NCT00554983

Brief Summary

Efficacy and Safety from a recombinant folding variant of Bet v 1

Trial Health

87
On Track

Trial Health Score

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

Enrollment
255

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Sep 2007

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

September 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 6, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 7, 2007

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

November 8, 2013

Status Verified

November 1, 2013

Enrollment Period

2.8 years

First QC Date

November 6, 2007

Last Update Submit

November 7, 2013

Conditions

Allergy

Keywords

Recombinant birch pollen allergyIgE-mediated allergic disease attributed to birch pollen

Outcome Measures

Primary Outcomes (1)

  • Symptom-Medication-Score

    during pollen season

Study Arms (2)

2

PLACEBO COMPARATOR
Biological: placebo

1

EXPERIMENTAL
Biological: recombinant birch pollen allergen

Interventions

recombinant birch pollen allergenBIOLOGICAL

subcutaneous injections (s.c.). Dosage escalation phase from 0.75 to 80 microgram maintenance dose s.c. injections of 80 microgram

1
placeboBIOLOGICAL

subcutaneous injections (s.c.). Dosage escalation phase from 0.75 to 80 microgram maintenance dose s.c. injections of 80 microgram

2

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Allergic rhinoconjunctivitis attributable to birch pollen
  • Positive SPT
  • Positive EAST
  • Positive specific provocation test

You may not qualify if:

  • Serious chronic diseases
  • Other perennial allergies

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

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

  • Ludger Klimek, Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2007

First Posted

November 7, 2007

Study Start

September 1, 2007

Primary Completion

June 1, 2010

Study Completion

May 1, 2012

Last Updated

November 8, 2013

Record last verified: 2013-11

Locations

DE(1)