Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Trial record 42 of 517 for:    hepatitis b | Open Studies

Chronic Hepatitis B and C Recall Northern Holland

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2016 by Stichting MDL Holland-Noord
Sponsor:
Collaborator:
Gilead Sciences
Information provided by (Responsible Party):
Stichting MDL Holland-Noord
ClinicalTrials.gov Identifier:
NCT02687061
First received: February 8, 2016
Last updated: February 17, 2016
Last verified: February 2016
  Purpose

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.


Condition
Hepatitis B
Hepatitis C

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Target Follow-Up Duration: 1 Year
Official Title: Retrieval of Patients Chronically Infected With Hepatitis B or Hepatitis C in Northern Holland

Resource links provided by NLM:


Further study details as provided by Stichting MDL Holland-Noord:

Primary Outcome Measures:
  • Liver-related morbidity [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    At baseline, development of liver related morbidity due to chronic viral hepatitis will be assessed.


Estimated Enrollment: 300
Study Start Date: February 2016
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Chronic hepatitis B
Patients diagnosed with chronic hepatitis B
Chronic hepatitis C
Patients diagnosed with chronic hepatitis C

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
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.
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02687061

Contacts
Contact: Nina Beekmans, MD +31725484444 ext 5685 n.beekmans@nwz.nl
Contact: Michael Klemt-Kropp, MD, PhD +3172548444 ext 5058 M.Klemt-Kropp@nwz.nl

Sponsors and Collaborators
Stichting MDL Holland-Noord
Gilead Sciences
Investigators
Principal Investigator: Michael Klemt-Kropp, MD, PhD Stichting MDL Holland-Noord
  More Information

Responsible Party: Stichting MDL Holland-Noord
ClinicalTrials.gov Identifier: NCT02687061     History of Changes
Other Study ID Numbers: NL-174-2008 
Study First Received: February 8, 2016
Last Updated: February 17, 2016
Health Authority: Netherlands: Independent Ethics Committee

Keywords provided by Stichting MDL Holland-Noord:
Recall study
Lost to follow-up

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis B
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepadnaviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on September 23, 2016