Trials / Completed
CompletedNCT02391272
A Multicenter Study on Recombinant Human Thrombopoietin in Management of ITP in Pregnancy
A Multicenter Open-labeled Pilot Study on Recombinant Human Thrombopoietin in Management of Immune Thrombocytopenia in Pregnancy
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 31 (actual)
- Sponsor
- Shandong University · Academic / Other
- Sex
- Female
- Age
- 18 Years – 50 Years
- Healthy volunteers
- Not accepted
Summary
The project was undertaking by Qilu Hospital of Shandong University and other well-known hospitals in China. Aims at evaluating efficacy and safety of rhTPO in management of ITP in pregnancy.
Detailed description
The investigators are undertaking a multicenter, open-labeled, pilot study of 30 ITP patients in pregnancy from Qilu Hospital of Shandong University and other well-known hospitals in China. ITP patients in pregnancy who failed to respond to prednisone, IVIG and developed refractoriness to platelet transfusion will be given rhTPO intravenously at a dose of 300U/kg every day. Dose will be tapered to 300U/kg every other day when platelet count rise over 50×10\^9/L. Maintenance will be continued after delivery and the dose will be further reduced to 300U/kg per week. Platelet count, bleeding and other symptoms will be evaluated before and after treatment. Adverse events will be recorded throughout the study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | rhTPO |
Timeline
- Start date
- 2015-03-01
- Primary completion
- 2015-11-01
- Completion
- 2016-06-01
- First posted
- 2015-03-18
- Last updated
- 2020-03-20
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT02391272. Inclusion in this directory is not an endorsement.