Chronic Hepatitis B and C Recall Northern Holland

NCT ID: NCT02687061

Last Updated: 2016-02-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-29

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatitis B Hepatitis C

Study Design

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Observational Model Type

COHORT

Study Groups

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Chronic hepatitis B

Patients diagnosed with chronic hepatitis B

No interventions assigned to this group

Chronic hepatitis C

Patients diagnosed with chronic hepatitis C

No interventions assigned to this group

Eligibility Criteria

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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

* Already known in specialized care for chronic HBV or chronic HCV
* Cured from chronic HBV or chronic HCV
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gilead Sciences

INDUSTRY

Sponsor Role collaborator

Stichting MDL Holland-Noord

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Klemt-Kropp, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Stichting MDL Holland-Noord

Central Contacts

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Nina Beekmans, MD

Role: CONTACT

+31725484444 ext. 5685

Michael Klemt-Kropp, MD, PhD

Role: CONTACT

+3172548444 ext. 5058

Other Identifiers

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NL-174-2008

Identifier Type: -

Identifier Source: org_study_id

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