HBV DNA Levels During Pregnancy in Chronic Hepatitis B
Serial HBV DNA Levels During Pregnancy in Patients With Chronic Hepatitis B: a Prospective Observational Follow-up Study
1 other identifier
observational
100
1 country
1
Brief Summary
To elucidate the natural course of chronic hepatitis B by serial HBV DNA and alanine aminotransferase (ALT) levels during pregnancy
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2012
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 30, 2012
CompletedFirst Posted
Study publicly available on registry
June 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedJune 1, 2012
May 1, 2012
1.9 years
May 30, 2012
May 30, 2012
Conditions
Keywords
Eligibility Criteria
1. Documented chronic hepatitis B defined by clinical history compatible with chronic hepatitis B and detectable serum HBsAg 2. Female 20 years of age with confirmed pregnancy
You may qualify if:
- Documented chronic hepatitis B defined by clinical history compatible with chronic hepatitis B and detectable serum HBsAg
- Female 20 years of age with confirmed pregnancy
- Willing and able to comply with all the requirements in the observational follow-up study
- Willing and able to provide written informed consent to participate in the study
You may not qualify if:
- Concurrent infection with hepatitis C virus (HCV), hepatitis D virus (HDV) or human immunodeficiency virus (HIV)
- One or more known primary or secondary causes of liver disease other than hepatitis B (e.g., alcoholism, non-alcoholic steatohepatitis, autoimmune hepatitis, malignancy with hepatic involvement, hemochromatosis, alpha-1 antitrypsin deficiency, Wilson's disease, other congenital or metabolic conditions affecting the liver, congestive heart failure or other severe cardiopulmonary disease).
- Any other concurrent medical or psychosocial condition likely to preclude compliance with the schedule of evaluations in the protocol or likely to confound the efficacy or safety observations of the study.
- Enrolled or planning to enroll in another clinical trial of an investigational agent while participating in this study.
- Patients with antiviral therapy to chronic hepatitis B
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chang Gung Memorial Hospital
Taoyuan District, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yi-Cheng Chen, MD
Chang Gung Memorial Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Yi-Cheng Chen
Study Record Dates
First Submitted
May 30, 2012
First Posted
June 1, 2012
Study Start
January 1, 2012
Primary Completion
December 1, 2013
Study Completion
December 1, 2014
Last Updated
June 1, 2012
Record last verified: 2012-05