Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prevalence and Screening of Hepatitis C in Belgium in 2015

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02393365
Recruitment Status : Recruiting
First Posted : March 19, 2015
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
Dr Luc Lasser, Brugmann University Hospital

Brief Summary:

Hepatitis C is caused by the hepatitis C virus (HCV) that causes inflammation of the liver that can lead to diminished liver function or liver failure.

The number of chronically infected persons worldwide is estimated to be about 170 million that is 2.35% of the world population. Most people infected with the hepatitis C virus have no symptoms of the disease until the advanced stages of liver disease have occurred, which may take several years. The long-term impact of HCV infection is highly variable, from minimal changes to extensive fibrosis and cirrhosis with or without hepatocellular carcinoma (HCC).

Advanced liver disease (ALD) can lead to significant clinical and economic consequences, including liver transplantation. HCV can reduce life expectancy and impair quality of life. HCV-related complications as well as the highly debilitating effects on patients represent a significant item of expenditure for the National Health Service. Because of the latency of infection, numerous country-specific population analyses suggest that HCV will cause an increasing number of liver-related deaths despite the dramatic drop in incidence and prevalence. These deaths will be related to prevalent HCV infection especially during and after World War II through indiscreet and widespread treatment with intravenous injection using contaminated syringes, needles and remunerated blood donors. Eradicating HCV infection can prevent the complications of HCV-related liver and extrahepatic diseases, including liver necroinflammation, fibrosis, cirrhosis, HCC, and death.

Newly discovered hepatitis C virus (HCV) therapy with direct acting antiviral agents (DAA) like Simeprevir, sofosbuvir open a new chapter in the treatment of chronic hepatitis C. Those new treatment regimens promise oral dosing, higher SVR, shorter duration of treatment and fewer side effects. In a near future all patients should qualify for future all-oral therapies.

However recent analysis have shown that increasing efficacy of treatment alone will not be able to reduce the HCV disease burden. The largest reduction in HCV-related morbidity and mortality can be obtained when higher efficacy therapies is combined with increased diagnosis and treatment rate. With a treatment rate of 10% it is possible to achieve a > 90% decline in total infections by 2030. This would require a 3-5 fold increase in diagnosis and/or treatment for most countries.

The implementation of screening criteria for hepatitis C virus (HCV) such as targeting birth cohorts has potential effect on reducing the progression of hepatitis C virus (HCV) to advanced liver disease (ALD) and could avoid unnecessary high financial costs and preserve quality of life.

Robust data from public health surveillance, surveys of the general and risk populations are required to make decisions in allocating public health resources to diagnose, assess and treat HCV infection.

In Belgium no recent prevalence studies have been conducted. The most cited anti-HCV prevalence is 0.87% based on a study in the Flemish population published in 1997 but collected in 1994. In a French Belgian population there was an overall seroprevalence of 0.6%. However, the population under study was not representative for the whole French community, because the recruited subjects were significantly younger.

A survey among cirrhotic and hepatocellular patients in the French community revealed that 20% of cirrhosis and 47% of hepatocellular cancer were related to hepatitis C. The diagnosis rate of HCV in Belgium is estimated at 43%, signifying that more than 50% of HCV patients remains undiagnosed.

Several studies have already mentioned that aged population especially those born after Second World War are carriers of hepatitis C virus infection. Early detection of HCV infection and treating before progress to advanced liver disease (ALD) is an excellent opportunity to rationalize resource allocation and to improve patients' quality of life.

Recently birth cohort screening recommendations were developed in the United States. In Belgium, no formal screening strategy exists. However the Belgian association of the study of the liver (BASL) recommends targeted HCV screening for high-risk populations (including individuals with a blood transfusion or major medical event prior to 1 july 1990, intranasal or IDU and dialysis patients) in addition to nontargeted screening among pre-operative patients and pregnant women. A birth cohort analysis based on a model suggests a birth cohort between 1950 and 1975 in Belgium. This population should reflect 70% of the viremic population.

In this study, the investigators want to estimate the prevalence of hepatitis C in Belgium in 2014 and to confirm the proposed targeted birth cohort and other risk factors. These data could provide an efficient source of identifying newly diagnosed patients as part of a national screening strategy.


Condition or disease Intervention/treatment Phase
Hepatitis C Other: Questionnaire Procedure: HCV serology Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10000 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Prevalence and Screening of Hepatitis C in Belgium in 2015
Actual Study Start Date : September 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
HCV screening
All patients admitted to the one day clinic for surgery and gastroenterology.
Other: Questionnaire
All patients admitted to the one day clinic for surgery and gastroenterology will be asked, after signing an informed consent, to fill in a questionnaire about HCV risk factors.

Procedure: HCV serology

In case of a pre-operative blood sample an HCV serology will also be done as part of a routine pre-operative screening.

In patients where no pre-operative blood sample is done an additional consent will be asked to perform a blood sample for HCV serology. This qualifies the study as 'interventional' according to the Belgian legislation.





Primary Outcome Measures :
  1. HCV risk factors questionnaire [ Time Frame: up to one day after hospital admission ]
    All patients admitted to the one day clinic for surgery and gastroenterology will be asked, after signing an informed consent, to fill in a questionnaire regarding HCV risk factors (1 page). The collection of the questionnaires and the entering of the data into an electronic database will be done in an anonymous way.

  2. Positive/Negative Hepatitis C serology [ Time Frame: up to 10 days after hospital admission ]
    In case of a pre-operative blood sampling, an HCV detection test will be done on the serum as part of the routine pre-operative screening. The sample will be analyzed in the Hospital Laboratory according to the current belgian guidelines regarding hepatitis C virus detection. In patients where no pre-operative blood sample is done, an additional consent will be asked to take a blood sample for HCV detection. In case of a positive test result (positive HCV serology), patients will be contacted. Those patients will be proposed to contact their family doctor (GP) or a specialist of their choice in order to realize a classic work up and discuss therapeutic options if necessary.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All patients admitted to the one day clinic for surgery and gastroenterology.

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02393365


Contacts
Layout table for location contacts
Contact: Luc Lasser, MD 32 2 4772620 luc.LASSER@chu-brugmann.be

Locations
Layout table for location information
Belgium
St Pierre Hospital Recruiting
Brussels, Belgium, 1000
Contact: Thomas Serste, MD         
CHU Brugmann Recruiting
Brussels, Belgium, 1020
Contact: Luc Lasser, MD    32 2 4772620    luc.LASSER@chu-brugmann.be   
Erasme Recruiting
Brussels, Belgium, 1070
Contact: Christophe Moreno, MD         
UCL St Luc Recruiting
Brussels, Belgium, 1200
Contact: Peter Starkel, MD         
Sponsors and Collaborators
Brugmann University Hospital
Investigators
Layout table for investigator information
Principal Investigator: Luc Lasser, MD CHU Brugmann
Principal Investigator: Christophe Moreno, MD Erasme
Principal Investigator: Thomas Serste, MD CHU St Pierre
Principal Investigator: Peter Starkel, MD UCL - St Luc

Publications:
Wedemeyer H, Duberg AS, Buti M, Rosenberg WM, Frankova S, Esmat G, Örmeci N, Van Vlierberghe H, Gschwantler M, Akarca U, Aleman S, Balık I, Berg T, Bihl F, Bilodeau M, Blasco AJ, Brandão Mello CE, Bruggmann P, Calinas F, Calleja JL, Cheinquer H, Christensen PB, Clausen M, Coelho HS, Cornberg M, Cramp ME, Dore GJ, Doss W, El-Sayed MH, Ergör G, Estes C, Falconer K, Félix J, Ferraz ML, Ferreira PR, García-Samaniego J, Gerstoft J, Giria JA, Gonçales FL Jr, Guimarães Pessôa M, Hézode C, Hindman SJ, Hofer H, Husa P, Idilman R, Kåberg M, Kaita KD, Kautz A, Kaymakoglu S, Krajden M, Krarup H, Laleman W, Lavanchy D, Lázaro P, Marinho RT, Marotta P, Mauss S, Mendes Correa MC, Moreno C, Müllhaupt B, Myers RP, Nemecek V, Øvrehus AL, Parkes J, Peltekian KM, Ramji A, Razavi H, Reis N, Roberts SK, Roudot-Thoraval F, Ryder SD, Sarmento-Castro R, Sarrazin C, Semela D, Sherman M, Shiha GE, Sperl J, Stärkel P, Stauber RE, Thompson AJ, Urbanek P, Van Damme P, van Thiel I, Vandijck D, Vogel W, Waked I, Weis N, Wiegand J, Yosry A, Zekry A, Negro F, Sievert W, Gower E. Strategies to manage hepatitis C virus (HCV) disease burden. J Viral Hepat. 2014 May;21 Suppl 1:60-89. doi: 10.1111/jvh.12249.

Layout table for additonal information
Responsible Party: Dr Luc Lasser, Head of Clinic, Brugmann University Hospital
ClinicalTrials.gov Identifier: NCT02393365     History of Changes
Other Study ID Numbers: CHUB-HCV screening
First Posted: March 19, 2015    Key Record Dates
Last Update Posted: January 23, 2018
Last Verified: January 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr Luc Lasser, Brugmann University Hospital:
Hepatitis C
HCV
screening

Additional relevant MeSH terms:
Layout table for MeSH terms
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections