Hepatitis BNCT02687061
Chronic Hepatitis B and C Recall Northern Holland
An observational study of Hepatitis B and Hepatitis C, run by Stichting MDL Holland-Noord.
Trial summary
The project aims to retrieve patients diagnosed with chronic hepatitis B (cHB) and hepatitis C (cHC) who are lost to follow-up.Data files of the Public Health System and microbiology laboratories will be explored for registered cases of cHB and cHC. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatitis B, Hepatitis C
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to Dec 2016
- How long will I take part?
- 1 Year
- 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: The groups will be selected from registries of the Public Health Service (PHS) and medical microbiology laboratories. All positive anti-HCV and HBsAg will be checked and if patients with positive HBsAg or HCV are not known in specialised/hospital care, they will be included in our database.
Who may be able to join
- Diagnosis of chronic hepatitis B (two positive HBsAg measurements with an interval of 6 months)
- Diagnosis of chronic hepatitis C (two positive anti-HCV with an interval of 6 months)
Who cannot join
- Already known in specialized care for chronic HBV or chronic HCV
- Cured from chronic HBV or chronic HCV
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Retrieval of Patients Chronically Infected With Hepatitis B or Hepatitis C in Northern Holland
The project aims to retrieve patients diagnosed with chronic hepatitis B (cHB) and hepatitis C (cHC) who are lost to follow-up.Data files of the Public Health System and microbiology laboratories will be explored for registered cases of cHB and cHC. Subsequently the investigators will compare the registered cases with the list of known cHB and cHC patients in hospital care. Patients lost to follow up will be informed and approached via either the Public Health Service (PHS) or their primary care physician. Identified patients will be invited for re-evaluation at the regional hepatitis centre (The North Western Hospital, formerly Medical Centre Alkmaar) to assess the current status of their chronic disease. Evaluation will be performed in accordance with (inter-)national guidelines, no extra interventions will be performed.
After completion of re-evaluation, a final report will be made and send to both patient and primary care physician with recommendations for further follow-up.
- Conditions
- Hepatitis B, Hepatitis C
- Keywords
- Recall study, Lost to follow-up
- Medical subject headings
- Hepatitis B, Hepatitis C
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 | Patients diagnosed with chronic hepatitis B | |
| Chronic hepatitis C | Patients diagnosed with chronic hepatitis C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver-related morbidity
At baseline, development of liver related morbidity due to chronic viral hepatitis will be assessed.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2016 (estimated)
- Study startFeb 2016
- Primary completionSep 2016 (estimated)
- Study completionDec 2016 (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.
- 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
- Enrolment
- 300 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Stichting MDL Holland-Noord
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- Michael Klemt-Kropp, MD, PhD, Principal investigator, Stichting MDL Holland-Noord
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02687061
- Sponsor's protocol ID
- NL-174-2008
- Status last verified
- Feb 2016
- First submitted
- 8 Feb 2016
- Last updated
- 22 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrieval of Patients Chronically Infected With Hepatitis B or Hepatitis C in Northern Holland
- ClinicalTrials.gov ID
- NCT02687061
- Acronym / sponsor ID
- NL-174-2008
- Conditions
- Hepatitis B, Hepatitis C
- Keywords
- Recall study, Lost to follow-up
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Stichting MDL Holland-NoordUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- Feb 2016
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 22 Feb 2016 (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 project aims to retrieve patients diagnosed with chronic hepatitis B (cHB) and hepatitis C (cHC) who are lost to follow-up.Data files of the Public Health System and microbiology laboratories will be explored for registered cases of cHB and cHC. Subsequently the investigators will compare the registered cases with the list of known cHB and cHC patients in hospital care. Patients lost to follow up will be informed and approached via either the Public Health Service (PHS) or their primary care physician. Identified patients will be invited for re-evaluation at the regional hepatitis centre (The North Western Hospital, formerly Medical Centre Alkmaar) to assess the current status of their chronic disease. Evaluation will be performed in accordance with (inter-)national guidelines, no extra interventions will be performed.
After completion of re-evaluation, a final report will be made and send to both patient and primary care physician with recommendations for further follow-up.
Study design
- Observational model
- Cohort
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic hepatitis B | – | –Patients diagnosed with chronic hepatitis B |
| Chronic hepatitis C | – | –Patients diagnosed with chronic hepatitis C |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The groups will be selected from registries of the Public Health Service (PHS) and medical microbiology laboratories. All positive anti-HCV and HBsAg will be checked and if patients with positive HBsAg or HCV are not known in specialised/hospital care, they will be included in our database.
Key inclusion criteria (2 listed)
- Diagnosis of chronic hepatitis B (two positive HBsAg measurements with an interval of 6 months)
- Diagnosis of chronic hepatitis C (two positive anti-HCV with an interval of 6 months)
Key exclusion criteria (2 listed)
- Already known in specialized care for chronic HBV or chronic HCV
- Cured from chronic HBV or chronic HCV
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
Liver-related morbidity
Time frame: Baseline
At baseline, development of liver related morbidity due to chronic viral hepatitis will be assessed.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2016.
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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.
Michael Klemt-Kropp, MD, PhD principal investigator
Stichting MDL Holland-Noord
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis B and Hepatitis C, run by Stichting MDL Holland-Noord.
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 2 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 22 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Nina Beekmans, MD (+31725484444 ext. 5685, n.beekmans@nwz.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liver-related morbidity (time frame: Baseline). 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 22 Feb 2016.