IVIg Plus Low Dose rhTPO for ITP in Pregnancy

NCT05634824 | Unknown Phase 2

• 1 other identifier: PKU-ITP022
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

Randomized, open-label, multicenter study to investigate the efficacy and safety of IVIg plus low-dose recombinant thrombopoietin in pregnant patients with corticosteroid or IVIg monotherapy-resistant ITP.

Conditions

Immune Thrombocytopenia; Pregnancy Related

Keywords

immune thrombocytopenia; pregnancy related

Outcome Measures

Primary Outcomes (1)

• 4-week response rate

  4 weeks

Secondary Outcomes (5)

• Time to relapse

  13 months

• Bleeding manifestations

  13 months

• Additional ITP therapy

  13 months

• Maternal and neonatal adverse events

  13 months

• Neonatal platelet count

  up to 34 weeks

Study Arms (2)

IVIg plus low dose rhTPO

EXPERIMENTAL

Patients were randomized into experimental and control groups. For the experimental patients, the initial combination therapy consisted rhTPO at an initial does of 150U/kg once daily subcutaneously for 28 days and IVIg 400mg/kg per day for 5 days. If the platelet count was in the range of 30 to 50 × 10\^9/L, the combination therapy was repeated. To reduce the risk for thrombocytosis, patients received maintenance therapy consisting rhTPO at a dose of 150U/kg per day if the platelet count rose above 50 × 10\^9/L, and treatment discontinued when platelet counts exceeded 100 × 10\^9/L. After delivery, the treatment consisted rhTPO 150U/kg per day, and maintained the dose if the platelet count exceeded 30 × 10\^9/L. In addition, IVIg 400mg/kg per day for 5 days was added if the platelet count could not maintain above 30 × 10\^9/L. If patients did not achieve 30 × 10\^9/L within 4 weeks treatment was also discontinued.

Drug: intravenous immunoglobulin plus low dose recombinant human thrombopoietin (rhTPO)

IvIg treatment

ACTIVE COMPARATOR

Patients would be treated with IVIg 400mg/kg per day for 5 days monthly. And treatment discontinued when platelet counts exceeded 100 × 10\^9/L.

Drug: intravenous immunoglobulin

Interventions

intravenous immunoglobulin plus low dose recombinant human thrombopoietin (rhTPO) DRUG

rhTPO at an initial does of 150U/kg qd subcutaneously for 28 days and IVIg 400mg/kg qd for 5 days. The maintenance treatment consisted rhTPO 150U/kg qd.

IVIg plus low dose rhTPO

intravenous immunoglobulin DRUG

intravenous immunoglobulin

IvIg treatment

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: The study focuses on Pregnancy ITP, the gender of which is female.
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients have a diagnosis of primary ITP before or first onset during pregnancy; Patients ≥ 18 years; patients complicate with bleeding manifestations and/or have a platelet count \< 30 × 10\^9/L and failed to respond to initial treatment of corticosteroids or intravenous immunoglobulin (IVIg) monotherapy or relapsed during the tapering or discontinuation of corticosteroids.

You may not qualify if:

• Patients whose thrombocytopenia was secondary to cancer (solid tumor or leukemia), infections, preeclampsia, and HELLP syndrome (hemolysis, elevated liver enzymes, low platelets), and those who had primary immune deficiency, and other hematology or connective tissue diseases during follow-up; patients have heart, kidney, liver, or lung dysfunction; patients received chemotherapy or anticoagulants within 3 months before screening or other second-line ITP-specific treatments within 3 months before screening.

Sponsors & Collaborators

• Peking University People's Hospital: lead

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

Immunoglobulins, Intravenous; 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)

Immunoglobulin G; Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Biological Factors

Central Study Contacts

Xiao-Hui Zhang, Prof.

CONTACT

+8613522338836; zhangxh100@sina.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Peking University People's Hospital

Study Record Dates

• First Submitted: November 23, 2022
• First Posted: December 2, 2022
• Study Start: January 1, 2023
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: December 2, 2022

Record last verified: 2022-11