The development of predictive model for complete virologic response in chronic hepatitis B treated by antiviral drugs
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0001872
- Lead Sponsor
- Catholic Kwandong University International St.Mary's Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 82
1)The patients who visited St. International Mary's hospital, Catholic Kwandong University College of Medicine and diagnosed as chronic hepatitis B
2)more than 20 years old men or women
3)The patients who do not receive anti-viral agents for chronic hepatitis B before the clinical study.
4)The patients with chronic hepatitis B who was treated by tenofovir as an initial therapy
5)When tenofovir is required for the treatment of chronic hepatitis B and the condition of patients meet the selection criteria of the clinical study, we will ask for patient's absolute commitment. Then, we will select them as subjects after the agreement.
1) The patients infected by chronic hepatitis C, hepatitis D or human immunodeficiency virus
2) a pregnant or breast-feeding women or the pregnancy was confirmed by pregnancy test using serum or urine. The womeen who are planning to be pregnant during the clinical study or do not follow the approved contraceptive method.
3) the patients who were diagnosed as hepatocellular carcinoma or suspected as hepatocellular carcinoma through the examination of radiologic test or serum alphafeto-protein.
4) The patients with other liver disease (hematochromatosis, Wilson diseasee, Alcoholic liver disease, Non-alcoholic liver disteatosis, alpha-1 antitrypsin deficiency
5) The patients who have a history of hypersensitivity reaction for the medicinne or the contents of clinical study
6) The patients who joined other clinical study 60 days before they are registered in the current study.
7) When clinicians judge the clinical study participation is determined as unfit subjects
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method serum HBV DNA
- Secondary Outcome Measures
Name Time Method serum ALT normalization;serum HBeAg loss;serum HBsAg loss