An Optional Two Year Follow Up Study to Study CP005A | NCT01604018

Studies
An Optional Two Year Follow Up Study to Study CP005A

NCT01604018

Sponsor

Circassia Limited

Status

Completed

Last Update Posted

May 24, 2012Estimated

Enrollment

51Actual

Phase

Not provided

Conditions

Cat Allergy
Rhinoconjunctivitis

Interventions

Not provided

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2012

Primary Completion Date

Apr 2012Actual

Completion Date

Apr 2012Actual

First Submitted Date

May 21, 2012

First Submission Date that Met QC Criteria

May 22, 2012

First Posted Date

May 23, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 23, 2012

Last Update Posted Date

May 24, 2012Estimated

Name	Class
Adiga Life Sciences, Inc.	INDUSTRY
Cetero Research, Toronto	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Cat allergy is an increasingly prevalent condition affecting 10-15% of patients with allergic rhinoconjunctivitis and/or asthma.

The purpose of this optional observational follow-on study is to further evaluate rhinoconjunctivitis symptoms on exposure to cat dander in the EEC among subjects who completed all dosing visits in study CP005 and all visits in study CP005A approximately two years after the start of treatment.

Detailed Description

Subjects who completed all visits in studies CP005 and CP005A will be invited to attend the Screening Visit for CP005B. Subjects will attend for 4 visits to the EEC on successive days. Following the last EEC visit is a follow-up visit which will be performed 3-10 days later.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

51Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo		Subjects previously randomized to receive placebo in study CP005 and completed CP005A.
Cat-PAD Group 1		Subjects previously randomized to receive Cat-PAD dose 1 in study CP005 and completed CP005A.
Cat-Pad Group 2		Subjects previously randomized to receive Cat-PAD dose 2 in study CP005 and completed CP005A.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Total Rhinoconjunctivitis Symptom Score		102-106 weeks after the start of treatment in CP005

Secondary Outcomes

Measure	Description	Time Frame
Total Symptom scores for ocular and nasal symptoms		102-106 weeks after the start of treatment in CP005

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

- Previously randomised into study CP005 and completed all visits in the follow-on study CP005A

Exclusion Criteria:

"Partly controlled" and "uncontrolled" asthma
History of anaphylaxis to cat allergen
Subjects with an FEV1 < 70% of predicted
Subjects who cannot tolerate baseline challenge in the EEC
Treatment with beta-blockers, alpha-adrenoceptor blockers, tranquilizers, or psychoactive drugs
Symptoms of a clinically relevant illness, in the Investigator's opinion, within 6 weeks prior to Screening Visit

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Subjects previously randomised in study CP005 and completed all dosing and PTC in CP005 and all visits in CP005A.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Peter Couroux, MD	Cetero Research, San Antonio	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cetero Research		Mississauga	Ontario		Canada