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

Primary Purpose

Allergy

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
recombinant birch pollen allergen
placebo
Sponsored by
Allergopharma GmbH & Co. KG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergy focused on measuring Recombinant birch pollen allergy, IgE-mediated allergic disease attributed to birch pollen

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Allergopharma GmbH & Co. KG

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

2

1

Arm Description

Outcomes

Primary Outcome Measures

Symptom-Medication-Score

Secondary Outcome Measures

Full Information

First Posted
November 6, 2007
Last Updated
November 7, 2013
Sponsor
Allergopharma GmbH & Co. KG
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1. Study Identification

Unique Protocol Identification Number
NCT00554983
Brief Title
Efficacy and Safety From a Recombinant Folding Variant of Bet v 1
Official Title
A Multicentre Randomised Placebo-controlled Double-blind Pivotal Clinical Trial for the Evaluation of Safety and Efficacy of Specific Immunotherapy With an Aluminium Hydroxide-adsorbed Recombinant Hypoallergenic Derivative of the Major Birch Pollen Allergen, rBet v 1-FV
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergopharma GmbH & Co. KG

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergy
Keywords
Recombinant birch pollen allergy, IgE-mediated allergic disease attributed to birch pollen

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
255 (Actual)

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
Placebo Comparator
Arm Title
1
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
recombinant birch pollen allergen
Intervention Description
subcutaneous injections (s.c.). Dosage escalation phase from 0.75 to 80 microgram maintenance dose s.c. injections of 80 microgram
Intervention Type
Biological
Intervention Name(s)
placebo
Intervention Description
subcutaneous injections (s.c.). Dosage escalation phase from 0.75 to 80 microgram maintenance dose s.c. injections of 80 microgram
Primary Outcome Measure Information:
Title
Symptom-Medication-Score
Time Frame
during pollen season

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Allergic rhinoconjunctivitis attributable to birch pollen Positive SPT Positive EAST Positive specific provocation test Exclusion Criteria: Serious chronic diseases Other perennial allergies
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ludger Klimek, Professor
Official's Role
Principal Investigator
Facility Information:
Facility Name
Allergopharma GmbH & Co. KG
City
Reinbek
ZIP/Postal Code
21465
Country
Germany

12. IPD Sharing Statement

Links:
URL
http://www.allergopharma.de
Description
Leader in specific allergy research and therapy
URL
https://www.clinicaltrialsregister.eu/ctr-search/trial/2007-001029-84/DE
Description
Click here for information about this trial in the European Clinical Trials Register

Learn more about this trial

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

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