Immune Thrombocytopenia
Conditions
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.
Interventions
DRUGPrednisone
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.
DRUGRecombinant 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.
Sponsors
Peking University People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 49 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Platelet counts of newborns | at delivery | Platelet counts of newborns |
| Number of patients with bleeding | During treatment（up to 6 weeks after delivery） | Number of patients with bleeding symptome |
| 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) |
| Number of newborns with adverse events | During treatment（up to 6 weeks after delivery） | Number of newborns with adverse events |
| Number of patients with adverse events | During treatment（up to 6 weeks after delivery） | Number of patients with adverse events |
Countries
China
Contacts
Primary ContactXiao-hui Zhang, Professor
Backup ContactQi Chen, MD
Outcome results
None listed