Ignite Creation Date:
2025-12-18 @ 8:27 AM
Ignite Modification Date:
2025-12-23 @ 10:51 PM
Study NCT ID:
NCT01610115
Status:
None
Last Update Posted:
2012-06-01 00:00:00
First Post:
2012-05-30 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
HBV DNA Levels During Pregnancy in Chronic Hepatitis B
Sponsor:
None
Organization:
Study Overview
Official Title:
Serial HBV DNA Levels During Pregnancy in Patients With Chronic Hepatitis B: a Prospective Observational Follow-up Study
Status:
None
Status Verified Date:
2012-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a prospective observational follow-up study in a single center.
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: