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

NCT02523547 | Unknown Phase 4

• 1 other identifier: HM-CAV-401
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Hepatitis B

Keywords

entecavir

Outcome Measures

Primary Outcomes (1)

• The proportion of patients with maintenance of HBV DNA undetectability

  analysis

  48weeks

Secondary Outcomes (9)

• The proportion of patients with HBeAg seroconversion

  at week 12, 24, 36 and 48 of treatment

• The proportion of patients with HBeAg seroclearance

  at week 12, 24, 36 and 48 of treatment

• The proportion with HBsAg seroclearance

  at week 48 of treatment

• The proportion with HBeAg seroconversion and HBsAb positive

  at week 48 of treatment

• Changes in serum HBV DNA levels

  at week 48 of treatment

Study Arms (2)

Cavir

EXPERIMENTAL

entecavir/0.5mg/day

Drug: Cavir

Baraclude

ACTIVE COMPARATOR

entecavir/0.5mg/day

Drug: Baraclude

Interventions

Cavir DRUG

0.5mg/day

Also known as: entecavir

Cavir

Baraclude DRUG

0.5mg/day

Also known as: entecavir

Baraclude

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hanmi Pharmaceutical Company Limited: lead

Study Sites (1)

15 Sites

Seoul, South Korea

RECRUITING

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

entecavir

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Hanmi Pharmaceutical

CONTACT

EunSol Kim

CONTACT

+82-2-410-8747; snow-white@hanmi.co.kr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2015
• First Posted: August 14, 2015
• Study Start: January 1, 2015
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: August 14, 2015

Record last verified: 2015-08

Locations

KR (1)