Immunmodulation in Patients With HHT | NCT02983253

Studies
Immunmodulation in Patients With HHT

NCT02983253

Sponsor

University Hospital, Essen

Status

Completed

Last Update Posted

Dec 20, 2019Actual

Enrollment

124Actual

Phase

Not provided

Conditions

Hereditary Haemorrhagic Telangiectasia (HHT)

Interventions

blood sample

Countries

Germany

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

Dec 2019

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

Jun 2016

Primary Completion Date

Oct 2019Actual

Completion Date

Oct 2019Actual

First Submitted Date

Dec 2, 2016

First Submission Date that Met QC Criteria

Dec 2, 2016

First Posted Date

Dec 6, 2016Estimated

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

Dec 18, 2019

Last Update Posted Date

Dec 20, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Urban Geisthoff, Prof. Dr. med. Urban Geisthoff, University Hospital, EssenPrincipal Investigator

Lead Sponsor

University Hospital, EssenOTHER

Collaborators

Not provided

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

Hereditary haemorrhagic telangiectasia (HHT), also known as Rendu-Osler-Weber syndrome, is an inherited multisystemic disorder. Literature suggests that HHT is often associated with higher frequency of infectious diseases.

The purpose of this study is to evaluate a variety of immunologic parameters in the blood serum of HHT patients in comparison to probands.

Detailed Description

Hereditary haemorrhagic telangiectasia (HHT), also known as Rendu-Osler-Weber syndrome, is an inherited multisystemic disorder with recurrent epistaxis, mucocutaneous telangiectasia and visceral arteriovenous malformations. Literature and the investigators' observation suggest that HHT is often associated with higher frequency of infectious diseases. This might be a hint for a immunocompromised situation.

The purpose of this study is to evaluate a variety of immunologic parameters in the blood serum of HHT patients in comparison to probands.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

124Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with HHT		blood sample of patients with HHT	Other: blood sample
probands		blood sample of healthy controls	Other: blood sample

Interventions

Name	Type	Description	Arm Group Labels	Other Names
blood sample	Other	none, only laboratory tests on blood serum	Patients with HHT probands

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Amounts of leucocytes in patients with HHT		November 2016 - December 2018

Secondary Outcomes

Measure	Description	Time Frame
Differences in distribution of leucocytes in patients with HHT		November 2016 - December 2018

Other Outcomes

Measure	Description	Time Frame
Functional properties of leucocytes in patients with HHT		November 2016 - December 2018
Differences in size of leucocytes in patients with HHT		November 2016 - December 2018

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

aged 18 or over, HHT

Exclusion Criteria:

Unable to provide informed consent

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Inclusion Criteria: Aged 18 or over, HHT,

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Urban Geisthoff, Prof.Dr.med.	University Hospital, Essen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Essen		Essen		45147	Germany

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013683	Telangiectasia, Hereditary Hemorrhagic

Ancestor Terms

ID	Term
D020141	Hemostatic Disorders
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D013684	Telangiectasis

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided