CClinicalTrials.gg
Status unknownNCT02687061Updated Feb 22, 2016

Chronic Hepatitis B and C Recall Northern Holland

An observational study in Hepatitis B and Hepatitis C, sponsored by Stichting MDL Holland-Noord. Status unknown. Per ClinicalTrials.gov, last updated 2016-02-22.

Sponsored by Stichting MDL Holland-Noord · Observational

The sponsor has not verified this record recently (last verified Feb 2016), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Enrollment
300
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Hepatitis B
  • Hepatitis C

Keywords

  • Recall study
  • Lost to follow-up
03

In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's planned enrollment of 300 is above the median of 250 across 687 observational studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

This is the only study on the registry with Stichting MDL Holland-Noord as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion Criteria:

  • Already known in specialized care for chronic HBV or chronic HCV
  • Cured from chronic HBV or chronic HCV
05

Study design

Observational model
Cohort
Enrollment
300 participants (estimated)
Target follow-up
1 Year
Patient registry
Yes

Groups and cohorts

  • Chronic hepatitis B

    Patients diagnosed with chronic hepatitis B

  • Chronic hepatitis C

    Patients diagnosed with chronic hepatitis C

06

What researchers measure

Primary outcomes

  1. Liver-related morbidity

    At baseline, development of liver related morbidity due to chronic viral hepatitis will be assessed.

    Time frame: Baseline

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 22, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02687061
Lead sponsor
Stichting MDL Holland-Noord
Collaborators
Gilead Sciences
Responsible party
Sponsor
First posted
Feb 22, 2016
Start date
Feb 2016
Primary completion
Sep 2016 (estimated)
Completion
Dec 2016 (estimated)
Last update
Feb 22, 2016

Study contacts

Nina Beekmans, MD
Contact
n.beekmans@nwz.nl
+31725484444 ext. 5685
Michael Klemt-Kropp, MD, PhD
Contact
M.Klemt-Kropp@nwz.nl
+3172548444 ext. 5058
Michael Klemt-Kropp, MD, PhD
principal investigator · Stichting MDL Holland-Noord

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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