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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04289987
Other study ID # CVI-HBV-002-CT1901
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date February 19, 2020
Est. completion date December 4, 2023

Study information

Verified date February 2024
Source CHA Vaccine Institute Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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


Recruitment information / eligibility

Status Completed
Enrollment 134
Est. completion date December 4, 2023
Est. primary completion date December 4, 2023
Accepts healthy volunteers No
Gender All
Age group 19 Years to 60 Years
Eligibility Inclusion Criteria: 1. Adult between 19 to 60 years of age 2. Those who have been diagnosed as chronic hepatitis B patients (e.g.HBsAg positive detected for 6 months or more) 3. Started treatment with Tenofovir Disoproxil Fumarate(TDF) or Tenofovir Diproxil(TD), oral HBV antiviral agent, for 6 months to 5 years. 4. HBsAg = 100 IU/mL, HBV DNA = 100 IU/mL at screening 5. HBV DNA = 2000 IU/mL at screening 6. ALT = Upper Limit of Normal) x 2 at screening 7. Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures Exclusion Criteria: 1. 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) 2. 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 3. A history of ascites, jaundice, varicoses vein bleeding, hepatic encephalopathy, or other signs of liver failure 4. Treated with oral antiviral agents or interferon therapy other than TDF(or TD) 5. In case of receiving nephroxic drugs(Aminoglycosides, Amphotericin B, NSAIDs, etc.) within 14 days prior to screening 6. When hepatotoxic drugs(Erythromycin, Ketoconazole, Rifampin, Fluconazole, Dapsone, etc.) are administered within 14 days prior to screening 7. Patients with active bacterial, viral or fungal infections requiring systemic treatment 8. Patients diagnosed with Alpha-fetoprotein (AFP) >50 ng/mL or with Hepatocellular Carcinoma (HCC) in screening 9. Of those who have received immunosuppressive drugs within 6 months prior to screening, patients suspected of having decreased immunity by the judgment of the Investigator 10. Patients who have received high dose (prednisone 20mg or more*) systemic corticosteroids for a long period of time(consecutive 14 days or longer) within 3 months before screening (at the discretion of the investigator in case of local corticosteroids) * Corresponding to 125 mg of cortisone, 100 mg of hydrocortisone, 20 mg of prednisone, 16 mg of methylpreprednisolone, 16 mg of triamsynolone, 3 mg of dexamethasone and 2.4 mg of betametasone. 11. Patients who have been diagnosed with malignant tumors within 5 years before screening, or who have recurred malignant tumors(in case of benign tumors, if the Investigator considers that the progress of the clinical trial is not affected during the clinical trial) 12. Organ transplantation recipients 13. Patients with serious illnesses, such as heart failure, renal failure, and pancreatitis, other than liver disease 14. Patients with a history of serious heart disease (NYHA Functional Class III or IV heart failure, myocardial infarction within 6 months, ventricular tachyarrhythmias requiring treatment or unstable angina) 15. Patients with seizure disorders who require anticonvulsant therapy 16. HbA1c>7.5% 17. SBP=140mmHg or DBP=90mmHg 18. Patients infected with hepatitis C(HCV), hepatitis D(HDV) or human immunodeficiency virus(HIV) 19. A hypersensitivity or anaphylactic reaction to the components of the clinical trial drug or HBV vaccine components 20. Continued drinking(>21 units/week, 1 unit = 10g of pure alcohol) or alcohol dependence 21. Pregnancy or breastfeeding, or cannot agree with the approved method of contraception of the patient and partner during the clinical trial(e.g., infertility surgery, intrauterine contraceptive, oral contraceptive and concomitant use of diaphragm or condom, other hormonal delivery systems and concomitant use of diaphragm or condom) 22. Patients who are concerned about the deterioration of daily function due to mental illness or who cannot understand the purpose and method of this trial 23. Patient who has potential to severe febrile or systemic reaction 24. Patients who are scheduled to participate in other clinical trials after enrolling in this trial, or have participated in other clinical trials within 3 month of enrollment in this trial 25. Others those who are considered to be difficult to perform the clinical trial by the judgment of the Investigator

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
CVI-HBV-002
Investigational Product
Normal Saline(placebo)
Investigational Product

Locations

Country Name City State
Korea, Republic of CHA University Bundang Medical Center Seongnam-si Gyeonggi-do
Korea, Republic of Asan Medical Center Seoul Songpa-gu
Korea, Republic of Chung-ang University Hospital Seoul Dongjak-gu
Korea, Republic of Korea University Guro Hospital Seoul Guro-gu
Korea, Republic of Samsung Medical Center Seoul Gangnam-gu
Korea, Republic of Seoul National University Hospital Seoul Jongno-gu
Korea, Republic of Severance Hospital Seoul Sedaemun-gu
Korea, Republic of Soon Chung Hyang University Hospital Seoul Seoul Yongsan-gu
Korea, Republic of The Catholic University of Korea, Eunpyeong St. Mary's Hospital Seoul Eunpyeong-gu

Sponsors (1)

Lead Sponsor Collaborator
CHA Vaccine Institute Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluation of Mean Change in HBsAg(log10 IU/mL) 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 at week 48 from baseline
Secondary Evaluation of Mean changes in serum HBsAg(log 10 IU/mL) To evaluate mean changes in serum HBsAg(log 10 IU/mL) for patients treated with CVI-HBV-002 or Placebo at Week 24 versus Baseline at week 24 from baseline
Secondary Proportion assessment of Participants With HBsAg loss To evaluate proportion of subjects with HBsAg loss for patients treated with CVI-HBV-002 or Placebo at Weeks 24 and 48 at weeks 24 and 48
Secondary Proportion assessment of Participants With HBsAg seroconversion To evaluate proportion of subjects with HBsAg seroconversion for patients treated with CVI-HBV-002 or Placebo at Weeks 24 and 48 at weeks 24 and 48
Secondary Proportion assessment of Participants With HBeAg loss To evaluate proportion of subjects with HBeAg loss for HBeAg positive patients treated with CVI-HBV-002 or Placebo at Weeks 24 and 48 at Weeks 24 and 48
Secondary Proportion assessment of Participants With HBeAg seroconversion To evaluate proportion of subjects with HBeAg seroconversion for HBeAg positive patients treated with CVI-HBV-002 or Placebo at Weeks 24 and 48 at weeks 24 and 48
Secondary Evaluation of changes in HBV specific T cell immunity Immune Response Rate of HBV specific T cell at Weeks 12 and 24 versus Baseline at weeks 12 and 24 from baseline
Secondary Proportion assessment of Participants With Virologic breakthrough Proportion of subjects with experiencing virologic breakthrough Baseline to week 48
Secondary Incidence assessment of Treatment-Emergent Adverse Evnent Safety and tolerability assessment through incidence of Treatment-Emergent Adverse Evnent after treatment of Investigational Product Baseline to Week 48
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