HBV DNA Levels During Pregnancy in Chronic Hepatitis B

Pregnancy Clinical Trial

Official title:

Serial HBV DNA Levels During Pregnancy in Patients With Chronic Hepatitis B: a Prospective Observational Follow-up Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01610115
• Other study ID #: HBV-P-01
• Status: Recruiting
• Phase: N/A
• First received: May 30, 2012
• Last updated: May 30, 2012
• Start date: January 2012
• Est. completion date: December 2014

Study information

• Verified date: May 2012
• Source: Chang Gung Memorial Hospital
• Contact: Mei-Hsia Ku
• Phone: 886-3-3281200
• Email: kuvicky1029[@]gmail.com
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic
• Hepatitis, Chronic
• Pregnancy

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan,