Back to resultsMultiple Rising Does Study (Subcutaneous Doses) of BI 655064 in Male and Female Patients With Chronic Primary Immune Thrombocytopenic Purpura (ITP).
Primary Purpose
Purpura, Thrombocytopenic, Idiopathic
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
BI 655064
Sponsored by
About this trial
This is an interventional treatment trial for Purpura, Thrombocytopenic, Idiopathic
Eligibility Criteria
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)
Sites / Locations
- 1293.7.10002 Boehringer Ingelheim Investigational Site
- 1293.7.10001 Boehringer Ingelheim Investigational Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
BI 655064 subcutaneous
Arm Description
Escalating single dose as subcutaneous injection
Outcomes
Primary Outcome Measures
The primary efficacy endpoint is the number of patients with response in platelet count
Secondary Outcome Measures
Number of subjects with drug-related adverse events
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
Full Information
NCT ID
NCT02009761
First Posted
December 9, 2013
Last Updated
September 28, 2016
Sponsor
Boehringer Ingelheim
1. Study Identification
Unique Protocol Identification Number
NCT02009761
Brief Title
Multiple Rising Does Study (Subcutaneous Doses) of BI 655064 in Male and Female Patients With Chronic Primary Immune Thrombocytopenic Purpura (ITP).
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.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2016
Overall Recruitment Status
Terminated
Study Start Date
December 2013 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
5. Study Description
Brief Summary
BI 655064 will be administered subcutaneously once weekly in patients with immune thrombocytopenic purpura (ITP) for up to 12 weeks.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Purpura, Thrombocytopenic, Idiopathic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BI 655064 subcutaneous
Arm Type
Experimental
Arm Description
Escalating single dose as subcutaneous injection
Intervention Type
Drug
Intervention Name(s)
BI 655064
Intervention Description
subcutaneous injection
Primary Outcome Measure Information:
Title
The primary efficacy endpoint is the number of patients with response in platelet count
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Number of subjects with drug-related adverse events
Time Frame
18 weeks
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Organizational Affiliation
Boehringer Ingelheim
Official's Role
Study Chair
Facility Information:
Facility Name
1293.7.10002 Boehringer Ingelheim Investigational Site
City
Los Angeles
State/Province
California
Country
United States
Facility Name
1293.7.10001 Boehringer Ingelheim Investigational Site
City
New York
State/Province
New York
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Multiple Rising Does Study (Subcutaneous Doses) of BI 655064 in Male and Female Patients With Chronic Primary Immune Thrombocytopenic Purpura (ITP).
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