Clinical Trial: Efficacy and Safety of Romiplostim in Adult Subjects With Persistent or Chronic Immune Thrombocytopenia (ITP)
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Multi-center, Randomized, Placebo-controlled, Double-blinded Then Open 2 Stages Clinical Trial to Evaluate the Efficacy and Safety of Romiplostim in Adult Subjects With Persistent or Chronic Primary
Brief Summary: The objective is to evaluate the efficacy and safety of romiplostim for injection in adlut subjects with persistent or chronic primary immune thrombocytopenia (ITP).
Detailed Summary:
Sponsor: Kyowa Hakko Kirin China Pharmaceutical Co.,LTD.
Current Primary Outcome: Number of weeks in which the platelet response counts increase above 50×10^9/L [ Time Frame: 6 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Proportion of subjects whose platelet counts relative to the baseline increase ≥ 20×10^9/L [ Time Frame: 6 weeks ]
- Proportion of subjects who have received emergency treatment to increase the platelet counts [ Time Frame: 6 weeks ]
Original Secondary Outcome: Same as current
Information By: Kyowa Hakko Kirin China Pharmaceutical Co.,LTD.
Dates:
Date Received: August 11, 2016
Date Started: September 2015
Date Completion: December 2017
Last Updated: August 16, 2016
Last Verified: August 2016
