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OpenTrials
Completed

NCT Number: NCT00671268

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

Efficacy and Safety from a high-dosed subcutaneous recombinant preparation

Completed

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Key information

Conditions

Rhinoconjunctivitis

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Allergopharma GmbH & Co. KG

Reinbek, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • serious disease
  • other perennial allergies

Treatment and study plan

AL0704rP

Biological

strict subcutaneous

Other names: "na"

Placebo

Biological

strict subcutaneous

Other names: "na"

Primary outcomes

  1. Change of Symptom and Medication score

    Time frame: during the baseline and the following two pollen seasons

Sponsors and collaborators

Lead sponsor

Allergopharma GmbH & Co. KG

Industry

Registry information

Official study 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

Acronym: AMETHYST

Important dates

Study start
2008
Primary completion
2012
Study completion
2013
First posted
May 5, 2008
Registry last updated
Nov 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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