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HBV DNA Levels During Pregnancy in Chronic Hepatitis B

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2012 by Yi-Cheng Chen, Chang Gung Memorial Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01610115
First Posted: June 1, 2012
Last Update Posted: June 1, 2012
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.
Information provided by (Responsible Party):
Yi-Cheng Chen, Chang Gung Memorial Hospital
May 30, 2012
June 1, 2012
June 1, 2012
January 2012
December 2013   (Final data collection date for primary outcome measure)
Not Provided
Not Provided
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
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
To elucidate the natural course of chronic hepatitis B by serial HBV DNA and alanine aminotransferase (ALT) levels during 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.

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
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
  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
  • Hepatitis B
  • Pregnancy
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
100
December 2014
December 2013   (Final data collection date for primary outcome measure)

Inclusion 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 follow-up study
  4. Willing and able to provide written informed consent to participate in the study

Exclusion Criteria:

  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
Sexes Eligible for Study: Female
20 Years to 50 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
 
NCT01610115
HBV-P-01
No
Not Provided
Not Provided
Yi-Cheng Chen, Chang Gung Memorial Hospital
Chang Gung Memorial Hospital
Not Provided
Principal Investigator: Yi-Cheng Chen, MD Chang Gung Memorial Hospital
Chang Gung Memorial Hospital
May 2012