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

Phase 2

• Conditions: Immune Thrombocytopenia
• Interventions: Drug: Prednisone; Drug: Recombinant Human TPO

• Registration Number: NCT05333744
• Lead Sponsor: Peking University People's Hospital

Brief 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

Detailed Description

The investigators are undertaking a parallel group, randomized controlled trial of adults with ITP in pregnancy in China. Patients were randomized to prednisone plus rhTPO and prednisone monotherapy group. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.

Study Timeline

• Study Start: 2021-06-01
• Status Verified: 2022-04
• Study First Submitted: 2022-04-06
• Study First Submitted QC: 2022-04-17
• Last Update Submitted: 2022-04-17
• Study First Posted: 2022-04-19
• Last Update Posted: 2022-04-19
• Primary Completion: 2022-06-01
• Study Completion: 2022-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 90

Inclusion Criteria

1. Age 18-49;
2. Gestational weeks ≥20 weeks;
3. Platelet count <30×10^9/L, accompanied with or without bleeding symptoms;
4. Confirmed diagnosed, treatment-naive ITP in pregnancy;
5. Willing and able to sign written informed consent.

Exclusion Criteria

1. Secondary ITP such as drug-related thrombocytopenia;
2. Thrombocytopenia caused by viral infection (HIV, hepatitis B or hepatitis C); Other autoimmune diseases (including positive anti-nuclear antibodies, positive anti-cardiolipin antibodies, positive lupus anticoagulant factors, and positive Coombs) with severe heart, kidney, liver or respiratory dysfunction;
3. Severe immunodeficiency;
4. Myelodysplastic or myeloid fibrosis;
5. History of malignancy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prednisone plus rhTPO	Prednisone	Prednisone 20mg per day, 2 weeks and rhTPO 300U/kg per day, 2 weeks
Prednisone plus rhTPO	Recombinant Human TPO	Prednisone 20mg per day, 2 weeks and rhTPO 300U/kg per day, 2 weeks
Prednisone	Prednisone	Prednisone 20mg per day, 2 weeks

Primary Outcome Measures

Name	Time	Method
Response	day 14	Response (R) as platelet count more than 30,000 per cubic millimeter and at least 2-fold increase of the baseline count and absence of bleeding.
Platelet counts at delivery	At delivery	Platelet counts at delivery

Secondary Outcome Measures

Name	Time	Method
Number of patients with bleeding	During treatment（up to 6 weeks after delivery）	Number of patients with bleeding symptome
Number of patients with adverse events	During treatment（up to 6 weeks after delivery）	Number of patients with adverse events
Platelet counts of newborns	at delivery	Platelet counts of newborns
Number of newborns with adverse events	During treatment（up to 6 weeks after delivery）	Number of newborns with adverse events
Loss of response	During treatment（up to 6 weeks after delivery）	Platelet counts below 100 x 109/L or bleeding (from CR) or platelet counts below 30 x 109/L, less than 2-fold increase of baseline platelet count or bleeding (from R)

Trial Locations

Locations (1)

Peking University Insititute of Hematology, Peking University People's Hospital; 🇨🇳 Beijing, China