Prednisone Plus IVIg vs. Prednisone for ITP During Pregnancy

Last updated: August 27, 2024
Sponsor: Peking University People's Hospital
Overall Status: Active - Recruiting

Phase

2

Condition

Thrombosis

Dysfunctional Uterine Bleeding

Immune (Idiopathic) Thrombocytopenic Purpura (Itp)

Treatment

IVIg

Prednisone

Clinical Study ID

NCT06577909
PKU-ITP023
  • Ages 18-50
  • Female

Study Summary

This is a prospective, randomized, open-label, multicenter clinical trial study to compare the efficacy and safety of prednisone plus IVIg to prednisone monotherapy in the treatment of immune thrombocytopenia (ITP) in pregnancy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 18-50 years old;

  2. Meet the diagnostic criteria for immune thrombocytopenia;

  3. Pregnant women with ITP without ITP-specific treatments during pregnancy;

  4. Gestational weeks ≥12 weeks;

  5. Platelet count <30×10^9/L, accompanied with or without bleeding symptoms.

  6. Willing and able to sign written informed consent.

Exclusion

Exclusion Criteria:

  1. Have a known diagnosis of other autoimmune diseases, confirmed medical history orlaboratory findings within positive anti-nuclear antibodies (>1:80),anti-cardiolipin antibodies, lupus anticoagulant factors or direct Coombs' test.

  2. Thrombocytopenia caused by pregnancy-specific conditions, such as gestationalthrombocytopenia, preeclampsia, the HELLP syndrome and acute fatty liver ofpregnancy.

  3. Secondary thrombocytopenia such as drug-related thrombocytopenia, vaccine-relatedthrombocytopenia, lymphoproliferative disorders, severe infection, hepatic cirrhosisand so on.

  4. With other underlying diseases that may cause thrombocytopenia, such as: malignantdisease, megaloblastic anemia, aplastic anemia, myelodysplasia syndrome, myeloidfibrosis, disseminated intravascular coagulation, thrombotic thrombocytopenicpurpura, Hemolytic uremic syndrome, disseminated intravascular coagulation and soon;

  5. Current HIV infection or hepatitis B virus or hepatitis C virus infections;

  6. With severe heart, kidney, liver or respiratory dysfunction;

  7. With the medical history of mental illness;

  8. Have allergic reaction to prednisone or IVIg;

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: IVIg
Phase: 2
Study Start date:
October 19, 2023
Estimated Completion Date:
December 31, 2025

Study Description

The investigators are undertaking a prospective, parallel group, multicenter, randomized controlled trial in pregnant patients with treat-naive ITP. A total of 100 participants are randomized to two groups with the 1:1 ratio: prednisone plus IVIg group versus prednisone monotherapy group. Participants will receive prednisone 20mg per day for 4 weeks plus IVIg 400mg/Kg (total dose ≤20g per day) for 5 days or prednisone 20mg monotherapy per day for 4 weeks. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Time to response and platelet counts of newborns are investigated. Adverse events including participants and their newborns are also recorded throughout and after the study.

Connect with a study center

  • Peking University Insititute of Hematology, Peking University People's Hospital

    Beijing, Beijing 100010
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.