Efficacy and Safety of Vireal®(Tenofovir Disoproxil Orotate) in Chronic Hepatitis B Patients Previously Treated with Viread®(Tenofovir Disoproxil Fumarate)

Efficacy and Safety of Vireal®(Tenofovir Disoproxil Orotate) in Chronic Hepatitis B Patients Previously Treated with Viread®(Tenofovir Disoproxil Fumarate) : Multi-center, Open Label, Prospective, Investigator Initiative Study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0004185

Enrollment

Registered

2019-08-12

Start date

2019-09-16

Completion date

Unknown

Last updated

2019-08-26

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

Conditions

None listed

Interventions

Drug : Substitutive prescription of VIREAL® for 24 weeks to 64 patients who have taken VIREAD® for more than 48 weeks Prior treatment - more than 48 weeks VIREAD® (Tenofovir disoproxil fumarate), Gi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. age > 18 yrs 2. Patients who have taken VIREAD® for more than 48 weeks have less than 20 IU/mL of HBV DNA 3. HBeAg posive or negative 4. Patients who allow consent form and have a will for attendance for the study

Exclusion criteria

Exclusion criteria: 1. HCV, HDV, or HIV positive 2. Decompensated cirrhosis (more than 1 below items) - serum total bilirubin > 3 mg/dL _ serum albumin < 2.8 g/dL _ Prothrombin time prolongation more than 4 sec _ Ascites or jaundice _ The occurence of gastroesophageal varix bleeding or hepatic encephalopathy within 6 months 3. Patients who had liver transplantation 4. Diagnosis of HCC 5. Other malignancy 6. Corticosteroid or immune suppressant exposure more than 2 weeks within 3 months 7. Incontrollable DM 8. GFR increase more than 30% after tenofovir medication, or creatinine clearance < 50ml/min at baseline 9. galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption 10. Pregnancy

Design outcomes

Primary

Measure	Time frame
Maintained virologic response;adverse events;renal function;occurrence of hepatocellular carcinoma,;blood test,;physical examination/vital sign	—

Secondary

Measure	Time frame
HBV DNA change from Baseline (log10 IU/mL);The proportion of patients with normal ALT;HBeAg loss and/or seroconversion	—

Countries

Korea, Republic of

Contacts

Public ContactSoung Won Jeong

Soon Chun Hyang University Hospital Seoul

119dr@naver.com+82-2-710-3076

Outcome results