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

NCT05333744 | Unknown Phase 2

• 1 other identifier: ITP-PKU2204
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Conditions

Immune Thrombocytopenia

Outcome Measures

Primary Outcomes (2)

• 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

• Platelet counts at delivery

  Platelet counts at delivery

  At delivery

Secondary Outcomes (5)

• Number of patients with bleeding

  During treatment（up to 6 weeks after delivery）

• Number of patients with adverse events

  During treatment（up to 6 weeks after delivery）

• Platelet counts of newborns

  at delivery

• Number of newborns with adverse events

  During treatment（up to 6 weeks after delivery）

• Loss of response

  During treatment（up to 6 weeks after delivery）

Study Arms (2)

Prednisone plus rhTPO

EXPERIMENTAL

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

Drug: Prednisone; Drug: Recombinant Human TPO

Prednisone

ACTIVE COMPARATOR

Prednisone 20mg per day, 2 weeks

Drug: Prednisone

Interventions

Prednisone DRUG

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.

Prednisone; Prednisone plus rhTPO

Recombinant Human TPO DRUG

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.

Also known as: rhTPO

Prednisone plus rhTPO

Eligibility Criteria

• Age: 18 Years - 49 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

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

Beijing, China

RECRUITING

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

Prednisone; Thrombopoietin

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Xiao-hui Zhang, Professor

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiao-hui Zhang, Professor

CONTACT

+8613522338836; zhangxh100@sina.com

Qi Chen, MD

CONTACT

+8618515983660; cq9303@sina.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice president of Peking Univeristy Institute of Hematology

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: April 19, 2022
• Study Start: June 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: September 1, 2022
• Last Updated: April 19, 2022

Record last verified: 2022-04

Locations

CN (1)