A Randomized, Double-blinded, Placebo-controlled, Parallel, Multicenter, Phase 2b Study to Evaluate the Efficacy and Safety of CVI-HBV-002 in Patients With Chronic Hepatitis B Taking Tenofovir

CHA Vaccine Institute Co., Ltd.9 sites in 1 country134 target enrollmentFebruary 19, 2020

ConditionsHepatitis B, Chronic

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Hepatitis B, Chronic
Sponsor: CHA Vaccine Institute Co., Ltd.
Enrollment: 134
Locations: 9
Primary Endpoint: Evaluation of Mean Change in HBsAg(log10 IU/mL)
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of the investigational medicinal product CVI-HBV-002.

Detailed Description

A randomized, double-blinded, placebo-controlled, parallel, multicenter, phase 2b study to evaluate the efficacy and safety of CVI-HBV-002 in patients with chronic hepatitis B taking Tenofovir disoproxil fumarate/Tenofovir disoproxil

Registry

clinicaltrials.gov

Start Date

February 19, 2020

End Date

December 4, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

CHA Vaccine Institute Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Adult between 19 to 60 years of age
•Those who have been diagnosed as chronic hepatitis B patients (e.g.HBsAg positive detected for 6 months or more)
•Started treatment with Tenofovir Disoproxil Fumarate(TDF) or Tenofovir Diproxil(TD), oral HBV antiviral agent, for 6 months to 5 years.
•HBsAg ≥ 100 IU/mL, HBV DNA ≤ 100 IU/mL at screening
•HBV DNA ≤ 2000 IU/mL at screening
•ALT ≤ Upper Limit of Normal) x 2 at screening
•Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures

Exclusion Criteria

•Patients with other hepatic disease other than chronic hepatitis B(e.g., hemochromatosis, Wilson disease, alcoholic liver disease, nonalcoholic steatohepatitis, alpha-1 antitrypsin deficiency, etc)
•If any of the following laboratory tests were found at screening
•Total bilirubin \> Upper Limit of Normal x 2
•Prothrombin time delayed more than 3 seconds than normal
•Serum Albumin \< 30 g/L (3 g/dL)
•Hemoglobin \< 9.0 g/dL eGFR \< 60 mL/min (Cockcroft-Gault)
•Absolute neutrophil count (ANC) \< 1.5 x 10\^9 /L (1500 /mm3)
•Platelet count \< 100 x 10\^9 /L (100 x 10\^3 /mm3)
•Serum creatinine \> 1.5 mg/dL
•Serum amylase \> 2 x ULN and Lipase \> 2 x ULN

Outcomes

Primary Outcomes

Evaluation of Mean Change in HBsAg(log10 IU/mL)

Time Frame: at week 48 from baseline

To evaluate mean changes in serum HBsAg(log 10 IU/mL) for patients treated with CVI-HBV-002 or Placebo at Week 48 versus Baseline

Secondary Outcomes

Evaluation of Mean changes in serum HBsAg(log 10 IU/mL)(at week 24 from baseline)
Proportion assessment of Participants With Virologic breakthrough(Baseline to week 48)
Incidence assessment of Treatment-Emergent Adverse Evnent(Baseline to Week 48)
Proportion assessment of Participants With HBsAg seroconversion(at weeks 24 and 48)
Proportion assessment of Participants With HBeAg loss(at Weeks 24 and 48)
Proportion assessment of Participants With HBsAg loss(at weeks 24 and 48)
Proportion assessment of Participants With HBeAg seroconversion(at weeks 24 and 48)
Evaluation of changes in HBV specific T cell immunity(at weeks 12 and 24 from baseline)