Evaluation of Safety and Efficacy of Specific Immunotherapy With Recombinant Major Allergens of Timothy Grass Pollen Adsorbed Onto Aluminium-Hydroxide in Patients With IgE-Mediated Allergic Rhinoconjunctivitis +/- Controlled Asthma - Full Text View

Evaluation of Safety and Efficacy of Specific Immunotherapy With Recombinant Major Allergens of Timothy Grass Pollen Adsorbed Onto Aluminium-Hydroxide in Patients With IgE-Mediated Allergic Rhinoconjunctivitis +/- Controlled Asthma (AMETHYST)

This study is currently recruiting participants.
Verified by Allergopharma Joachim Ganzer KG, May 2008

Sponsored by:	Allergopharma Joachim Ganzer KG
Information provided by:	Allergopharma Joachim Ganzer KG
ClinicalTrials.gov Identifier:	NCT00671268

Purpose

Efficacy and Safety from a high-dosed subcutaneous recombinant preparation

Condition	Intervention	Phase
Rhinoconjunctivitis	Biological: AL0704rP Biological: Placebo	Phase III

MedlinePlus related topics:

Asthma

ChemIDplus related topics:

Aluminum hydroxide Algeldrate Aluminum

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Official Title:	Multicentre, Multinational Randomised DBPC Clinical Trial for Evaluation of Safety and Efficacy of Specific Immunotherapy With Recombinant Major Allergens of Timothy Grass Pollen Adsorbed Onto Aluminium-Hydroxide in Patients With IgE-Mediated Allergic Rhinoconjunctivitis +/- Controlled Asthma

Further study details as provided by Allergopharma Joachim Ganzer KG:

Primary Outcome Measures:

Change of Symptom and Medication score [ Designated as safety issue: Yes ]

Estimated Enrollment:	498
Study Start Date:	March 2008
Estimated Study Completion Date:	October 2013
Estimated Primary Completion Date:	October 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental strict subcutaneous	Biological: AL0704rP strict subcutaneous
2: Placebo Comparator strict subcutaneous	Biological: Placebo strict subcutaneous

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Allergic rhinoconjunctivitis attributable to grass pollen
Positive SPT
Positive EAST
Positive provocation test

Exclusion Criteria:

serious disease
other perennial allergies

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00671268

Contacts


Contact: Viola Sprung, Dipl. Dok.	49-40-727-650 ext 308	Viola.Sprung@allergopharma.de

Locations


Germany
	Allergopharma Joachim Ganzer KG	Recruiting
	Reinbek, Germany
	Contact: Jens Kettner, Dr. 49-40-727-650 ext 258 jens.kettner@allergopharma.de

Sponsors and Collaborators

Allergopharma Joachim Ganzer KG

Investigators


Principal Investigator:	Margitta Worm, Professor	unaffiliated

More Information

Leader in specific allergy research and therapy This link exits the ClinicalTrials.gov site

Responsible Party:	Charite, Berlin, unaffiliated ( Professor M.Worm, Principal investigator )
Study ID Numbers:	AL0704rP
First Received:	April 23, 2008
Last Updated:	May 6, 2008
ClinicalTrials.gov Identifier:	NCT00671268
Health Authority:	Germany: Paul-Ehrlich-Institut