Prospective Stuy in Evaluating Hepatic Fibrosis Related to Hepatitis B Virus Using Non-invasive Parameters (HBV)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Peking University First Hospital
Sponsor:
Information provided by (Responsible Party):
Guiqiang Wang, Peking University First Hospital
ClinicalTrials.gov Identifier:
NCT01962155
First received: October 5, 2013
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

The aim of our prospective study is to construct and validate a non-invasive model consisting biochemical markers, FibroScan, and radiological parameters for evaluating liver fibrosis caused by hepatitis B virus in mainland China.


Condition
Hepatitis B
Liver Fibrosis

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Weeks
Official Title: Prospective Stuy in Evaluating Hepatic Fibrosis Related to Hepatitis B Virus

Resource links provided by NLM:


Further study details as provided by Peking University First Hospital:

Primary Outcome Measures:
  • determine whether a non-invasive test or a combination of non invasive tests may be used to accurately evaluate liver fibrosis in patients with chronic hepatitis B [ Time Frame: singular evaluation at the time of liver biopsy ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

liver biopsy samples and blood samples


Estimated Enrollment: 2000
Study Start Date: August 2013
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
chronic infected with hepatitis B virus
patients infected with hepatitis B virus for at least 6 months and agreed with liver biopsy

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

patients infected with hepatitis B virus for at least 6 months

Criteria

Inclusion Criteria:

  1. HBsAg positive for at least 6 months
  2. agree to have liver biopsy
  3. Male or female aged 18 to 65 years old

Exclusion Criteria:

  1. Patients with alcoholic liver disease, autoimmune liver disease, heretic liver disease, drug induced liver disease,nonalcoholic liver disease or other chronic liver disease
  2. platelet count < 80000/L
  3. prothrombin activity ≤ 60%
  4. patients with any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject
  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: NCT01962155

Contacts
Contact: Guiqiang Wang 13911405123 john131212@126.com
Contact: Hong Zhao 13810765943 minmin2001@gmail.com

  Show 30 Study Locations
Sponsors and Collaborators
Peking University First Hospital
Investigators
Principal Investigator: Guiqiang Wang Peking University First Hospital
  More Information

No publications provided

Responsible Party: Guiqiang Wang, MD, Peking University First Hospital
ClinicalTrials.gov Identifier: NCT01962155     History of Changes
Other Study ID Numbers: 2013ZX10002005
Study First Received: October 5, 2013
Last Updated: April 14, 2014
Health Authority: China: Ministry of Health

Keywords provided by Peking University First Hospital:
Fibrosis
Liver Cirrhosis
non-invasive
biopsy
hepatitis B virus

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

ClinicalTrials.gov processed this record on October 21, 2014