Liver FibrosisPVTENCT01241227
Prognosis Value of Transient Elastography and Non-invasive Markers of Fibrosis in Patients With Chronic Liver Disease
An observational study of Liver Fibrosis, run by Association HGE CHU Bordeaux Sud at 1 site in France.
Trial summary
The aim of this prospective study was to compare the 5-year prognostic value of transient elastography (TE), FibroTest (FT), APRI , FIB-4, Lok, and Child-Pugh scores for predicting survival and complications of cirrhosis in patients with chronic liver diseases. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Liver Fibrosis
- How many people
- 1,830 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2003to Feb 2009
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: We included all consecutive patients with an age over eighteen and a chronic hepatitis C of any severity. The determination of chronic hepatitis C was made using standard diagnostic criteria: serological detection of hepatitis C antibodies and positive serum HCV-RNA by PCR for more than 6 months. Exclusion criteria were chronic hepatitis B virus infection and all other causes of chronic liver disease. Patients with HIV infection were included.
Who may be able to join
- chronic hepatitis C
- chronic hepatitis B
- alcoholic liver disease
- non alcoholic steatohepatitis
Who cannot join
- ascitis
Trial locations and contacts
1 site in 1 country.
France1 site
Centre d'Investigation de la Fibrose hépatique Service Hepato-Gastroentérologie Hopital Haut-Leveque
Pessac, 33200
About this study
Official title: Prognosis Value of Transient Elastography and Non-invasive Markers of Fibrosis in Patients With Chronic Liver Disease. A Prospective Follow-up of 4,935 Person-years
The aim of this prospective study was to compare the 5-year prognostic value of transient elastography (TE), FibroTest (FT), APRI , FIB-4, Lok, and Child-Pugh scores for predicting survival and complications of cirrhosis in patients with chronic liver diseases.
Read the detailed description
A total of 1616 patients with chronic hepatitis C was included. At 5 years, 79 patients were dead (39 liver-related deaths) and 16 patients had liver transplantation. Overall survival was 91.7% and survival without liver-related death 94.4%. Survival was significantly decreased in patients diagnosed with severe fibrosis, whatever the non-invasive method used. All these methods were able to predict a shorter survival in this large population. Patients had their prognosis decreased as liver stiffness increased. By multivariate analysis, only FibroTest > 0.74 (OR 4.41, 95%CI 1.62-12.01, p=0.004) was associated with overall survival, and liver stiffness > 9.5 kPa (OR 4.71, 95%CI 1.06-21.01, p=0.04) associated with liver-related death.
- Conditions
- Liver Fibrosis
- Keywords
- liver fibrosis, survival, transient elastography
- Medical subject headings
- Liver Cirrhosis
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 liver disease | All patients with chronic liver disease followed using FibroScan and non-invasive markers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Measured: 3 months
Secondary outcomes (2)
Survival without liver complications
Measured: 3 months
Survival without liver transplantation
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2010 (estimated)
- Study startApr 2003
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Liver FibrosisStudies 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
- 1,830 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association HGE CHU Bordeaux Sud
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, de Ledinghen, Association HGE CHU Bordeaux Sud
- Investigators
- Julien Vergniol, MD, Principal investigator, Association HGE CHU Bordeaux SudJuliette Foucher, MD, Study chair, Association HGE CHU Bordeaux SudEric Terrebonne, MD, Study chair, Association HGE CHU Bordeaux SudWassil Merrouche, Study chair, Association HGE CHU Bordeaux SudVictor De Ledinghen, MD, PhD, Study director, Association HGE CHU Bordeaux SudPierre-Henri Bernard, MD, Study chair, Association HGE CHU Bordeaux SudCouzigou Patrice, MD, PhD, Study chair, Association HGE CHU Bordeaux Sud
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01241227
- Sponsor's protocol ID
- HLV-0403
- Acronym
- PVTE
- Status last verified
- Jul 2023
- First submitted
- 22 Oct 2010
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Vergniol J, Boursier J, Coutzac C, Bertrais S, Foucher J, Angel C, Chermak F, Hubert IF, Merrouche W, Oberti F, de Ledinghen V, Cales P. Evolution of noninvasive tests of liver fibrosis is associated with prognosis in patients with chronic hepatitis C. Hepatology. 2014 Jul;60(1):65-76. doi: 10.1002/hep.27069.
PubMed 24519328Vergniol J, Foucher J, Terrebonne E, Bernard PH, le Bail B, Merrouche W, Couzigou P, de Ledinghen V. Noninvasive tests for fibrosis and liver stiffness predict 5-year outcomes of patients with chronic hepatitis C. Gastroenterology. 2011 Jun;140(7):1970-9, 1979.e1-3. doi: 10.1053/j.gastro.2011.02.058. Epub 2011 Mar 2.
PubMed 21376047
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognosis Value of Transient Elastography and Non-invasive Markers of Fibrosis in Patients With Chronic Liver Disease. A Prospective Follow-up of 4,935 Person-years
- ClinicalTrials.gov ID
- NCT01241227
- Acronym / sponsor ID
- PVTE / HLV-0403
- Conditions
- Liver Fibrosis
- Keywords
- liver fibrosis, survival, transient elastography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,830 participants (actual)
- Lead sponsor
- Association HGE CHU Bordeaux SudUniversity, hospital or other
- Study start
- Apr 2003
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 16 Nov 2010 (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.
The aim of this prospective study was to compare the 5-year prognostic value of transient elastography (TE), FibroTest (FT), APRI , FIB-4, Lok, and Child-Pugh scores for predicting survival and complications of cirrhosis in patients with chronic liver diseases.
Detailed description
A total of 1616 patients with chronic hepatitis C was included. At 5 years, 79 patients were dead (39 liver-related deaths) and 16 patients had liver transplantation. Overall survival was 91.7% and survival without liver-related death 94.4%. Survival was significantly decreased in patients diagnosed with severe fibrosis, whatever the non-invasive method used. All these methods were able to predict a shorter survival in this large population. Patients had their prognosis decreased as liver stiffness increased. By multivariate analysis, only FibroTest > 0.74 (OR 4.41, 95%CI 1.62-12.01, p=0.004) was associated with overall survival, and liver stiffness > 9.5 kPa (OR 4.71, 95%CI 1.06-21.01, p=0.04) associated with liver-related death.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic liver disease | – | –All patients with chronic liver disease followed using FibroScan and non-invasive markers |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We included all consecutive patients with an age over eighteen and a chronic hepatitis C of any severity. The determination of chronic hepatitis C was made using standard diagnostic criteria: serological detection of hepatitis C antibodies and positive serum HCV-RNA by PCR for more than 6 months. Exclusion criteria were chronic hepatitis B virus infection and all other causes of chronic liver disease. Patients with HIV infection were included.
Key inclusion criteria (4 listed)
- chronic hepatitis C
- chronic hepatitis B
- alcoholic liver disease
- non alcoholic steatohepatitis
Key exclusion criteria (1 listed)
- ascitis
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
Overall survival
Time frame: 3 months
2 secondary outcomes
Survival without liver complications
Time frame: 3 months
Survival without liver transplantation
Time frame: 3 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 20 Jul 2023.
- Derived from this study: PubMed 24519328Vergniol J, Boursier J, Coutzac C, Bertrais S, Foucher J, Angel C, Chermak F, Hubert IF, Merrouche W, Oberti F, de Ledinghen V, Cales P. Evolution of noninvasive tests of liver fibrosis is associated with prognosis in patients with chronic hepatitis C. Hepatology. 2014 Jul;60(1):65-76. doi: 10.1002/hep.27069.
- Derived from this study: PubMed 21376047Vergniol J, Foucher J, Terrebonne E, Bernard PH, le Bail B, Merrouche W, Couzigou P, de Ledinghen V. Noninvasive tests for fibrosis and liver stiffness predict 5-year outcomes of patients with chronic hepatitis C. Gastroenterology. 2011 Jun;140(7):1970-9, 1979.e1-3. doi: 10.1053/j.gastro.2011.02.058. Epub 2011 Mar 2.
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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.
Julien Vergniol, MD principal investigator
Association HGE CHU Bordeaux Sud
Juliette Foucher, MD study chair
Association HGE CHU Bordeaux Sud
Eric Terrebonne, MD study chair
Association HGE CHU Bordeaux Sud
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 Liver Fibrosis, run by Association HGE CHU Bordeaux Sud at 1 site in France.
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 4 inclusion and 1 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 20 Jul 2023. 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 France. 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?
Overall survival (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01241227, which also lists 2 linked publications.
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 20 Jul 2023.