Clinical Trial: Multiple Rising Does Study (Subcutaneous Doses) of BI 655064 in Male and Female Patients With Chronic Primary Immune Thrombocytopenic Purpura (ITP).
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Safety, Efficacy, Tolerability, Pharmacokinetics and Pharmacodynamics of Open Label Study With Multiple (and for Non Responders) Escalating Subcutaneous Doses of BI 655064 Once a Week in Patients With
Brief Summary: BI 655064 will be administered subcutaneously once weekly in patients with immune thrombocytopenic purpura (ITP) for up to 12 weeks.
Detailed Summary:
Sponsor: Boehringer Ingelheim
Current Primary Outcome: The primary efficacy endpoint is the number of patients with response in platelet count [ Time Frame: 12 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Number of subjects with drug-related adverse events [ Time Frame: 18 weeks ]
- The secondary endpoint is the number of patients reaching the cut off point for ITP, which is defined as platelet count >= 100 x 10^9/L at any visit [ Time Frame: 12 weeks ]
Original Secondary Outcome:
- Number of subjects with drug-related adverse events [ Time Frame: 18 weeks ]
- The secondary endpoint is the number of patients reaching the cut off point for ITP, which is defined as platelet count greater than or equal to 100,000 at any visit [ Time Frame: 12 weeks ]
Information By: Boehringer Ingelheim
Dates:
Date Received: December 9, 2013
Date Started: December 2013
Date Completion:
Last Updated: September 28, 2016
Last Verified: September 2016
