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

Phase 1TerminatedNCT02009761

Boehringer Ingelheim6 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

BI 655064DRUG

subcutaneous injection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (2)

University of Southern California

Los Angeles, California, United States

New York Hospital, Cornell Medical Center

New York, New York, United States

Outcomes

Primary Outcomes

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.

Time frame: Up to 12 weeks.

Secondary Outcomes

Number of Subjects With Drug-related Adverse Events

Number of participants with investigator defined drug-related adverse events (AEs) is reported.

Time frame: From first drug administration until end of the Residual Effect Period (REP), up to 6 weeks.

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.

Time frame: Up to 12 weeks.

Data from ClinicalTrials.gov

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