Chronic Hepatitis B and C Recall Northern Holland

Hepatitis C Clinical Trial

Official title:

Retrieval of Patients Chronically Infected With Hepatitis B or Hepatitis C in Northern Holland

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02687061
• Other study ID #: NL-174-2008
• Status: Not yet recruiting
• Phase: N/A
• First received: February 8, 2016
• Last updated: February 17, 2016
• Start date: February 2016
• Est. completion date: December 2016

Study information

• Verified date: February 2016
• Source: Stichting MDL Holland-Noord
• Contact: Nina Beekmans, MD
• Phone: +31725484444
• Email: n.beekmans[@]nwz.nl
• Is FDA regulated: No
• Health authority: Netherlands: Independent Ethics Committee
• Study type: Observational [Patient Registry]

Clinical 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. 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 300
• Est. completion date: December 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis C

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Stichting MDL Holland-Noord	Gilead Sciences

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liver-related morbidity	At baseline, development of liver related morbidity due to chronic viral hepatitis will be assessed.	Baseline	No