Study to Evaluate the Non-inferiority of Cavir in HBeAg(+)Chronic Hepatitis B Patients Treated With Baraclude

Chronic Hepatitis B Clinical Trial

Official title:

PhaseIVstudy to Evaluate the Non-inferiority of Cavir®Tab. in Terms of Hepatitis B Virus(HBV)DNA Undetectability Comparing Baraclude® Tab. in Hepatitis B e Antigen(HBeAg)(+) Chronic Hepatitis B Patients Treated With Long-term Baraclude® Tab

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02523547
• Other study ID #: HM-CAV-401
• Status: Recruiting
• Phase: Phase 4
• First received: July 26, 2015
• Last updated: August 13, 2015
• Start date: January 2015
• Est. completion date: February 2017

Study information

• Verified date: August 2015
• Source: Hanmi Pharmaceutical Company Limited
• Contact: Hanmi Pharmaceutical
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial Summary

Open-labeled, Prospective, Randomized, Multi-center, Interventional, Phase IV study.

Description:

The purpose of this study is to evaluate the non-inferiority and safety in terms of HBV DNA undetectability comparing Baraclude Tab. in HBeAg(+) chronic hepatitis B patients treated with long-term Baraclude Tab.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 134
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Patients (over the19 years of age) currently taking Baraclude® monotherapy for chronic HBV infection for at least 24 month with < HBV DNA 60 IU/mL level, HBeAg positive and HBeAb negative status at screening.

Exclusion Criteria:

• Patients are diagnosed Hepatitis cancer and hepatocellular carcinoma (HCC)

• Patient has concomitant other chronic viral infection (HAV/Hepatitis C Virus (HCV)/Hepatitis D Virus(HDV)/HIV)

• Patient had documented resistance mutations at any time before or at screening

• Patient has clinically confirmed alcoholism, autoimmune hepatitis, malignancy with hepatic involvement, hemochromatosis, alpha-1 antitrypsin deficiency and Wilson's Disease.

• Patient has received antiviral agent including interferon other than Baraclude within 24 months before screening for this study.

• Patient has received immunosuppressive agent within 24 weeks before screening or corticosteroids for 4 weeks.

• Clinical signs as indicated by any one of the following: Ccr(Cockroft-Gault) < 50ml/min, Total bilirubin > 3.0 mg/dl, Albumin < 2.7 g/dl, Prothrombin time > INR 2.3

• Patient is pregnant or breastfeeding or willing to be pregnant

• Patient has malignancy except for thyroid cancer and Borderline malignancy.a history of treated malignancy is allowable if the patient's malignancy has been in complete remission, off chemotherapy and without additional surgical intervention, during the preceding five years

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• Cavir
0.5mg/day
• Baraclude
0.5mg/day

Locations

Country	Name	City	State
Korea, Republic of	15 Sites	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hanmi Pharmaceutical Company Limited

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of patients with maintenance of HBV DNA undetectability	analysis	48weeks	No
Secondary	The proportion of patients with HBeAg seroconversion	analysis	at week 12, 24, 36 and 48 of treatment	No
Secondary	The proportion of patients with HBeAg seroclearance	analysis	at week 12, 24, 36 and 48 of treatment	No
Secondary	The proportion with HBsAg seroclearance	analysis	at week 48 of treatment	No
Secondary	The proportion with HBeAg seroconversion and HBsAb positive	analysis	at week 48 of treatment	No
Secondary	Changes in serum HBV DNA levels	analysis	at week 48 of treatment	No
Secondary	Changes in HBsAg titer	analysis	at week 48 of treatment	No
Secondary	Changes in ALanine amino Transferase (ALT)	analysis	at week 48 of treatment	No
Secondary	Proportion of patients with virologic breakthrough	virologic breakthrough is defined as the increase in serum HBV DNA (>60IU/ml) as determined by at least 2 consecutive measurements of at least 3 month apart, during continued treatment	at week 48 of treatment	No
Secondary	Changes in EuroQoL Five Dimensions Questionnaire-3L(EQ-5D-3L)	questionnaire	at week 48 of treatment	No