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Trial record 91 of 311 for:    hepatitis b | Recruiting, Not yet recruiting, Available Studies

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

This study is currently recruiting participants.
Verified May 2017 by Humanity and Health Research Centre
Sponsor:
ClinicalTrials.gov Identifier:
NCT02863757
First Posted: August 11, 2016
Last Update Posted: May 9, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Humanity and Health Research Centre
  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 and Health Research 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: December 2026
Estimated Primary Completion Date: December 2026 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 and Health Research Centre
  More Information

Responsible Party: Humanity and Health Research Centre
ClinicalTrials.gov Identifier: NCT02863757     History of Changes
Other Study ID Numbers: H&H_NAFLD/CHB
First Submitted: August 4, 2016
First Posted: August 11, 2016
Last Update Posted: May 9, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
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