Back to resultsThe Combination of Prednisone and Recombinant Human Thrombopoietin for Treatment of Immune Thrombocytopenia in Pregnancy
Primary Purpose
Immune Thrombocytopenia
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Prednisone
Recombinant Human TPO
Sponsored by
About this trial
This is an interventional treatment trial for Immune Thrombocytopenia
Eligibility Criteria
Inclusion Criteria:
- Age 18-49;
- Gestational weeks ≥20 weeks;
- Platelet count <30×10^9/L, accompanied with or without bleeding symptoms;
- Confirmed diagnosed, treatment-naive ITP in pregnancy;
- Willing and able to sign written informed consent.
Exclusion Criteria:
- Secondary ITP such as drug-related thrombocytopenia;
- 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;
- Severe immunodeficiency;
- Myelodysplastic or myeloid fibrosis;
- History of malignancy.
Sites / Locations
- Peking University Insititute of Hematology, Peking University People's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Prednisone plus rhTPO
Prednisone
Arm Description
Prednisone 20mg per day, 2 weeks and rhTPO 300U/kg per day, 2 weeks
Prednisone 20mg per day, 2 weeks
Outcomes
Primary Outcome Measures
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.
Platelet counts at delivery
Platelet counts at delivery
Secondary Outcome Measures
Number of patients with bleeding
Number of patients with bleeding symptome
Number of patients with adverse events
Number of patients with adverse events
Platelet counts of newborns
Platelet counts of newborns
Number of newborns with adverse events
Number of newborns with adverse events
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)
Full Information
NCT ID
NCT05333744
First Posted
April 6, 2022
Last Updated
April 17, 2022
Sponsor
Peking University People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05333744
Brief Title
The Combination of Prednisone and Recombinant Human Thrombopoietin for Treatment of Immune Thrombocytopenia in Pregnancy
Official Title
The Combination of Prednisone and Recombinant Human Thrombopoietin vs Prednisone Monotherapy for Treatment in Immune Thrombocytopenia in Pregnancy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
June 1, 2022 (Anticipated)
Study Completion Date
September 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune Thrombocytopenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Prednisone plus rhTPO
Arm Type
Experimental
Arm Description
Prednisone 20mg per day, 2 weeks and rhTPO 300U/kg per day, 2 weeks
Arm Title
Prednisone
Arm Type
Active Comparator
Arm Description
Prednisone 20mg per day, 2 weeks
Intervention Type
Drug
Intervention Name(s)
Prednisone
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Recombinant Human TPO
Other Intervention Name(s)
rhTPO
Intervention Description
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.
Primary Outcome Measure Information:
Title
Response
Description
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.
Time Frame
day 14
Title
Platelet counts at delivery
Description
Platelet counts at delivery
Time Frame
At delivery
Secondary Outcome Measure Information:
Title
Number of patients with bleeding
Description
Number of patients with bleeding symptome
Time Frame
During treatment（up to 6 weeks after delivery）
Title
Number of patients with adverse events
Description
Number of patients with adverse events
Time Frame
During treatment（up to 6 weeks after delivery）
Title
Platelet counts of newborns
Description
Platelet counts of newborns
Time Frame
at delivery
Title
Number of newborns with adverse events
Description
Number of newborns with adverse events
Time Frame
During treatment（up to 6 weeks after delivery）
Title
Loss of response
Description
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)
Time Frame
During treatment（up to 6 weeks after delivery）
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18-49;
Gestational weeks ≥20 weeks;
Platelet count <30×10^9/L, accompanied with or without bleeding symptoms;
Confirmed diagnosed, treatment-naive ITP in pregnancy;
Willing and able to sign written informed consent.
Exclusion Criteria:
Secondary ITP such as drug-related thrombocytopenia;
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;
Severe immunodeficiency;
Myelodysplastic or myeloid fibrosis;
History of malignancy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xiao-hui Zhang, Professor
Phone
+8613522338836
Email
zhangxh100@sina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Qi Chen, MD
Phone
+8618515983660
Email
cq9303@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiao-hui Zhang, Professor
Organizational Affiliation
Peking University People's Hospital, Peking University Insititute of Hematology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Peking University Insititute of Hematology, Peking University People's Hospital
City
Beijing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiao-hui Zhang, Professor
Email
zhangxh100@sina.com
12. IPD Sharing Statement
Learn more about this trial
The Combination of Prednisone and Recombinant Human Thrombopoietin for Treatment of Immune Thrombocytopenia in Pregnancy
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