Status unknownNCT02523547Updated Aug 14, 2015

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

A Phase 4 interventional study of Cavir and Baraclude in Chronic Hepatitis B, sponsored by Hanmi Pharmaceutical Company Limited. Status unknown at 1 site in Korea, Republic of. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2015-08-14.

Sponsored by Hanmi Pharmaceutical Company Limited · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Aug 2015), so the status shown — last known as Recruiting — may be out of date.

Phase: Phase 4
Study type: Interventional
Enrollment: 134
Allocation: Randomized
Ages: 19 Years and older
Sex: All

Study summary

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

Read the detailed 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.

Conditions studied

Chronic Hepatitis B

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Keywords

entecavir

In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's planned enrollment of 134 is above the median of 100 across 1,886 interventional studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

Hanmi Pharmaceutical Company Limited is the lead sponsor of 188 studies on the registry; 10 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 6 (55%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 19 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 134 participants (estimated)

Study arms

Experimental
Cavir
entecavir/0.5mg/day
Drug: Cavir
Active comparator
Baraclude
entecavir/0.5mg/day
Drug: Baraclude

Interventions

DrugCavir
0.5mg/day
Also known as: entecavir
DrugBaraclude
0.5mg/day
Also known as: entecavir

What researchers measure

Primary outcomes

The proportion of patients with maintenance of HBV DNA undetectability
analysis
Time frame: 48weeks

Secondary outcomes

The proportion of patients with HBeAg seroconversion
analysis
Time frame: at week 12, 24, 36 and 48 of treatment
The proportion of patients with HBeAg seroclearance
analysis
Time frame: at week 12, 24, 36 and 48 of treatment
The proportion with HBsAg seroclearance
analysis
Time frame: at week 48 of treatment
The proportion with HBeAg seroconversion and HBsAb positive
analysis
Time frame: at week 48 of treatment
Changes in serum HBV DNA levels
analysis
Time frame: at week 48 of treatment
Changes in HBsAg titer
analysis
Time frame: at week 48 of treatment
Changes in ALanine amino Transferase (ALT)
analysis
Time frame: at week 48 of treatment
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
Time frame: at week 48 of treatment
Changes in EuroQoL Five Dimensions Questionnaire-3L(EQ-5D-3L)
questionnaire
Time frame: at week 48 of treatment

Study locations

1 of 1 sites recruiting

15 Sites
Seoul, Korea, Republic of
- MoonHwa Park, MD · Contact · moonwha.park@hanmi.co.kr · 8224109190
Recruiting

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 14, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02523547
Lead sponsor: Hanmi Pharmaceutical Company Limited
Responsible party: Sponsor
First posted: Aug 14, 2015
Start date: Jan 2015
Primary completion: Feb 2017 (estimated)
Completion: Feb 2017 (estimated)
Last update: Aug 14, 2015

Study contacts

Hanmi Pharmaceutical

Contact

EunSol Kim

Contact

snow-white@hanmi.co.kr

+82-2-410-8747

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.

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