Multiple Rising Does Study (Subcutaneous Doses) of BI 655064 in Male and Female Patients With Chronic Primary Immune Thrombocytopenic Purpura (ITP).

Purpura, Thrombocytopenic, Idiopathic Clinical Trial

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 Chronic Primary Immune Thrombocytopenic Purpura.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02009761
• Other study ID #: 1293.7
• Status: Terminated
• Phase: Phase 1
• Start date: December 18, 2013
• Est. completion date: April 26, 2016

Study information

• Verified date: August 2023
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

BI 655064 will be administered subcutaneously once weekly in patients with immune thrombocytopenic purpura (ITP) for up to 12 weeks.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: April 26, 2016
• Est. primary completion date: April 26, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

Male and female chronic immune ITP patients

Exclusion criteria:

Any treatment of ITP excluded except for a stable dose of corticosteroids (up to 20 mg)

Related Conditions & MeSH terms

• Purpura
• Purpura, Thrombocytopenic
• Purpura, Thrombocytopenic, Idiopathic

Intervention

Drug:
• BI 655064
subcutaneous injection

Locations

Country	Name	City	State
United States	University of Southern California	Los Angeles	California
United States	New York Hospital, Cornell Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Patients With Response in Platelet Count	This outcome measure presents number of patients with a response in platelet count. Response was defined as: [A] An increase in platelet count by greater than 20 x 10^9/L from baseline at any time-point between Week 1 and Week 12, and [B] Platelet count above 50 x 10^9/L at any time point between Week 1 and Week 12 with no rescue therapy.; Baseline was defined as the platelet count at Visit 2 before administration of BI 655064. In case the patient fulfilled only one of the conditions, he/she was considered a non-responder.	Up to 12 weeks.
Secondary	Number of Subjects With Drug-related Adverse Events	Number of participants with investigator defined drug-related adverse events (AEs) is reported.	From first drug administration until end of the Residual Effect Period (REP), up to 6 weeks.
Secondary	Number of Patients Reaching the Cut-off Point for Immune Thrombocytopenic Purpura [ITP]	This outcome measure presents the number of patients reaching the cut-off point for ITP, which was defined as: [A] Platelet count = 100 x 10^9/L at any time point between Week 1 and Week 12.	Up to 12 weeks.

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