Trial record 89 of 325 for:    hepatitis b | Recruiting, Not yet recruiting, Available Studies

A Hepatitis B With Hepatic Steatosis Study (HBHS)

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. Identifier: NCT02392598
Recruitment Status : Not yet recruiting
First Posted : March 19, 2015
Last Update Posted : August 5, 2015
Unimed Scientific Inc.
Information provided by (Responsible Party):
Fatty Liver and Alcoholic Liver Disease Study Group, China

Brief Summary:
This is an epidemiologic study on effect of hepatic steatosis on prognosis and outcomes of patients with chronic hepatitis B.

Condition or disease
Hepatitis B, Chronic Hepatic Steatosis

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.

Study Type : Observational
Estimated Enrollment : 3000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of Hepatic Steatosis on Prognosis and Outcomes of Patients With Chronic Hepatitis B
Study Start Date : August 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. liver cirrhosis [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. liver cancer [ Time Frame: 5 years ]
  2. liver failure [ Time Frame: 5 years ]
  3. type 2 diabetes [ Time Frame: 5 years ]
  4. cardiovascular and cerebrovascular events [ Time Frame: 5 years ]
  5. death [ Time Frame: 5 years ]
  6. response of hepatic steatosis to anti-virus treatment [ Time Frame: 1 year ]
  7. effect of hepatic steatosis on HBeAg negativation among patients without anti-virus treatment [ Time Frame: 1 year ]
  8. effect of hepatic steatosis on HBsAg negativation among patients without anti-virus treatment [ Time Frame: 1 year ]

Biospecimen Retention:   Samples With DNA
Liver tissue

Information from the National Library of Medicine

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

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 identifier (NCT number): NCT02392598

Contact: Jiangao Fan, MD
Contact: Shiyan Yan, MD

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         
Shanghai Xinhua Hospital Not yet recruiting
Shanghai, China
Contact: Jiangao Fan, MD   
Sponsors and Collaborators
Fatty Liver and Alcoholic Liver Disease Study Group, China
Unimed Scientific Inc.
Principal Investigator: Jiangao Fan, MD Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Responsible Party: Fatty Liver and Alcoholic Liver Disease Study Group, China Identifier: NCT02392598     History of Changes
Other Study ID Numbers: HBV2015
First Posted: March 19, 2015    Key Record Dates
Last Update Posted: August 5, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
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