Clinical Trials Logo
  1. Home
  2. Allergy
  3. NCT00554983
  4. Details
NCT00554983 Clinical Trial

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

Allergy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00554983
Other study ID # AL0702rB
Secondary ID 2007-001029-84
Status Completed
Phase Phase 3
First received November 6, 2007
Last updated November 7, 2013
Start date September 2007
Est. completion date May 2012

Study information
Verified date November 2013
Source Allergopharma GmbH & Co. KG
Contact n/a
Is FDA regulated No
Health authority Germany: Paul-Ehrlich-Institut
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 255
Est. completion date May 2012
Est. primary completion date June 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- Allergic rhinoconjunctivitis attributable to birch pollen

- Positive SPT

- Positive EAST

- Positive specific provocation test

Exclusion Criteria:

- Serious chronic diseases

- Other perennial allergies

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Biological:
• recombinant birch pollen allergen
subcutaneous injections (s.c.). Dosage escalation phase from 0.75 to 80 microgram maintenance dose s.c. injections of 80 microgram
• placebo
subcutaneous injections (s.c.). Dosage escalation phase from 0.75 to 80 microgram maintenance dose s.c. injections of 80 microgram

Locations
Country Name City State
Germany Allergopharma GmbH & Co. KG Reinbek

Sponsors (1)
Lead Sponsor Collaborator
Allergopharma GmbH & Co. KG

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Symptom-Medication-Score during pollen season No
See also
  Status Clinical Trial Phase
Terminated NCT02032056 - Effect of Probiotics in Reducing Infections and Allergies in Young Children During the Complementary Feeding Period N/A
Completed NCT01842711 - Cumulative Irritation Patch Test N/A
Completed NCT01633840 - New Validated Recipes for Double-blind Placebo-controlled Low Dose Food Challenges N/A
Completed NCT00997971 - Growth, Tolerance in Healthy Infants Fed a Partially Hydrolyzed Rice Protein Phase 3
Completed NCT00331929 - Respiratory Health Study of Children in Kiryat Tivon N/A
Completed NCT00220753 - Air Cleaners for Children and Adolescents With Asthma and Dog Allergy N/A
Completed NCT00232518 - Randomised Controlled Clinical Trials of the Effect of Therapeutic Hookworm Infection in Allergic Rhinoconjunctivitis N/A
Completed NCT04126096 - Negative Predictive Value and NIC of Beta-Lactam Antibiotics. N/A
Completed NCT04046731 - Neuromuscular Blocking Agents Utilized During Perioperative Hypersensitivity Evaluation N/A
Completed NCT04004351 - Treatment Modalities in Children and Adolescents Suffering From HDM-induced Allergic Rhinitis and/or Asthma
Not yet recruiting NCT04071821 - Relative Bioavailability Study to Evaluate Cetirizine HCl Gummy 10 mg and Cetirizine HCl Oral Tablets 10 mg Phase 1
Not yet recruiting NCT05997784 - Study of Indoor Air Pollutants and Their Impact in Childhood Health and Wellbeing
Completed NCT04418999 - Safety and Efficacy of Intracanalicular Dexamethasone Compared to Loteprednol Etabonate in Patients With Keratoconus Early Phase 1
Completed NCT04186949 - Early Origins of Allergy and Asthma
Completed NCT02127801 - Single Ascending-dose Study of the Efficacy, Safety, Tolerability, and Pharmacokinetics of REGN1908-1909 in Allergic, Adult Participants Phase 1
Enrolling by invitation NCT05011071 - The Alberta BLOOM Premature Child Study
Not yet recruiting NCT06330974 - Allergy, Asthma, and Atopic Eczema in Finland
Completed NCT02596321 - A Study Investigating the Immunologic Effects and Safety of 60-day Treatment of the ALK HDM Tablets in Adult Subjects With HDM-Induced Allergic Rhinitis and/or Atopic Asthma Phase 3
Completed NCT02306473 - The Leaky Lung Test Early Phase 1
Terminated NCT02601690 - Observational Analysis of T Cell Responses to SPIREs for Multiple Allergens in Subjects With Allergy in North America

External Links