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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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Boehringer Ingelheim

Status and phase

Terminated
Phase 1

Conditions

Purpura, Thrombocytopenic, Idiopathic

Treatments

Drug: BI 655064

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

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

Enrollment

6 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

6 participants in 1 patient group

BI 655064 120 mg / 180 mg
Experimental group
Description:
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.
Treatment:
Drug: BI 655064

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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