Chronic Hepatitis B and C Recall Northern Holland

NCT02687061 | Unknown

• 1 other identifier: NL-174-2008
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hepatitis B; Hepatitis C

Keywords

Recall study; Lost to follow-up

Outcome Measures

Primary Outcomes (1)

• Liver-related morbidity

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

  Baseline

Study Arms (2)

Chronic hepatitis B

Patients diagnosed with chronic hepatitis B

Chronic hepatitis C

Patients diagnosed with chronic hepatitis C

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Stichting MDL Holland-Noord: lead
• Gilead Sciences: collaborator

MeSH Terms

Conditions

Hepatitis B; Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases; Flaviviridae Infections; RNA Virus Infections

Study Officials

• Michael Klemt-Kropp, MD, PhD

  Stichting MDL Holland-Noord

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nina Beekmans, MD

CONTACT

+31725484444; n.beekmans@nwz.nl

Michael Klemt-Kropp, MD, PhD

CONTACT

+3172548444; M.Klemt-Kropp@nwz.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2016
• First Posted: February 22, 2016
• Study Start: February 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: December 1, 2016
• Last Updated: February 22, 2016

Record last verified: 2016-02