A Multicenter Study on Recombinant Human Thrombopoietin in Management of ITP in Pregnancy
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|ClinicalTrials.gov Identifier: NCT02391272|
Recruitment Status : Completed
First Posted : March 18, 2015
Last Update Posted : March 20, 2020
|Condition or disease||Intervention/treatment||Phase|
|Immune Thrombocytopenia Pregnancy||Drug: rhTPO||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter Open-labeled Pilot Study on Recombinant Human Thrombopoietin in Management of Immune Thrombocytopenia in Pregnancy|
|Study Start Date :||March 2015|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||June 2016|
rhTPO will be given 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.
Other Name: TPIAO
- Early response 1- Response rate (CR+R) [ Time Frame: 7th day ]Response rate (CR+R) at the 7th day. CR is defined as platelet count ≥ 100×10^9/L, and R is defined as platelet count of >30×10^9/L with at least a doubling of the baseline value.
- Early response 2- Response rate (CR+R) [ Time Frame: 14th day ]Response rate (CR+R) at the 14th day.
- Long-time response 1 (Platelet count) [ Time Frame: 10th week ]Platelet count at 10th week.
- Long-time response 2 (Platelet count) [ Time Frame: 40 weeks' gestation ]Platelet count at 40 weeks' gestation.
- Long-time response 3 (Platelet count) [ Time Frame: one month after delivery ]Platelet count one month after delivery.
- Safety (Adverse events) [ Time Frame: 6 months after delivery ]Adverse events in patients and infants.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02391272
|Qilu Hospital, Shandong University|
|Jinan, Shandong, China|
|Principal Investigator:||Ming Hou, MD PhD||Shandong University Qilu hospital|