An Optional Follow-up Study to Evaluate the Continued Effectiveness and Safety of Cat-PAD in Cat Allergic Subjects up to Five Years after the Administration of Treatment

Phase 1

• Conditions: Treatment of cat allergen induced rhinoconjunctivitis in patients with clinically relevant symptoms; MedDRA version: 19.0Level: LLTClassification code 10034382Term: Perennial allergic rhinitisSystem Organ Class: 100000004855; Therapeutic area: Diseases [C] - Immune System Diseases [C20]

• Registration Number: EUCTR2013-004669-15-CZ
• Lead Sponsor: Circassia Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04-16
• Last Update Posted: 3 July 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1182

Inclusion Criteria

1. Previously randomised into the clinical study CP007 and completed PAC3.
2. Provide written informed consent or assent, as appropriate. (For subjects less than 18 years a Parent/Guardian will also be required to provide written informed consent).
3. Willing and able to comply with the study requirements.
Are the trial subjects under 18? yes
Number of subjects for this age range: 236
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 946
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Started allergen immunotherapy since completing CP007.
2. Has been informed of the treatment received in study CP007.
3. Dependent on the Investigator/site either for employment or education or are
first degree relatives or partners of the Investigator/study staff.
4. Subjects institutionalised due to a legal or regulatory order

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified