Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
100 participants
OBSERVATIONAL
2012-01-31
2014-12-31
Brief Summary
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Detailed Description
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Number of patients: It is estimated to enroll 100 patients in Taiwan.
Population:
Female patients with pregnancy confirmed, at least 20 years of age diagnosed with chronic hepatitis B. The patients are able to communicate well, provide informed consent and willing to participate in the entire study.
Inclusion criteria:
Patients must meet all of the following 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
3. Willing and able to comply with all the requirements in the observational followup study
4. Willing and able to provide written informed consent to participate in the study
Exclusion criteria:
Patients will be excluded from the study for any of the following reasons:
1. Concurrent infection with hepatitis C virus (HCV), hepatitis D virus (HDV) or human immunodeficiency virus (HIV)
2. 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).
3. 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.
4. Enrolled or planning to enroll in another clinical trial of an investigational agent while participating in this study.
5. Patients with antiviral therapy to chronic hepatitis B
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
2. Female 20 years of age with confirmed pregnancy
3. Willing and able to comply with all the requirements in the observational follow-up study
4. Willing and able to provide written informed consent to participate in the study
Exclusion Criteria
2. 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).
3. 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.
4. Enrolled or planning to enroll in another clinical trial of an investigational agent while participating in this study.
5. Patients with antiviral therapy to chronic hepatitis B
20 Years
50 Years
FEMALE
No
Sponsors
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Chang Gung Memorial Hospital
OTHER
Responsible Party
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Yi-Cheng Chen
Yi-Cheng Chen
Principal Investigators
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Yi-Cheng Chen, MD
Role: PRINCIPAL_INVESTIGATOR
Chang Gung Memorial Hospital
Locations
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Chang Gung Memorial Hospital
Taoyuan District, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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HBV-P-01
Identifier Type: -
Identifier Source: org_study_id
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