HBV DNA Levels During Pregnancy in Chronic Hepatitis B NCT01610115

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number	NCT01610115
Other study ID #	HBV-P-01
Secondary ID
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

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,

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HBV DNA Levels During Pregnancy in Chronic Hepatitis B

Clinical Trial Details — Status: Recruiting

Administrative data

Study information

Clinical Trial Summary

Description:

Recruitment information / eligibility

Study Design

Related Conditions & MeSH terms

Locations

Sponsors (1)

Country where clinical trial is conducted