 2 years per subject

Secondary Outcomes (3)

• Adverse events in neonates

  up to 2 years per subject

• platlet count of newborns

  up to 42 days per newborn

• Adverse events in parturients

  up to 2 years per subject

Study Arms (3)

experimental group

EXPERIMENTAL

Accepting the treatment of rhTPO according platelet and bleeding condition

Drug: recombinant human thrombopoietin

non-administered group

ACTIVE COMPARATOR

No rhTPO will be used. If necessary, the patients will be given transfusion of platelets according to the their conditions.

Drug: Platelet Concentrate

healthy control group

NO INTERVENTION

Healthy pregnant women and no use of any medicine。

Interventions

recombinant human thrombopoietin DRUG

If platelet count \<30×10\^9/L and with haemorrhage or risk of bleeding,the patients began to receive subcutaneous injection of TPO with the dose of 300 Unit/kg qd,duration ≤14 days;If platelet count is between 30×10\^9/L and 50×10\^9/L, the dose will be 300 Unit/kg qod;If platlet count ≥100×109/L, stop this treatment;After delivery, if platelet count \<30×10\^9/L and with haemorrhage or risk of bleeding,subcutaneous injection of TPO with the dose of 300 Unit/kg qd or qod will be given at a duration ≤14 days;If platelet count is between 30×10\^9/L and 50×10\^9/L, the dose will be 300 Unit/kg qw;If platlet count ≥100×109/L, stop the treatment.

Also known as: rhTPO

experimental group

Platelet Concentrate DRUG

according to the their conditions, use if necessary

non-administered group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Meet the diagnostic criteria for immune thrombocytopenia.
• years of age; gestational age over 32 weeks;
• No response to the treatment of glucocorticoids and / or intravenous immunoglobulin (a stable dose of glucocorticoid could be accepted);
• Platelet transfusion was not effective.
• Platlet count of the patients \<30\* 10\^9/L and had the risk of bleeding or bleeding.
• No obvious abnormalities in liver and kidney function had (1.5 times higher than normal limit of the serum urea nitrogen, creatinine, serum transaminase and bilirubin );
• No severe cardiac and pulmonary dysfunction;
• No history of mental illness;
• Voluntarily signed written informed consent.

You may not qualify if:

• A history of serious allergies to biologics;
• The history of thrombosis;
• Thromboembolic or hemorrhagic disease;
• Patients who are deemed unsuitable for the study by the investigator.

Sponsors & Collaborators

• Shandong University: lead
• Peking University People's Hospital: collaborator
• First Affiliated Hospital of Chongqing Medical University: collaborator
• Linyi People's Hospital: collaborator
• The Affiliated Hospital of Qingdao University: collaborator
• Shandong Provincial Hospital: collaborator
• Zhongshan Bo Ai Hospital: collaborator

Study Sites (1)

Qilu hospital, Shandong University

Jinan, Shandong, 250012, China

Location

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

Thrombopoietin

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

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

• Ming Hou,, Dr

  Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming Hou, Dr

CONTACT

+86-531-82169114; houming@medmail.com.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Director

Study Record Dates

• First Submitted: March 26, 2018
• First Posted: April 10, 2018
• Study Start: May 1, 2018
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2022
• Last Updated: April 10, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)