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
  Purpose

To elucidate the natural course of chronic hepatitis B by serial HBV DNA and alanine aminotransferase (ALT) levels during pregnancy


Condition
Hepatitis B
Pregnancy

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Serial HBV DNA Levels During Pregnancy in Patients With Chronic Hepatitis B: a Prospective Observational Follow-up Study

Resource links provided by NLM:


Further study details as provided by Chang Gung Memorial Hospital:

Estimated Enrollment: 100
Study Start Date: January 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Detailed Description:

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
  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
  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
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01610115

Contacts
Contact: Mei-Hsia Ku 886-3-3281200 ext 8114 kuvicky1029@gmail.com
Contact: Yi-Cheng Chen 886-3-3281200 ext 8107 yichengliver@gmail.com

Locations
Taiwan
Chang Gung Memorial Hospital Recruiting
Taoyuan, Taiwan
Contact: Mei-Hsia Ku    03281200 ext 8114    kuvicky1029@gmail.com   
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Principal Investigator: Yi-Cheng Chen, MD Chang Gung Memorial Hospital
  More Information

No publications provided

Responsible Party: Yi-Cheng Chen, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01610115     History of Changes
Other Study ID Numbers: HBV-P-01
Study First Received: May 30, 2012
Last Updated: May 30, 2012
Health Authority: Taiwan: Institutional Review Board

Keywords provided by Chang Gung Memorial Hospital:
Pregnancy

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on October 01, 2014