An observational study in Non-Cirrhotic Portal Hypertension and Common Variable Immunodeficiency, sponsored by University Hospital Freiburg. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-01.
Sponsored by University Hospital Freiburg · Observational
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.
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.
54 studies on the registry are indexed under Common Variable Immunodeficiency; 13 are open to participants now.
This study's enrollment of 250 is above the median of 119 across 13 observational studies indexed under Common Variable Immunodeficiency.
Browse Common Variable Immunodeficiency studies →University Hospital Freiburg is the lead sponsor of 94 studies on the registry; 18 are open to participants now.
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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)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with CVID and autoimmune disease, but no liver involvement (normal liver enzymes and normal abdominal ultrasound)
Diagnostic Test: Ultrasound including color doppler ultrasound
Patients with CVID and liver involvement (elevated liver enzymes, abnormal ultrasound and/or abnormal liver biopsy), but no clinically significant portal hypertension
Diagnostic Test: Ultrasound including color doppler ultrasound
Patients with CVID and clinically significant non-cirrhotic portal hypertension (indicated by the presence of ascites or esophageal varices / portal-hypertensive gastropathy).
Diagnostic Test: Ultrasound including color doppler ultrasound
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.
Also known as: Liver stiffness measurement by transient elastography, Spleen stiffness measurement by transient elastography
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.
Time frame: 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.
Time frame: Study inclusion, after 12 months
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
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.
Portal vein flow velocity will be assessed by color doppler ultrasound
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.
ALT is assessed during routine clinical practice
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.
AST is assessed during routine clinical practice
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.
Liver function liver function tests (bilirubin, albumin, INR) are assessed during routine clinical practice
Time frame: 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
Time frame: Study inclusion, after 12 months
Plan to share: Undecided
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This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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