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Trial record 111 of 518 for:    hepatitis b | Open Studies

A Hepatitis B With Hepatic Steatosis Study (HBHS)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2015 by Fatty Liver and Alcoholic Liver Disease Study Group, China
Sponsor:
Collaborator:
Unimed Scientific Inc.
Information provided by (Responsible Party):
Fatty Liver and Alcoholic Liver Disease Study Group, China
ClinicalTrials.gov Identifier:
NCT02392598
First received: March 13, 2015
Last updated: August 3, 2015
Last verified: August 2015
  Purpose
This is an epidemiologic study on effect of hepatic steatosis on prognosis and outcomes of patients with chronic hepatitis B.

Condition
Hepatitis B, Chronic
Hepatic Steatosis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Hepatic Steatosis on Prognosis and Outcomes of Patients With Chronic Hepatitis B

Resource links provided by NLM:


Further study details as provided by Fatty Liver and Alcoholic Liver Disease Study Group, China:

Primary Outcome Measures:
  • liver cirrhosis [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • liver cancer [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • liver failure [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • type 2 diabetes [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • cardiovascular and cerebrovascular events [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • death [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • response of hepatic steatosis to anti-virus treatment [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • effect of hepatic steatosis on HBeAg negativation among patients without anti-virus treatment [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • effect of hepatic steatosis on HBsAg negativation among patients without anti-virus treatment [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA
Liver tissue

Estimated Enrollment: 3000
Study Start Date: August 2015
Estimated Study Completion Date: December 2020
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Detailed Description:
This is a multicenter, prospective and open-enrollment epidemiologic study. All the patients with chronic hepatisis B will be enrolled in the study and followed up after 1 year, 3 years and 5 years with a visit window of +1 month.
  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any patients with chronic hepatisis B meeting eligibility criteria
Criteria

Inclusion Criteria:

  1. Clinically diagnosed chronic hepatitis B.
  2. Specific biopsy requirements for hepatic steatosis: qualified biopsy specimen within 6 months, >5% hepatocytes show macrovesicular steatosis under HE staining and X10 microscope.
  3. Willing to participate in the long-term follow-up and cooperative.
  4. Able to provide informed consent file.

Exclusion Criteria:

  1. Unable to provide informed consent.
  2. Patients are eligible for baseline analysis but not eligible for follow-up, if having any of the following condition:

    1. Any end-stage liver disease.
    2. Any malignant tumor.
    3. Any congenital liver disease such as Wilson disease.
    4. Any other serious disease of projected survival < 5 years.
  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: NCT02392598

Contacts
Contact: Jiangao Fan, MD fattyliver2004@126.com
Contact: Shiyan Yan, MD shyyan2008phd@yahoo.com

Locations
China, Fujian
Zhangzhou Zhengxing Hospital Not yet recruiting
Zhangzhou, Fujian, China
Contact: Ruidan Zheng, MD         
Principal Investigator: Ruidan Zheng, MD         
China, Shandong
Shandong Provincial Hospital Not yet recruiting
Ji'nan, Shandong, China
Contact: Wanhua Ren, MD         
Principal Investigator: Wanhua Ren, MD         
China, Sichuan
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital Not yet recruiting
Chengdu, Sichuan, China
Contact: Liangping Li, MD         
Principal Investigator: Liangping Li, MD         
China, Tianjin
Tianjin Second People's Hospital Not yet recruiting
Tianjin, Tianjin, China
Contact: Yuqiang Mi, MD         
Principal Investigator: Yuqiang Mi, MD         
China, Xinjiang
The First Affiliated Hospital of Xinjiang Medical University Not yet recruiting
Urumqi, Xinjiang, China
Contact: Fangping He, MD         
Principal Investigator: Fangping He, MD         
China, Zhejiang
The Affiliated Hospital of Hangzhou Normal University Not yet recruiting
Hangzhou, Zhejiang, China
Contact: Junping Shi, MD         
Principal Investigator: Junping Shi, MD         
China
Shanghai Xinhua Hospital Not yet recruiting
Shanghai, China
Contact: Jiangao Fan, MD       fattyliver2004@126.com   
Sponsors and Collaborators
Fatty Liver and Alcoholic Liver Disease Study Group, China
Unimed Scientific Inc.
Investigators
Principal Investigator: Jiangao Fan, MD Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
  More Information

Responsible Party: Fatty Liver and Alcoholic Liver Disease Study Group, China
ClinicalTrials.gov Identifier: NCT02392598     History of Changes
Other Study ID Numbers: HBV2015 
Study First Received: March 13, 2015
Last Updated: August 3, 2015
Health Authority: China: National Health and Family Planning Commission

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

ClinicalTrials.gov processed this record on September 30, 2016