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Efficacy and Safety From a Recombinant Folding Variant of Bet v 1

A

Allergopharma

Status and phase

Completed
Phase 3

Conditions

Allergy

Treatments

Biological: recombinant birch pollen allergen
Biological: placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00554983
2007-001029-84 (EudraCT Number)
AL0702rB

Details and patient eligibility

About

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

Enrollment

255 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • Serious chronic diseases
  • Other perennial allergies

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

255 participants in 2 patient groups, including a placebo group

2
Placebo Comparator group
Treatment:
Biological: placebo
1
Experimental group
Treatment:
Biological: recombinant birch pollen allergen

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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