Skip to content

The development of predictive model for complete virologic response in chronic hepatitis B treated by antiviral drugs

The development of predictive model for complete virologic response in chronic hepatitis B treated by antiviral drugs

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0001872
Enrollment
82
Registered
2016-04-04
Start date
2016-05-06
Completion date
Unknown
Last updated
2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

Catholic Kwandong University International St.Mary's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
serum HBV DNA

Secondary

MeasureTime frame
serum ALT normalization;serum HBeAg loss;serum HBsAg loss

Countries

Korea, Republic of

Contacts

Public ContactSangheun Lee

Catholic Kwandong University International St.Mary's Hospital

medsinger@naver.com+82-32-290-3227

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026