HBV DNA Levels During Pregnancy in Chronic Hepatitis B

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2012 by Chang Gung Memorial Hospital
Sponsor:
Information provided by (Responsible Party):
Yi-Cheng Chen, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01610115
First received: May 30, 2012
Last updated: NA
Last verified: May 2012
History: No changes posted

May 30, 2012
May 30, 2012
January 2012
December 2013   (final data collection date for primary outcome measure)
Not Provided
Not Provided
No Changes Posted
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Not Provided
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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
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Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
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
Female
20 Years to 50 Years
No
Contact: Mei-Hsia Ku 886-3-3281200 ext 8114 kuvicky1029@gmail.com
Contact: Yi-Cheng Chen 886-3-3281200 ext 8107 yichengliver@gmail.com
Taiwan
 
NCT01610115
HBV-P-01
No
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP