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SuspendedNCT04222803VIRGADUpdated Apr 9, 2025

VIRal Hepatitis and GAllstone Disease Study

An observational study in Gallstone Attack and Viral Hepatitis, sponsored by Göteborg University. Suspended at 1 site in Sweden. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-04-09.

Sponsored by Göteborg University · Observational

Why this study was suspended
The study is currently on hold owing to the introduction of a new electronic system at some of the participating hospitals.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
350
Ages
18 Years to 100 Years
Sex
All
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Study summary

The study aims to investigate possible associations between ongoing viral hepatitis (i.e. hepatitis A, B, C or E virus infection) and ultrasound or computed tomography-verified gallstone disease.

Read the detailed description

Patients seeking care at emergency room at Sahlgrenska University Hospital, Gothenburg, Sweden undergoing ultrasound or computed tomography for suspected gallstone disease, will be asked if they wish to participate in the study. If they agree, a serum sample will be draw for analysis of anti-HAV IgM, HBsAg, anti-HCV, HCV Core antigen and HEV RNA. The proportion of patients with vs. without ultrasound or computed tomography-verified gallstone disease will be evaluated regarding possible ongoing viral hepatitis (i.e. hepatitis A, B, C or E virus infection).

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Conditions studied

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In context

Hepatitis A

2,710 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's planned enrollment of 350 is above the median of 250 across 687 observational studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

Göteborg University is the lead sponsor of 265 studies on the registry; 46 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with and without ultrasound or computed tomography-verified gallstone disease will be compared for biomarkers of ongoing viral hepatitis (i.e. anti-HAV IgM, HBsAg, HCV Core antigen and HEV RNA).

Inclusion criteria

  • Acute abdominal pain entailing an abdominal ultrasound or computed tomography for suspected gallstone disease at the emergency room at Sahlgrenska University Hospital, Gothenburg
  • Written informed consent
  • Ability to obtain 9 mL serum for analysis of anti-HAV IgM, HBsAg, anti-HCV, HCV Core antigen and HEV RNA

Exclusion criteria

Exclusion Criteria:

  • Not willing to give written informed consent
  • Age below 18 years
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
350 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes
Biospecimen retention
Samples with dna
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What researchers measure

Primary outcomes

  1. Association between ongoing viral hepatitis (i.e. hepatitis A, B, C or E virus infection) and ultrasound or computed tomography-verified gallstone disease

    The proportion of patient with verified gallstone disease having detectable anti-HAV IgM, HBsAg, HCV Core antigen or HEV RNA will be compared with the proportion among patients without verified gallstone disease.

    Time frame: 1 day

  2. Association between ongoing hepatitis A virus infection and ultrasound or computed tomography-verified gallstone disease

    The proportion of patient with verified gallstone disease having detectable anti-HAV IgM will be compared with the proportion among patients without verified gallstone disease.

    Time frame: 1 day

  3. Association between ongoing hepatitis B virus infection and ultrasound or computed tomography-verified gallstone disease

    The proportion of patient with verified gallstone disease having detectable HBsAg will be compared with the proportion among patients without verified gallstone disease.

    Time frame: 1 day

  4. Association between ongoing hepatitis C virus infection and ultrasound or computed tomography-verified gallstone disease

    The proportion of patient with verified gallstone disease having detectable HCV Core antigen will be compared with the proportion among patients without verified gallstone disease.

    Time frame: 1 day

  5. Association between ongoing hepatitis E virus infection and ultrasound or computed tomography-verified gallstone disease

    The proportion of patient with verified gallstone disease having detectable HEV RNA will be compared with the proportion among patients without verified gallstone disease.

    Time frame: 1 day

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Study locations

1 site
  • Södra Älvsborgs Sjukhus
    Borås, 501 82, Sweden
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04222803
Lead sponsor
Göteborg University
Responsible party
Martin Lagging, MD PhD (Principal Investigator, Göteborg University) — Principal investigator
First posted
Jan 10, 2020
Start date
Oct 7, 2022
Primary completion
Oct 9, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Apr 9, 2025

Study contacts

Martin Martin, MD PhD
principal investigator · Göteborg University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is suspended, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.

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