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Trial record 137 of 311 for:    hepatitis b | Recruiting, Not yet recruiting, Available Studies

REALM China Extension Study

This study is currently recruiting participants.
Verified November 2016 by Nanfang Hospital of Southern Medical University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02974829
First Posted: November 29, 2016
Last Update Posted: November 29, 2016
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.
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Nanfang Hospital of Southern Medical University
  Purpose
The purpose of this study is to conduct an investigator initiated observational study to continue to follow up the China subset of study participants for another 5 years after they complete participation in the REALM Study

Condition Intervention
Hepatitis B, Chronic Other: follow-up

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A 5-Year Follow-up Study of Subjects Who Completed REALM-China Study

Resource links provided by NLM:


Further study details as provided by Nanfang Hospital of Southern Medical University:

Primary Outcome Measures:
  • Treatment patterns in Study AI463520 [ Time Frame: year 5 ]
  • Incidence rates of hepatitis B virus (HBV)-related clinical outcome events (COEs), such as non-hepatocellular carcinoma (HCC) HBV progression, HCC, and liver-related mortality, in Studies AI463080 and AI463520 combined, and in Study AI463520. [ Time Frame: year 5 ]

Secondary Outcome Measures:
  • Antiviral efficacy endpoints on anti-HBV treatment in Studies AI463080 and AI463520. [ Time Frame: year 5 ]
  • Multivariate logistic regression models evaluating the relationship between pre-treatment biomarkers and antiviral efficacy endpoints on anti-HBV treatment in Study [ Time Frame: year 5 ]
  • Multivariate logistic regression models evaluating the relationship between baseline liver stiffness measurement (LSM) and HBV-related COEs outcomes in Study AI463520. [ Time Frame: year 5 ]

Estimated Enrollment: 4000
Study Start Date: May 2016
Estimated Primary Completion Date: January 2022 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
All patients
Continuing with marketed anti-HBV or off-treatment in real-life setting
Other: follow-up

  Eligibility

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
Chronic hepatitis B patients
Criteria

Inclusion Criteria:

  1. Patients completed REALM Study in China
  2. Patients willing to sign the consent to continue anti-viral treatment or post-treatment follow up, and agree his/her legacy data and blood/liver histology samples collected in REALM Study may be used for the analyses planned for this new study.

Exclusion Criteria:

  1. Patients who do not provide consent to participate in this study;
  2. Patients are formally enrolled into any investigational drug clinical trial after the REALM study.
  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): NCT02974829


  Show 50 Study Locations
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
Bristol-Myers Squibb
  More Information

Responsible Party: Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT02974829     History of Changes
Other Study ID Numbers: AI463520
First Submitted: November 23, 2016
First Posted: November 29, 2016
Last Update Posted: November 29, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Nanfang Hospital of Southern Medical University:
Chronic Hepatitis B

Additional relevant MeSH terms:
Hepatitis
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Hepatitis, Chronic