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

Sponsor

Peking University People's Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05333744

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
Immune Thrombocytopenia	Drug: Prednisone Drug: Recombinant Human TPO	Phase 2

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 Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 1, 2021

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Sep 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Prednisone plus rhTPO Prednisone 20mg per day, 2 weeks and rhTPO 300U/kg per day, 2 weeks	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. Other Names: rhTPO
Active Comparator: Prednisone Prednisone 20mg per day, 2 weeks	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.

Arm

Intervention/Treatment

Experimental: Prednisone plus rhTPO

Prednisone 20mg per day, 2 weeks and rhTPO 300U/kg per day, 2 weeks

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.

Other Names:

rhTPO

Active Comparator: Prednisone

Prednisone 20mg per day, 2 weeks

Drug: Prednisone

Outcome Measures

Primary Outcome Measures

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

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 49 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking University Insititute of Hematology, Peking University People's Hospital	Beijing		China

Sponsors and Collaborators

Peking University People's Hospital

Investigators

Principal Investigator: Xiao-hui Zhang, Professor, Peking University People's Hospital, Peking University Insititute of Hematology

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Xiao Hui Zhang, Vice president of Peking Univeristy Institute of Hematology, Peking University People's Hospital

ClinicalTrials.gov Identifier:

NCT05333744

Other Study ID Numbers:

ITP-PKU2204

First Posted:

Apr 19, 2022

Last Update Posted:

Apr 19, 2022

Last Verified:

Apr 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Thrombocytopenia

Purpura, Thrombocytopenic, Idiopathic

Prednisone

Study Results

No Results Posted as of Apr 19, 2022