Hepatitis BNCT02148562
Assessment of Hepatitis B Virus Intra-host Population and Host-specific Immune Marker Diversity
An observational study of Hepatitis B and Hepatitis B, Chronic, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
In this project proposal, the investigators will investigate the genetic alterations of Hepatitis B Virus (HBV) strains circulating in Belgian patients who developed end stage liver disease. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatitis B, Hepatitis B, Chronic, End Stage Liver Disease
- How many people
- 274 participants
- Where
- 1 siteBelgium
- Study dates
- Apr 2014to Dec 2017
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with liver disease related to Hepatitis B in a pre-advanced (chronic infection) and advanced stage (end-stage liver diseases) treated at the Hepatology Department of University Hospital of Leuven
Who may be able to join
- Study group:
- Clinical diagnosis of advanced liver disease related to chronic Hepatitis B infection (cirrhosis, hepatocellular carcinoma,..)
- Availability of serum samples
- Control group:
- Clinical diagnosis of liver disease related to chronic Hepatitis B infection in a pre-advanced stage
- Matched demographic and geographic characteristics to study group
- Availability of serum samples
Who cannot join
- Liver disease caused by other hepato-tropic viruses
- Patients with auto-immune diseases
Trial locations and contacts
1 site in 1 country.
Belgium1 site
University Hospitals Leuven campus Gasthuisberg
Leuven, Flemish Brabant, 3000
About this study
Official title: Assessment of Hepatitis B Virus Intra-host Population and Host-specific Immune Marker Diversity With Next-generation Sequencing: From Chronic Infection to End-stage Liver Disease and Liver Cancer
In this project proposal, the investigators will investigate the genetic alterations of Hepatitis B Virus (HBV) strains circulating in Belgian patients who developed end stage liver disease. Additionally, the investigators will compare and link these data sets with three genetic factors involved in immune system response.
Read the detailed description
This project proposes to identify and characterize the genetic alterations associated with intra-host evolution of HBV from a chronically infection status to an end-stage liver disease status.
- Medical subject headings
- Hepatitis B, Hepatitis B, Chronic, End Stage Liver Disease, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Hepatitis B | Diagnosis of Hepatitis B related liver disease in a pre-advanced stage | |
| End stage liver disease | Diagnosis of advanced liver disease related to Hepatitis B |
What is being measured
The primary outcome is the main question the study is designed to answer.
genetic variants of Hepatitis B
Virus variants will be identified by amino acid or nucleotide variations (insertions or deletions) in different Open Readind Frames (ORFs) of the HBV genome by using next-generation sequencing.
Comparison of virus variants within one patient Comparison of virus variants between patients with end stage liver disease and patients with a chronic Hepatitis B infection.
Determination of the viral load by quantitative Polymerase Chain Reaction (PCR).
Measured: 6 months
Secondary outcomes (1)
genetic variation in host-specific immune markers
Amplification of HLA-A, HLA-B, HLA-C class I and HLA class II using PCR methods and next-generation sequencing
Amplification of KIR genes: 2DS1, 2DS2, 2DS3, 2DS4, 2DS5, 3DS1 and 1D, 2DL1 2DL2, 2DL3, 2DL5 and 3DL1 using PCR methods and next-generation sequencing
Amplification of SNPs in TNF alfa, TGF beta1 and IFN-R using PCR methods and next-generation sequencing
Measured: at day of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2014 (estimated)
- Study startApr 2014
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Time perspective
- Prospective
- Enrolment
- 274 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Fund for Scientific Research, Flanders, Belgium
- Responsible party
- Principal investigator, MahmoudReza Pourkarim, Universitaire Ziekenhuizen KU Leuven
- Investigators
- MahmoudReza Pourkarim, PhD, Principal investigator, UZ Leuven campus Gasthuisberg, Herestraat 49. 3000 Leuven, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02148562
- Sponsor's protocol ID
- S56121
- Other IDs
- 12G1714N
- Status last verified
- May 2014
- First submitted
- 4 Apr 2014
- Last updated
- 28 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Hepatitis B Virus Intra-host Population and Host-specific Immune Marker Diversity With Next-generation Sequencing: From Chronic Infection to End-stage Liver Disease and Liver Cancer
- ClinicalTrials.gov ID
- NCT02148562
- Acronym / sponsor ID
- S56121
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 274 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- Fund for Scientific Research, Flanders, Belgium
- Study start
- Apr 2014
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 28 May 2014 (estimated)
- 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.
In this project proposal, the investigators will investigate the genetic alterations of Hepatitis B Virus (HBV) strains circulating in Belgian patients who developed end stage liver disease. Additionally, the investigators will compare and link these data sets with three genetic factors involved in immune system response.
Detailed description
This project proposes to identify and characterize the genetic alterations associated with intra-host evolution of HBV from a chronically infection status to an end-stage liver disease status.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic Hepatitis B | – | –Diagnosis of Hepatitis B related liver disease in a pre-advanced stage |
| End stage liver disease | – | –Diagnosis of advanced liver disease related to Hepatitis B |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with liver disease related to Hepatitis B in a pre-advanced (chronic infection) and advanced stage (end-stage liver diseases) treated at the Hepatology Department of University Hospital of Leuven
Key inclusion criteria (7 listed)
- Clinical diagnosis of advanced liver disease related to chronic Hepatitis B infection (cirrhosis, hepatocellular carcinoma,..)
- Availability of serum samples
- Clinical diagnosis of liver disease related to chronic Hepatitis B infection in a pre-advanced stage
- Matched demographic and geographic characteristics to study group
- Availability of serum samples
Key exclusion criteria (2 listed)
- Liver disease caused by other hepato-tropic viruses
- Patients with auto-immune diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
genetic variants of Hepatitis B
Time frame: 6 months
Virus variants will be identified by amino acid or nucleotide variations (insertions or deletions) in different Open Readind Frames (ORFs) of the HBV genome by using next-generation sequencing. Comparison of virus variants within one patient Comparison of virus variants between patients with end stage liver disease and patients with a chronic Hepatitis B infection. Determination of the viral load by quantitative Polymerase Chain Reaction (PCR).
1 secondary outcome
genetic variation in host-specific immune markers
Time frame: at day of enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2014.
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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.
MahmoudReza Pourkarim, PhD principal investigator
UZ Leuven campus Gasthuisberg, Herestraat 49. 3000 Leuven, Belgium
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 Hepatitis B and Hepatitis B, Chronic, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 7 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: status not confirmed, as of the sponsor's last update on 28 May 2014. 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 Belgium. 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?
Results are not available in the source record.
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?
genetic variants of Hepatitis B (time frame: 6 months). 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 28 May 2014.