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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2022-09-01

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Immune Thrombocytopenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Prednisone plus rhTPO

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

Group Type EXPERIMENTAL

Prednisone

Intervention Type 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.

Recombinant Human TPO

Intervention Type 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.

Prednisone

Prednisone 20mg per day, 2 weeks

Group Type ACTIVE_COMPARATOR

Prednisone

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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rhTPO

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No