HBV DNA Levels During Pregnancy in Chronic Hepatitis B
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01610115|
Recruitment Status : Unknown
Verified May 2012 by Yi-Cheng Chen, Chang Gung Memorial Hospital.
Recruitment status was: Recruiting
First Posted : June 1, 2012
Last Update Posted : June 1, 2012
|Condition or disease|
|Hepatitis B Pregnancy|
This is a prospective observational follow-up study in a single center.
Number of patients: It is estimated to enroll 100 patients in Taiwan.
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.
Patients must meet all of the following criteria
- 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 followup study
- Willing and able to provide written informed consent to participate in the study
Patients will be excluded from the study for any of the following reasons:
- 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
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Serial HBV DNA Levels During Pregnancy in Patients With Chronic Hepatitis B: a Prospective Observational Follow-up Study|
|Study Start Date :||January 2012|
|Estimated Primary Completion Date :||December 2013|
|Estimated Study Completion Date :||December 2014|
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): NCT01610115
|Contact: Mei-Hsia Ku||886-3-3281200 ext email@example.com|
|Contact: Yi-Cheng Chen||886-3-3281200 ext firstname.lastname@example.org|
|Chang Gung Memorial Hospital||Recruiting|
|Contact: Mei-Hsia Ku 03281200 ext 8114 email@example.com|
|Principal Investigator:||Yi-Cheng Chen, MD||Chang Gung Memorial Hospital|