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Hepatitis B, ChronicPhase 2NCT04289987

A Study to Evaluate the Efficacy and Safety of Therapeutic Hepatitis B Vaccine

A Phase 2 study testing CVI-HBV-002 in people with Hepatitis B, Chronic, run by Aribio Lab Co., Ltd. at 9 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 19 to 60 years
Conditions the study is for
Hepatitis B, Chronic
What is being tested?
CVI-HBV-002
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
134 participants
Where
9 sitesSouth Korea
Study dates
19 Feb 2020to 4 Dec 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 34Show fewer
  • 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
  • A history of ascites, jaundice, varicoses vein bleeding, hepatic encephalopathy, or other signs of liver failure
  • Treated with oral antiviral agents or interferon therapy other than TDF(or TD)
  • In case of receiving nephroxic drugs(Aminoglycosides, Amphotericin B, NSAIDs, etc.) within 14 days prior to screening
  • When hepatotoxic drugs(Erythromycin, Ketoconazole, Rifampin, Fluconazole, Dapsone, etc.) are administered within 14 days prior to screening
  • Patients with active bacterial, viral or fungal infections requiring systemic treatment
  • Patients diagnosed with Alpha-fetoprotein (AFP) >50 ng/mL or with Hepatocellular Carcinoma (HCC) in screening
  • 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
  • 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.
  • 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)
  • Organ transplantation recipients
  • Patients with serious illnesses, such as heart failure, renal failure, and pancreatitis, other than liver disease
  • 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)
  • Patients with seizure disorders who require anticonvulsant therapy
  • HbA1c>7.5%
  • SBP≥140mmHg or DBP≥90mmHg
  • Patients infected with hepatitis C(HCV), hepatitis D(HDV) or human immunodeficiency virus(HIV)
  • A hypersensitivity or anaphylactic reaction to the components of the clinical trial drug or HBV vaccine components
  • Continued drinking(>21 units/week, 1 unit = 10g of pure alcohol) or alcohol dependence
  • 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)
  • 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
  • Patient who has potential to severe febrile or systemic reaction
  • 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
  • Others those who are considered to be difficult to perform the clinical trial by the judgment of the Investigator

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

South Korea9 sites

  • CHA University Bundang Medical Center

    Seongnam-si, Gyeonggi-do, 13496

  • Chung-ang University Hospital

    Seoul, Dongjak-gu, 06973

  • The Catholic University of Korea, Eunpyeong St. Mary's Hospital

    Seoul, Eunpyeong-gu, 03312

  • Samsung Medical Center

    Seoul, Gangnam-gu, 06351

  • Korea University Guro Hospital

    Seoul, Guro-gu, 08308

  • Seoul National University Hospital

    Seoul, Jongno-gu, 03080

  • Severance Hospital

    Seoul, Sedaemun-gu, 03722

  • Asan Medical Center

    Seoul, Songpa-gu, 05505

  • Soon Chung Hyang University Hospital Seoul

    Seoul, Yongsan-gu, 04401

Other trials in South Korea

About this study

Official title: 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

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

Read the 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

Being tested
CVI-HBV-002, Normal Saline(placebo)
Medical subject headings
Hepatitis B, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CVI-HBV-002Biological

    Investigational Product

  • Normal Saline(placebo)Biological

    Investigational Product

Study groups in NCT04289987
Study groupRoleWhat they receive
CVI-HBV-002Experimental* CVI-HBV-002 1.0mL(20ug/dose) * Intramuscular injection at Baseline, Week 2, 4, 8, 12, 16, 20 / total 7 doses
Receives: Biological: CVI-HBV-002
Normal SalinePlacebo comparator* Normal Saline Choonwae Inj. 1.0 mL * Intramuscular injection at Baseline, Week 2, 4, 8, 12, 16, 20 / total 7 doses
Receives: Biological: Normal Saline(placebo)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: at week 48 from baseline

Secondary outcomes (8)

  1. 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

    Measured: at week 24 from baseline

  2. 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

    Measured: at weeks 24 and 48

  3. 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

    Measured: at weeks 24 and 48

  4. 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

    Measured: at Weeks 24 and 48

  5. 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

    Measured: at weeks 24 and 48

  6. Evaluation of changes in HBV specific T cell immunity

    Immune Response Rate of HBV specific T cell at Weeks 12 and 24 versus Baseline

    Measured: at weeks 12 and 24 from baseline

  7. Proportion assessment of Participants With Virologic breakthrough

    Proportion of subjects with experiencing virologic breakthrough

    Measured: Baseline to week 48

  8. Incidence assessment of Treatment-Emergent Adverse Evnent

    Safety and tolerability assessment through incidence of Treatment-Emergent Adverse Evnent after treatment of Investigational Product

    Measured: Baseline to Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2020
  2. Study start19 Feb 2020
  3. Primary completion4 Dec 2023
  4. Study completion4 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
134 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04289987
Sponsor's protocol ID
CVI-HBV-002-CT1901
Status last verified
Feb 2024
First submitted
22 Feb 2020
Last updated
13 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CVI-HBV-002 in people with Hepatitis B, Chronic, run by Aribio Lab Co., Ltd. at 9 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of Mean Change in HBsAg(log10 IU/mL) (time frame: at week 48 from baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04289987.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2024.

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