NCT00263926

Brief Summary

The trial is performed to assess efficacy and safety of a purified standardised wasp venom preparation in wasp venom allergy

Trial Health

87
On Track

Trial Health Score

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

Timeline
Completed

Started Mar 2001

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

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

March 1, 2001

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

December 9, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 12, 2005

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
3.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

March 11, 2013

Status Verified

March 1, 2013

Enrollment Period

6.2 years

First QC Date

December 9, 2005

Last Update Submit

March 8, 2013

Conditions

Allergy

Keywords

Wasp venom allergy,specific immunotherapy

Interventions

wasp venomBIOLOGICAL

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • History of wasp venom allergy,
  • Positive RAST to wasp venom,
  • Positive skin prick test to wasp venom

You may not qualify if:

  • Serious chronic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Allergopharma GmbH & Co. KG

Reinbek, 21465, Germany

Location

Related Links

MeSH Terms

Conditions

HypersensitivityVenom Hypersensitivity

Interventions

Wasp Venoms

Condition Hierarchy (Ancestors)

Immune System DiseasesHypersensitivity, Immediate

Intervention Hierarchy (Ancestors)

Arthropod VenomsVenomsComplex MixturesToxins, BiologicalBiological Factors

Study Officials

  • Annemie Narkus, M.D.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2005

First Posted

December 12, 2005

Study Start

March 1, 2001

Primary Completion

May 1, 2007

Study Completion

November 1, 2010

Last Updated

March 11, 2013

Record last verified: 2013-03

Locations

DE(1)