Immunmodulation in Patients With HHT

• Sponsor: University Hospital, Essen (Other)
• Overall Status: Completed
• CT.gov ID: NCT02983253
• Collaborator: (none)
• Enrollment: 124
• Location: 1
• Duration (Months): 40
• Patients Per Site Per Month: 3.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hereditary Haemorrhagic Telangiectasia (HHT)	Other: blood sample

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 Design

• Study Type: Observational
• Actual Enrollment: 124 participants
• Observational Model: Cohort
• Time Perspective: Cross-Sectional
• Official Title: Immunmodulation in Patients With HHT
• Study Start Date: Jun 1, 2016
• Actual Primary Completion Date: Oct 1, 2019
• Actual Study Completion Date: Oct 1, 2019

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Amounts of leucocytes in patients with HHT [November 2016 - December 2018]

Secondary Outcome Measures

1. Differences in distribution of leucocytes in patients with HHT [November 2016 - December 2018]

Other Outcome Measures

1. Functional properties of leucocytes in patients with HHT [November 2016 - December 2018]

2. Differences in size of leucocytes in patients with HHT [November 2016 - December 2018]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• aged 18 or over, HHT

Exclusion Criteria:

• Unable to provide informed consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Essen	Essen		Germany	45147

Sponsors and Collaborators

• University Hospital, Essen

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Urban Geisthoff, Prof. Dr. med. Urban Geisthoff, University Hospital, Essen
• ClinicalTrials.gov Identifier: NCT02983253
• Other Study ID Numbers: ImmunUHEssen
• First Posted: Dec 6, 2016
• Last Update Posted: Dec 20, 2019
• Last Verified: Dec 1, 2019

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Additional relevant MeSH terms: Telangiectasis; Telangiectasia, Hereditary Hemorrhagic

Study Results

No Results Posted as of Dec 20, 2019