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Trial record 96 of 351 for:    hepatitis b | Open Studies

Follow-up of Chronic Hepatitis B Patients With Comorbid Nonalcoholic Fatty Liver Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Humanity & Healthy GI and Liver Centre
Sponsor:
Information provided by (Responsible Party):
Humanity & Healthy GI and Liver Centre
ClinicalTrials.gov Identifier:
NCT02863757
First received: August 4, 2016
Last updated: August 8, 2016
Last verified: August 2016
  Purpose
The purpose of this study is to determine the disease progression in CHB/NAFLD compared with CHB and NAFLD including liver cirrhosis, cirrhotic complications and hepatocellular carcinoma (HCC).

Condition
Chronic Hepatitis B
Nonalcoholic Fatty Liver Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Disease Progression and Clinical Outcomes in Chronic Hepatitis B (CHB) Patients With Comorbid Nonalcoholic Fatty Liver Disease (NAFLD)

Resource links provided by NLM:


Further study details as provided by Humanity & Healthy GI and Liver Centre:

Primary Outcome Measures:
  • Number of patients with liver cirrhosis, hepatic encephalopathy, esophageal varices, ascites and hepatocellular carcinoma [ Time Frame: Up to 20 years ]

Secondary Outcome Measures:
  • Number of patients with hypertension, obesity, diabetes mellitus, hyperlipidaemia [ Time Frame: Up to 20 years ]
  • Number of patients with liver transplantation and liver-related death [ Time Frame: Up to 20 years ]
  • Diagnosis time of liver cirrhosis, hepatic encephalopathy, esophageal varices, ascites and hepatocellular carcinoma from baseline [ Time Frame: Up to 20 years ]
  • Occurrence time of liver transplantation and liver-related death from baseline [ Time Frame: Up to 20 years ]

Estimated Enrollment: 1500
Study Start Date: August 2016
Estimated Study Completion Date: February 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
CHB Group
Patients with chronic hepatitis B
CHB/NAFLD Group
Patients with chronic hepatitis B and comorbid nonalcoholic fatty liver disease
NAFLD Group
Patients with nonalcoholic fatty liver disease

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Hosptials and primary care clinics
Criteria

Inclusion Criteria:

  • Liver biopsy proved CHB and/or NAFLD at baseline;
  • Chinese
  • Follow-up duration>12 months

Exclusion Criteria:

  • Other liver diseases;
  • Secondary causes of hepatic steatosis;
  • Alcohol abuse;
  • Liver cirrhosis, cirrhosis related complications or HCC at baseline;
  • Malignancy;
  • History of liver transplantation
  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: NCT02863757

Contacts
Contact: George Lau, MD +852 2861 3777 gkklau@netvigator.com

Locations
China, Hong Kong
Humanity and Health GI and Liver Centre Recruiting
Hong Kong, Hong Kong, China, 00852
Contact: George KK Lau, MD    (852)28613777    gkklau@netvigator.com   
Principal Investigator: George KK Lau, MD         
Sponsors and Collaborators
Humanity & Healthy GI and Liver Centre
  More Information

Responsible Party: Humanity & Healthy GI and Liver Centre
ClinicalTrials.gov Identifier: NCT02863757     History of Changes
Other Study ID Numbers: H&H_NAFLD/CHB
Study First Received: August 4, 2016
Last Updated: August 8, 2016
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Viral, Human
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on March 28, 2017