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The Combination of Prednisone and Recombinant Human Thrombopoietin for Treatment of Immune Thrombocytopenia in Pregnancy

NCT05333744 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2022-04-19

No results posted yet for this study

Summary

Randomized, open-label study to compare the efficacy and safety of prednisone plus recombinant human thrombopoietin (rhTPO) compared to prednisone monotherapy for the treatment of immune thrombocytopenia in pregnancy

Conditions

Interventions

DRUG

Prednisone

Prednisone po, 20mg per day for 2 weeks, if response (Plt 30-100×100\^g/L),gradually taper to the maintenance dose（5-10mg per day）until 6 weeks after delivery; if not response, gradually taper to withdrawal.

DRUG

Recombinant Human TPO

rhTPO im, 300U/kg per day for 2 weeks, if response (Plt 30-100×100\^g/L), taper to 300U/kg for twice per week until 6 weeks after delivery; if not response, drug withdrawal.

Sponsors & Collaborators

  • Peking University People's Hospital

    lead OTHER

Principal Investigators

  • Xiao-hui Zhang, Professor · Peking University People's Hospital, Peking University Insititute of Hematology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
49 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2022-06-01
Completion
2022-09-01

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
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 NCT05333744 on ClinicalTrials.gov