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

Immune Thrombocytopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05333744
• Other study ID #: ITP-PKU2204
• Status: Recruiting
• Phase: Phase 2
• Start date: June 1, 2021
• Est. completion date: September 1, 2022

Study information

• Verified date: April 2022
• Source: Peking University People's Hospital
• Contact: Xiao-hui Zhang, Professor
• Phone: +8613522338836
• Email: zhangxh100[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: September 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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.

Related Conditions & MeSH terms

• Immune Thrombocytopenia
• Purpura, Thrombocytopenic, Idiopathic
• Thrombocytopenia

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Peking University Insititute of Hematology, Peking University People's Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response	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.	day 14
Primary	Platelet counts at delivery	Platelet counts at delivery	At delivery
Secondary	Number of patients with bleeding	Number of patients with bleeding symptome	During treatment(up to 6 weeks after delivery)
Secondary	Number of patients with adverse events	Number of patients with adverse events	During treatment(up to 6 weeks after delivery)
Secondary	Platelet counts of newborns	Platelet counts of newborns	at delivery
Secondary	Number of newborns with adverse events	Number of newborns with adverse events	During treatment(up to 6 weeks after delivery)
Secondary	Loss of response	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)	During treatment(up to 6 weeks after delivery)