Phase III Cat-PAD Follow-on Study

NCT ID: NCT02040844

Last Updated: 2018-06-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

430 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2017-05-31

Brief Summary

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The purpose of this study is to evaluate the continued effectiveness and safety of Cat-PAD in cat allergic subjects for up to five years after the start of administration of treatment. The study is an optional follow-up study to a phase III double-blind, placebo controlled, Cat-PAD study; no further investigational product is administered.

Detailed Description

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Conditions

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Cat Allergy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Cat-PAD Treatment 1

Received Cat-PAD Treatment 1 in Study CP007 \[NCT01620762\].No further treatment received in CP007A

Group Type OTHER

Received Cat-PAD Treatment 1 in Study CP007 [NCT01620762]

Intervention Type DRUG

Cat-PAD Treatment 2

Received Cat-PAD Treatment 2 in Study CP007 \[NCT01620762\].No further treatment received in CP007A.

Group Type OTHER

Received Cat-PAD Treatment 2 in Study CP007 [NCT01620762]

Intervention Type DRUG

Cat-PAD Treatment 3

Received Cat-PAD Treatment 3 in Study CP007 \[NCT01620762\]. No further treatment received in CP007A.

Group Type OTHER

Received Cat-PAD Treatment 3 in Study CP007 [NCT01620762]

Intervention Type DRUG

Interventions

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Received Cat-PAD Treatment 1 in Study CP007 [NCT01620762]

Intervention Type DRUG

Received Cat-PAD Treatment 2 in Study CP007 [NCT01620762]

Intervention Type DRUG

Received Cat-PAD Treatment 3 in Study CP007 [NCT01620762]

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* previously completed clinical study CP007 \[NCT01620762\]

Exclusion Criteria

* started allergen therapy since completing CP007
* Institutionalised due to a legal or regulatory order
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Circassia Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jörg Kleine-Tebbe, MD

Role: PRINCIPAL_INVESTIGATOR

Clinical Research Center for Dermatology, Allergy & Asthma

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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CP007 A

Identifier Type: -

Identifier Source: org_study_id

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