Immunmodulation in Patients With HHT

December 18, 2019 updated by: Urban Geisthoff, University Hospital, Essen

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

124

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Essen, Germany, 45147
        • University Hospital Essen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Inclusion Criteria: Aged 18 or over, HHT,

Description

Inclusion Criteria:

  • aged 18 or over, HHT

Exclusion Criteria:

  • Unable to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with HHT
blood sample of patients with HHT
Other: blood sample
none, only laboratory tests on blood serum
probands
blood sample of healthy controls
Other: blood sample
none, only laboratory tests on blood serum

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Essen

Investigators

  • Principal Investigator: Urban Geisthoff, Prof.Dr.med., University Hospital, Essen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Actual)

October 1, 2019

Study Completion (Actual)

October 1, 2019

Study Registration Dates

First Submitted

December 2, 2016

First Submitted That Met QC Criteria

December 2, 2016

First Posted (Estimate)

December 6, 2016

Study Record Updates

Last Update Posted (Actual)

December 20, 2019

Last Update Submitted That Met QC Criteria

December 18, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ImmunUHEssen

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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