Hepatitis CDeViCHONCT04437277
Screening for Chronic Hepatitis C Virus in Hospitalized Patients
A study testing Hepatitis C, serology in people with Hepatitis C, run by Hospital St. Joseph, Marseille, France at 1 site in France.
Trial summary
Chronic viral hepatitis C is a public health problem and several management recommendations are available. According to the HAS, hepatitis C screening consists of a targeted screening of people at risk of infection by the virus, in particular to drug users, to people from countries with a high prevalence of the virus… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C
- What is being tested?
- Hepatitis C, serology
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,000 participants
- Where
- 1 siteFrance
- Study dates
- 22 Nov 2019to 30 Nov 2021
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all in-patient patients and consenting to participate at the study.
Who cannot join
- Refusal to participate in the study
- Contraindication to a blood sample (Impossibility of a peripheral venous approach and any clinical condition that may indicate a venous sample)
- Minor patient
- Patient unable to express consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Screening for Chronic Hepatitis C Virus in Hospitalized Patients at Saint Joseph Hospital in Marseille
Chronic viral hepatitis C is a public health problem and several management recommendations are available. According to the HAS, hepatitis C screening consists of a targeted screening of people at risk of infection by the virus, in particular to drug users, to people from countries with a high prevalence of the virus or who have received care in those countries, people transfused before 1992, or people who have been or have been imprisoned. Our study proposes to evaluate hepatitis C screening in consenting patients hospitalized in Saint Joseph. These previously identified patients with comorbidities will be cared for according to current national practices that reduce HCV morbidity and mortality.
Read the detailed description
Hepatitis C screening is based on a blood test, in particular the Elisa test, which looks for anti-HCV antibodies. In the case of positive C viral serology, the search for the C virus from a blood test makes it possible to detect the genome (RNA) of the virus, which is thus directly detected by a so-called "PCR" technique. Although screening activity is important in France, it remains insufficient. In December 2016, HAS concluded that risk-based targeted screening has limitations and contributes to the persistence of a hidden epidemic of viral C infection. It is estimated that 75,000 people are unaware of being carriers of the hepatitis C virus. However, there is safe, effective and well-tolerated treatment. With duration of 8 to 12 weeks it allows a healing of HCV in more than 95% of subjects. AFEF recommendations aim to achieve viral elimination C (as early as 2025). This elimination is defined as a 90% decrease in new infections associated with a 65% reduction in HCV mortality. OMS has planned this target for 2030. To achieve this goal, a number of measures are gradually being implemented focusing on universal treatment and universal screening. The hospital may be a place where systematic screening is interesting. In 2017, the prevalence of anti-HCV positive antibodies in the facility, apart from the Hepato-Gastroenterology service, was 1.7%, more than twice the estimated prevalence in our general population. These data give a rationale for the realization of this study.
- Conditions
- Hepatitis C
- Being tested
- Hepatitis C, serology
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hepatitis C, serologyDiagnostic test
Also called Hepatitis C, PCR
Inclusion of patients in conventional hospitalization at Saint Joseph Hospital. Each consenting patient benefits from a screening HCV serology carried out during a biological sample indicated by his state of health. In the case of positive HCV serology, an additional sample will be taken in search of viral replication. All detectable HCV PCR patients will be admitted to hepatology consultation for assessment of liver status including non-invasive methods and possible treatment according to the conditions of the Marketing Authorization and recommendations for routine clinical practice. Data on management (treatment or non-treatment and treatment outcome: prolonged virological response 12 weeks after completion of treatment) will be collected.
| Study group | Role | What they receive |
|---|---|---|
| Patients consenting | Experimental | Not described Receives: Diagnostic Test: Hepatitis C, serology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of hepatitis C through the different department of Saint Joseph Hospital
At every hospitalized patients the trial will be presented. the viral screening will be proposed for the purpose of treating patients who will be viremic
Measured: one day
Secondary outcomes (3)
number of viremic patients with risk factors
Identify viremic patients enrolled with identified risk factors
Measured: one day
number of viremic patients without risk factors
Identify viremic patients enrolled without identified risk factors
Measured: one day
number of patients who refuse viral screening
study will be presented to all hospitalized patients in Saint Joseph Hospital but investigators will estimate pateints who refuse to participate
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start22 Nov 2019
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Monocentric interventional longitudinal risk and minimal constraint study, consenting and consecutive in-patients recruited within the hospital
- Masking
- None (open label)
- Enrolment
- 5,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital St. Joseph, Marseille, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04437277
- Sponsor's protocol ID
- 2018-A02595-50
- Acronym
- DeViCHO
- Status last verified
- Jan 2022
- First submitted
- 6 Jan 2020
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening for Chronic Hepatitis C Virus in Hospitalized Patients at Saint Joseph Hospital in Marseille
- ClinicalTrials.gov ID
- NCT04437277
- Acronym / sponsor ID
- DeViCHO / 2018-A02595-50
- Conditions
- Hepatitis C
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,000 participants (actual)
- Lead sponsor
- Hospital St. Joseph, Marseille, FranceUniversity, hospital or other
- Study start
- 22 Nov 2019 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 18 Jun 2020 (actual)
- 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.
Chronic viral hepatitis C is a public health problem and several management recommendations are available. According to the HAS, hepatitis C screening consists of a targeted screening of people at risk of infection by the virus, in particular to drug users, to people from countries with a high prevalence of the virus or who have received care in those countries, people transfused before 1992, or people who have been or have been imprisoned. Our study proposes to evaluate hepatitis C screening in consenting patients hospitalized in Saint Joseph. These previously identified patients with comorbidities will be cared for according to current national practices that reduce HCV morbidity and mortality.
Detailed description
Hepatitis C screening is based on a blood test, in particular the Elisa test, which looks for anti-HCV antibodies. In the case of positive C viral serology, the search for the C virus from a blood test makes it possible to detect the genome (RNA) of the virus, which is thus directly detected by a so-called "PCR" technique. Although screening activity is important in France, it remains insufficient. In December 2016, HAS concluded that risk-based targeted screening has limitations and contributes to the persistence of a hidden epidemic of viral C infection. It is estimated that 75,000 people are unaware of being carriers of the hepatitis C virus. However, there is safe, effective and well-tolerated treatment. With duration of 8 to 12 weeks it allows a healing of HCV in more than 95% of subjects. AFEF recommendations aim to achieve viral elimination C (as early as 2025). This elimination is defined as a 90% decrease in new infections associated with a 65% reduction in HCV mortality. OMS has planned this target for 2030. To achieve this goal, a number of measures are gradually being implemented focusing on universal treatment and universal screening. The hospital may be a place where systematic screening is interesting. In 2017, the prevalence of anti-HCV positive antibodies in the facility, apart from the Hepato-Gastroenterology service, was 1.7%, more than twice the estimated prevalence in our general population. These data give a rationale for the realization of this study.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Monocentric interventional longitudinal risk and minimal constraint study, consenting and consecutive in-patients recruited within the hospital
| Arm | Type | Receives |
|---|---|---|
| Patients consenting | Experimental | Diagnostic Test: Hepatitis C, serology |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all in-patient patients and consenting to participate at the study.
Key exclusion criteria (4 listed)
- Refusal to participate in the study
- Contraindication to a blood sample (Impossibility of a peripheral venous approach and any clinical condition that may indicate a venous sample)
- Minor patient
- Patient unable to express consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hepatitis C, serologyAlso: Hepatitis C, PCRInclusion of patients in conventional hospitalization at Saint Joseph Hospital. Each consenting patient benefits from a screening HCV serology carried out during a biological sample indicated by his state of health. In the case of positive HCV serology, an additional sample will be taken in search of viral replication. All detectable HCV PCR patients will be admitted to hepatology consultation for assessment of liver status including non-invasive methods and possible treatment according to the conditions of the Marketing Authorization and recommendations for routine clinical practice. Data on management (treatment or non-treatment and treatment outcome: prolonged virological response 12 weeks after completion of treatment) will be collected. | Diagnostic test | Patients consenting |
Primary outcome
Prevalence of hepatitis C through the different department of Saint Joseph Hospital
Time frame: one day
At every hospitalized patients the trial will be presented. the viral screening will be proposed for the purpose of treating patients who will be viremic
3 secondary outcomes
number of viremic patients with risk factors
Time frame: one day
number of viremic patients without risk factors
Time frame: one day
number of patients who refuse viral screening
Time frame: one day
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 11 Jan 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hepatitis C, serology in people with Hepatitis C, run by Hospital St. Joseph, Marseille, France 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 1 inclusion and 4 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 11 Jan 2022. 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?
Prevalence of hepatitis C through the different department of Saint Joseph Hospital (time frame: one day). 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 11 Jan 2022.