Non-Cirrhotic Portal HypertensionCVID-pHTNCT06145100
Prediction of Portal Hypertension in Patients With CVID (CVID-pHT)
An observational study of Non-Cirrhotic Portal Hypertension and Common Variable Immunodeficiency, run by University Hospital Freiburg at 1 site in Germany.
Trial summary
Patients with CVID will be offered to participate in this observational trial during the routine annual visit in the outpatient clinic at the Center of chronic Immunodeficiency (CCI) of the University Medical Center Freiburg, Germany. Clinical and laboratory data at the time of presentation will be assessed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Cirrhotic Portal Hypertension, Common Variable Immunodeficiency
- What is being tested?
- Ultrasound including color doppler ultrasound
- How many people
- 250 participants
- Where
- 1 siteGermany
- Study dates
- 1 Nov 2023to 30 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with CVID will be included in the study. Patients will be divided into three subgroups: 1) Patients with CVID and autoimmunity, but no liver involvement (n=75) 2) Patients with CVID and liver involvement, defined by elevated liver enzymes, abnormal ultrasound and/or abnormal liver biopsy, but no signs of clinically significant portal hypertension (n=75) 3) Patients with CVID and clinically significant non-cirrhotic portal hypertension (n=75). Further patients with CVID and diagnosed non-cirrhotic portal hypertension between 01/01/2004 and the start of the prospective part of this study (01/01/2023) will be included retrospectively in this study (n=25)
Who may be able to join
- Patients with CVID
Who cannot join
- no written informed consent
- concomitant chronic liver disease (viral hepatitis, alcoholic liver disease, steatitic liver disease, hemochromatosis, primary biliary cholangitis, primary sclerosis cholangitis, M. Wilson, alpha-1-antitrypsin deficiency)
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Medical Center Freiburg, Department of Medicine II
Freiburg im Breisgau, 79106
About this study
Official title: Evaluation of Ultrasound Parameters and Liver and Spleen Stiffness for Prediction of Clinically Significant Portal Hypertension in Patients With Common Variable Immunodeficiency Syndrome
Patients with CVID will be offered to participate in this observational trial during the routine annual visit in the outpatient clinic at the Center of chronic Immunodeficiency (CCI) of the University Medical Center Freiburg, Germany.
Clinical and laboratory data at the time of presentation will be assessed. Additionally, parameters of abdominal ultrasound, duplex sonography of the liver and spleen, and liver and spleen stiffness at the time of presentation will be evaluated. If applicable, clinical and/or interventional parameters indicating clinically significant portal hypertension (i.e. presence of varices or portal-hypertensive gastropathy in esophago-gastroduodenoscopy, presence of ascites) within 12 months prior and after the index visit will be assessed. During the visit, serum/plasma samples and peripheral blood mononuclear cells (PBMC) are collected and stored in an associated biobank.
Read the detailed description
Patients with CVID can be included in the study. The study cohort will consist of three subgroups: 1) Patients with CVID and autoimmunity, but no liver involvement. 2) Patients with CVID and liver involvement, defined by elevated liver enzymes, abnormal ultrasound and/or abnormal liver biopsy, but no signs of clinically significant portal hypertension and 3) Patients with CVID and clinically significant non-cirrhotic portal hypertension. Further, patients with CVID and diagnosed non-cirrhotic portal hypertension between 01/01/2004 and the start of the prospective part of this study (01/01/2023) will be included retrospectively in this study.
Patients will be recruited during the routine annual visit in the outpatient clinic at the Center of chronic Immunodeficiency (CCI) of the University Medical Center Freiburg, Germany. During the visit a standard ultrasound protocol, including size and morphology of liver and spleen, duplex-sonography of the liver, and measurement of liver and spleen stiffness via transient elastography will be performed as a part of the routine clinical diagnostic. Results from endoscopy or other interventions (esophago-gastroduodenoscopy, invasive measurement of hepatic venous-portal pressure gradient, or TIPS implantation, if applicable) within 12 months prior and after the index visit will be assessed. All non-invasive and invasive interventions will be conducted solely based on clinical decisions made independently from the study inclusion as the study is designed as an observational study.
Detailed patient characteristics, epidemiologic, clinical, imaging and laboratory parameters will be assessed and included in an electronic database.
Apart from these data, patients will be asked to participate in biobank sampling including serum/plasma and peripheral blood mononuclear cells (PBMC) samples from the peripheral veins.
All patients recruited in this study will be followed-up for at least 12 months.
Outcome parameters include parameters from abdominal ultrasound, duplex-sonography and stiffness of liver and spleen, presence or development of clinically significant portal hypertension and non-invasive fibrosis scores based on laboratory and ultrasound parameters.
- Being tested
- Ultrasound including color doppler ultrasound
- Keywords
- non-cirrhotic portal hypertension, Common Variable Immunodeficiency, ultrasound, liver stiffness measurement, spleen stiffness measurement
- Medical subject headings
- Common Variable Immunodeficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound including color doppler ultrasoundDiagnostic test
Also called Liver stiffness measurement by transient elastography, Spleen stiffness measurement by transient elastography
Patients with CVID receive color doppler ultrasound of the liver including assessment of portal vein diameter, portal vein flow velocity, hepatic vein diameter and assessment of arterial perfusion. Further liver and spleen stiffness measurement by transient elastography is performed.
| Study group | Role | What they receive |
|---|---|---|
| Patients with CVID and autoimmunity and no liver involvement. | Patients with CVID and autoimmune disease, but no liver involvement (normal liver enzymes and normal abdominal ultrasound) Receives: Diagnostic Test: Ultrasound including color doppler ultrasound | |
| Patients with CVID and liver involvement and no clinical significant portal hypertension | Patients with CVID and liver involvement (elevated liver enzymes, abnormal ultrasound and/or abnormal liver biopsy), but no clinically significant portal hypertension Receives: Diagnostic Test: Ultrasound including color doppler ultrasound | |
| Patients with CVID and clinically significant non-cirrhotic portal hypertension | Patients with CVID and clinically significant non-cirrhotic portal hypertension (indicated by the presence of ascites or esophageal varices / portal-hypertensive gastropathy). Receives: Diagnostic Test: Ultrasound including color doppler ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in liver stiffness between CVID patients with and without liver involvement and with clinically significant portal hypertension.
Liver stiffness will be assessed by transient elastography.
Measured: Study inclusion, after 12 months
Differences in spleen stiffness between CVID patients with and without liver involvement and with clinically significant portal hypertension.
Spleen stiffness will be assessed by transient elastography.
Measured: Study inclusion, after 12 months
Secondary outcomes (6)
Differences in portal vein diameter between CVID patients with and without liver involvement and with clinically significant portal hypertension.
Portal vein diameter will be assessed by color doppler ultrasound
Measured: Study inclusion, after 12 months
Differences in portal vein flow velocity between CVID patients with and without liver involvement and with clinically significant portal hypertension.
Portal vein flow velocity will be assessed by color doppler ultrasound
Measured: Study inclusion, after 12 months
Differences in alanine aminotransfersases (ALT) between CVID patients with and without liver involvement and with clinically significant portal hypertension.
ALT is assessed during routine clinical practice
Measured: Study inclusion, after 12 months
Differences in aspartat aminotransfersases (AST) between CVID patients with and without liver involvement and with clinically significant portal hypertension.
AST is assessed during routine clinical practice
Measured: Study inclusion, after 12 months
Differences in liver function tests (bilirubin, albumin, INR) between CVID patients with and without liver involvement and with clinically significant portal hypertension.
Liver function liver function tests (bilirubin, albumin, INR) are assessed during routine clinical practice
Measured: Study inclusion, after 12 months
Differences in platelets between CVID patients with and without liver involvement and with clinically significant portal hypertension.
Platelets are assessed during routine clinical practice
Measured: Study inclusion, after 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start1 Nov 2023
- Primary completion31 Dec 2025
- Study completion30 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Cirrhotic Portal HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Freiburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Dominik Bettinger, University Hospital Freiburg
- Investigators
- Dominik Bettinger, MD, Principal investigator, University Hospital FreiburgKlaus Warnatz, MD, Principal investigator, University Hospital FreiburgMarlene Reincke, MD, Principal investigator, University Hospital Freiburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06145100
- Sponsor's protocol ID
- CVID-pHT
- Acronym
- CVID-pHT
- Status last verified
- Apr 2026
- First submitted
- 10 Nov 2023
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Ultrasound Parameters and Liver and Spleen Stiffness for Prediction of Clinically Significant Portal Hypertension in Patients With Common Variable Immunodeficiency Syndrome
- ClinicalTrials.gov ID
- NCT06145100
- Acronym / sponsor ID
- CVID-pHT / CVID-pHT
- Keywords
- non-cirrhotic portal hypertension, Common Variable Immunodeficiency, ultrasound, liver stiffness measurement, spleen stiffness measurement
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- University Hospital FreiburgUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 30 Mar 2026 (actual)
- First posted
- 22 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients with CVID will be offered to participate in this observational trial during the routine annual visit in the outpatient clinic at the Center of chronic Immunodeficiency (CCI) of the University Medical Center Freiburg, Germany.
Clinical and laboratory data at the time of presentation will be assessed. Additionally, parameters of abdominal ultrasound, duplex sonography of the liver and spleen, and liver and spleen stiffness at the time of presentation will be evaluated. If applicable, clinical and/or interventional parameters indicating clinically significant portal hypertension (i.e. presence of varices or portal-hypertensive gastropathy in esophago-gastroduodenoscopy, presence of ascites) within 12 months prior and after the index visit will be assessed. During the visit, serum/plasma samples and peripheral blood mononuclear cells (PBMC) are collected and stored in an associated biobank.
Detailed description
Patients with CVID can be included in the study. The study cohort will consist of three subgroups: 1) Patients with CVID and autoimmunity, but no liver involvement. 2) Patients with CVID and liver involvement, defined by elevated liver enzymes, abnormal ultrasound and/or abnormal liver biopsy, but no signs of clinically significant portal hypertension and 3) Patients with CVID and clinically significant non-cirrhotic portal hypertension. Further, patients with CVID and diagnosed non-cirrhotic portal hypertension between 01/01/2004 and the start of the prospective part of this study (01/01/2023) will be included retrospectively in this study.
Patients will be recruited during the routine annual visit in the outpatient clinic at the Center of chronic Immunodeficiency (CCI) of the University Medical Center Freiburg, Germany. During the visit a standard ultrasound protocol, including size and morphology of liver and spleen, duplex-sonography of the liver, and measurement of liver and spleen stiffness via transient elastography will be performed as a part of the routine clinical diagnostic. Results from endoscopy or other interventions (esophago-gastroduodenoscopy, invasive measurement of hepatic venous-portal pressure gradient, or TIPS implantation, if applicable) within 12 months prior and after the index visit will be assessed. All non-invasive and invasive interventions will be conducted solely based on clinical decisions made independently from the study inclusion as the study is designed as an observational study.
Detailed patient characteristics, epidemiologic, clinical, imaging and laboratory parameters will be assessed and included in an electronic database.
Apart from these data, patients will be asked to participate in biobank sampling including serum/plasma and peripheral blood mononuclear cells (PBMC) samples from the peripheral veins.
All patients recruited in this study will be followed-up for at least 12 months.
Outcome parameters include parameters from abdominal ultrasound, duplex-sonography and stiffness of liver and spleen, presence or development of clinically significant portal hypertension and non-invasive fibrosis scores based on laboratory and ultrasound parameters.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with CVID and autoimmunity and no liver involvement. | – | Diagnostic Test: Ultrasound including color doppler ultrasoundPatients with CVID and autoimmune disease, but no liver involvement (normal liver enzymes and normal abdominal ultrasound) |
| Patients with CVID and liver involvement and no clinical significant portal hypertension | – | Diagnostic Test: Ultrasound including color doppler ultrasoundPatients with CVID and liver involvement (elevated liver enzymes, abnormal ultrasound and/or abnormal liver biopsy), but no clinically significant portal hypertension |
| Patients with CVID and clinically significant non-cirrhotic portal hypertension | – | Diagnostic Test: Ultrasound including color doppler ultrasoundPatients with CVID and clinically significant non-cirrhotic portal hypertension (indicated by the presence of ascites or esophageal varices / portal-hypertensive gastropathy). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with CVID will be included in the study. Patients will be divided into three subgroups: 1) Patients with CVID and autoimmunity, but no liver involvement (n=75) 2) Patients with CVID and liver involvement, defined by elevated liver enzymes, abnormal ultrasound and/or abnormal liver biopsy, but no signs of clinically significant portal hypertension (n=75) 3) Patients with CVID and clinically significant non-cirrhotic portal hypertension (n=75). Further patients with CVID and diagnosed non-cirrhotic portal hypertension between 01/01/2004 and the start of the prospective part of this study (01/01/2023) will be included retrospectively in this study (n=25)
Key inclusion criteria (1 listed)
- Patients with CVID
Key exclusion criteria (2 listed)
- no written informed consent
- concomitant chronic liver disease (viral hepatitis, alcoholic liver disease, steatitic liver disease, hemochromatosis, primary biliary cholangitis, primary sclerosis cholangitis, M. Wilson, alpha-1-antitrypsin deficiency)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound including color doppler ultrasoundAlso: Liver stiffness measurement by transient elastography, Spleen stiffness measurement by transient elastographyPatients with CVID receive color doppler ultrasound of the liver including assessment of portal vein diameter, portal vein flow velocity, hepatic vein diameter and assessment of arterial perfusion. Further liver and spleen stiffness measurement by transient elastography is performed. | Diagnostic test | Patients with CVID and autoimmunity and no liver involvement., Patients with CVID and clinically significant non-cirrhotic portal hypertension, Patients with CVID and liver involvement and no clinical significant portal hypertension |
Primary outcome
Differences in liver stiffness between CVID patients with and without liver involvement and with clinically significant portal hypertension.
Time frame: Study inclusion, after 12 months
Liver stiffness will be assessed by transient elastography.
Differences in spleen stiffness between CVID patients with and without liver involvement and with clinically significant portal hypertension.
Time frame: Study inclusion, after 12 months
Spleen stiffness will be assessed by transient elastography.
6 secondary outcomes
Differences in portal vein diameter between CVID patients with and without liver involvement and with clinically significant portal hypertension.
Time frame: Study inclusion, after 12 months
Differences in portal vein flow velocity between CVID patients with and without liver involvement and with clinically significant portal hypertension.
Time frame: Study inclusion, after 12 months
Differences in alanine aminotransfersases (ALT) between CVID patients with and without liver involvement and with clinically significant portal hypertension.
Time frame: Study inclusion, after 12 months
Differences in aspartat aminotransfersases (AST) between CVID patients with and without liver involvement and with clinically significant portal hypertension.
Time frame: Study inclusion, after 12 months
Differences in liver function tests (bilirubin, albumin, INR) between CVID patients with and without liver involvement and with clinically significant portal hypertension.
Time frame: Study inclusion, after 12 months
Differences in platelets between CVID patients with and without liver involvement and with clinically significant portal hypertension.
Time frame: Study inclusion, after 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dominik Bettinger, MD principal investigator
University Hospital Freiburg
Klaus Warnatz, MD principal investigator
University Hospital Freiburg
Marlene Reincke, MD principal investigator
University Hospital Freiburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Cirrhotic Portal Hypertension and Common Variable Immunodeficiency, run by University Hospital Freiburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in liver stiffness between CVID patients with and without liver involvement and with clinically significant portal hypertension. (time frame: Study inclusion, after 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026; AzTrials last refreshed its copy on 8 Nov 2026.