NCT00684476

Brief Summary

Maintenance venom immunotherapy administered at 6-month intervals to bee-venom allergic patients failed to provide protection from systemic reactions after sting challenges. These patients should continue their immunotherapy at 1-3 month intervals.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2004

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2006

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

May 21, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 26, 2008

Completed
Last Updated

May 26, 2008

Status Verified

March 1, 2004

First QC Date

May 21, 2008

Last Update Submit

May 23, 2008

Conditions

Venom Allergy

Outcome Measures

Primary Outcomes (3)

  • whether the administration of bee venom (BV)

  • maintenance dose (MD) at 6-month interval is safe and

  • efficacious.

Interventions

venom immunotherapyDRUG

Eligibility Criteria

Age6 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Venom allergy

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Venom Hypersensitivity

Interventions

Desensitization, Immunologic

Condition Hierarchy (Ancestors)

Hypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Immunosuppression TherapyImmunotherapyImmunomodulationBiological TherapyTherapeuticsImmunologic TechniquesInvestigative Techniques

Study Officials

  • Arnon Goldberg, M.D

    The Allergy and Clinical Immunology Unit, Meir Hospital, Kfar-Saba, Israel, affiliated with The Sackler School of Medicine, Tel-Aviv University, Tel-Aviv, Israel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 21, 2008

First Posted

May 26, 2008

Study Start

June 1, 2004

Study Completion

May 1, 2006

Last Updated

May 26, 2008

Record last verified: 2004-03