Long-term Efficacy and Safety Study With Oralgen Grass Pollen

• Status: Completed
• Trial end date: 2009-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to give additional information on the efficacy, safety and local effects (tolerability) of a dose of sublingual immunotherapy administered once a day, during a second grass pollen season.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Artu Biologicals

Criteria

Inclusion Criteria:

• Patients who meet the in and exclusion criteria for study AB0602 and successfully finished this study.

• Patients who have given their written consent to participate in this study.

• Patients who are willing to comply with the protocol and understand the information given.

• Female patients of childbearing potential are eligible if they are not sexually active or if they use a medically accepted contraceptive method.

• Negative urine pregnancy test if female at the end of the previous study.

Exclusion Criteria:

• Pregnancy, breast-feeding / lactation or sexually active women of childbearing potential who are not using a medically accepted contraceptive method.

• Patients who were non-compliant during study AB0602.

• Patients with a past or current disease, which as judged by the investigator, may affect the patient's participation in or the outcome of this study.