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Recombinant Human Thrombopoietin(rhTPO) in Pregnancy With Immune Thrombocytopenia

NCT03492515 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2018-04-10

No results posted yet for this study

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

Interventions

DRUG

recombinant human thrombopoietin

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.

DRUG

Platelet Concentrate

according to the their conditions, use if necessary

Sponsors & Collaborators

  • Peking University People's Hospital

    collaborator OTHER

  • First Affiliated Hospital of Chongqing Medical University

    collaborator OTHER

  • Linyi People's Hospital

    collaborator OTHER

  • The Affiliated Hospital of Qingdao University

    collaborator OTHER

  • Shandong Provincial Hospital

    collaborator OTHER_GOV

  • Zhongshan Bo Ai Hospital

    collaborator OTHER

  • Shandong University

    lead OTHER

Principal Investigators

  • Ming Hou,, Dr · Shandong University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-01
Primary Completion
2020-05-01
Completion
2022-05-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03492515 on ClinicalTrials.gov