An observational case series of the use of anti-Immunoglobulin E antibody for the management of treatment-resistant systemic mastocytosis.

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000886280

Enrollment

Registered

2009-10-12

Start date

2009-11-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The primary purpose of the study is to observe the effect of anti-immunoglobulin E antibody in the treatment of a small number of people with symptomatic mastocytosis.

Interventions

Anti-immunoglobulin E antibody will be administered to participants as a subcutaneous injection, at a dose of 375mg (which may be altered during the course of treatment, depending on individual patient response), every fortnight, for a total of 24 weeks, equivalent to twelve doses.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Adults with symptomatic systemic mastocytosis that is resistant to other conventional therapies

Exclusion criteria

Associated haematological clonal non-mast cell lineage disease or mast cell leukaemia; Pregnancy.

Outcome results