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

NCT02009761 | Terminated Phase 1 Results

• 1 other identifier: 1293.7
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Purpura, Thrombocytopenic, Idiopathic

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Number of Subjects With Drug-related Adverse Events

  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]

  Up to 12 weeks.

Study Arms (1)

BI 655064 120 mg / 180 mg

EXPERIMENTAL

The patients were administered 120 mg BI 655064 solution for subcutaneous injection q1w (once a week) subcutaneously for 4 weeks. Patients who showed an increase in platelet count above or equal to 100 x 10\^9/L continued treatment with 120 mg BI 655064 solution for subcutaneous injection q1w for additional 8 weeks, followed by 12 weeks of follow-up. Patients whose platelet count stayed below 100 x 10\^9/L continued treatment for 2 weeks with 180 mg BI 655064 solution for subcutaneous injection q1w followed by 120 mg BI 655064 solution for subcutaneous injection q1w for additional 6 weeks, followed by 12 weeks of follow-up.

Drug: BI 655064

Interventions

BI 655064 DRUG

subcutaneous injection

BI 655064 120 mg / 180 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female chronic immune ITP patients

You may not qualify if:

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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (2)

University of Southern California

Los Angeles, California, 90033, United States

Location

New York Hospital, Cornell Medical Center

New York, New York, 10021, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Purpura, Thrombocytopenic, Idiopathic

Interventions

BI 655064

Condition Hierarchy (Ancestors)

Purpura, Thrombocytopenic; Purpura; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Thrombotic Microangiopathies; Thrombocytopenia; Blood Platelet Disorders; Cytopenia; Hemorrhagic Disorders; Autoimmune Diseases; Immune System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Skin Manifestations; Signs and Symptoms

Limitations and Caveats

Trial enrollment was permanently stopped due to low patient enrollment. At the time of termination of enrollment, only 6 patients were entered (only 2 of them completed treatment).

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2013
• First Posted: December 12, 2013
• Study Start: December 18, 2013
• Primary Completion: April 26, 2016
• Study Completion: April 26, 2016
• Last Updated: March 15, 2024
• Results First Posted: March 15, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)