A study to determine how safe and effective the treatment is for patients diagnosed with hepatitis B. The study will also look at how the body breaks-down the drug. The patients need to be already receiving Nucleoside Analogue Therapy, and have no evidence of liver damage.
- Conditions
- Hepatitis B virus e-antigen (HBeAg)-negative and HBeAg-positive subjects with chronic Hepatitis B virus (HBV)MedDRA version: 20.0Level: LLTClassification code 10054283Term: HBV DNA detectableSystem Organ Class: 100000004848Therapeutic area: Diseases [C] - Virus Diseases [C02]
- Registration Number
- EUCTR2015-005136-18-GB
- Lead Sponsor
- Arbutus Biopharma Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 46
1. Documented chronic HBV infection for =12 months prior to Screening Visit.
2. Quantitative HBV surface antigen (HBsAg) =1000 IU/mL by Elecsys HBsAg II (Roche) or Architect HBsAg QT (Abbott) at the Screening Visit. Subjects with HBsAg levels <1000 IU/mL and =250 IU/mL may be eligible after consultation with, and approval by, the Sponsor’s Medical Monitor.
3. Subjects currently receiving NA therapy:
a. Have been receiving entecavir and/or tenofovir for =12 months.
b. HBV DNA negative (below the lower limit of quantification [LLOQ]).
4. Historical HBeAg status from >3 months prior to the Screening Visit available for review.
5. All subjects must have a Fibroscan® result of =9 kPa at the Screening assessment.
6. Adult subjects, 18 (or other appropriate age of consent) to 70 years of age, inclusive.
7. Body mass index (BMI) =18 kg/m2 and =35 kg/m2.
8. Ability to review and agree to the nature of the study, and sign the informed consent document and comply with all protocol-specified visit schedules and requirements.
9. Female subjects of child-bearing potential must not be pregnant or lactating, must have a negative pregnancy test at Screening and must be
practicing an adequate method of birth control. Male subjects with female partners of child-bearing potential must also practice an adequate method of birth control. Refer to the protocol for additional details.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6
1. Known co-infection with any of the following:
a. Human immunodeficiency virus (HIV),
b. Hepatitis C virus (HCV)
c. Hepatitis D virus (HDV); OR
d. Hepatitis E virus (HEV).
2. Treatment with any investigational drug or enrollment in any other clinical study =3 months prior to the first dose of study treatment, or at any time during participation in the study; or collection of additional blood, urine, or tissue samples beyond those specified in this study or required as part of the subject’s medical care.
3. Receiving or planning to receive systemic immunosuppressive medications during the study or =2 months prior to the first dose of study treatment, including but not limited to: prednisone (>10 mg/day), methotrexate, or cyclosporine.
4. Receiving or planning to receive interferon during the study or =12 months prior to the first dose of study treatment.
5. Significant immunosuppression from, but not limited to immunodeficiency conditions such as common variable hypogammaglobulinemia.
6. Clinical diagnosis of substance abuse with alcohol, narcotics, or cocaine =12 months prior to the Screening Visit, except for those subjects monitored in an opioid substitution maintenance program.
7. Any known pre-existing medical or psychiatric condition that could interfere with the subject’s ability to provide informed consent or participate in study conduct, or that may confound study findings including, but not limited to:
a. Immunologically-mediated disease e.g., inflammatory bowel disease (Crohn’s disease, ulcerative colitis), rheumatoid arthritis, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, scleroderma, or sarcoidosis.
b. Current or history of any clinically significant cardiac abnormalities/dysfunction e.g., congestive heart failure, myocardial infarction =6 months prior to the Screening Visit, pulmonary hypertension, complex congenital heart disease, significant arrhythmia, active cardiac ischemia.
c. Current uncontrolled hypertension or past medical history of hypertensive crisis.
d. Evidence of decompensated liver disease including, but not limited to, a history or presence of clinical ascites, bleeding esophageal varices, hepatorenal syndrome, or hepatic encephalopathy.
e. Clinically unstable medical condition =1 week prior to the first dose of study treatment.
f. Psychiatric condition(s), including but not limited to suicidal or homicidal ideation and/or attempt.
8. Poor venous access that precludes routine peripheral blood sampling or intravenous (IV) infusion required for this study.
9. Evidence of active or suspected malignancy, or a history of malignancy, =3 years prior to the Screening Visit (except adequately treated carcinoma in situ and basal cell carcinoma of the skin). Subjects under evaluation for malignancy are not eligible.
10. Known or suspected hypersensitivity or previous severe reactions to any of the constituents of ARB-001467, other lipid-based products, or
products containing polyethylene glycol or the drugs used in the pre-treatment regimen (dexamethasone, ibuprofen, H1 and H2 blockers).
11. Pregnant or nursing, or who intend to become pregnant during the study.
12. Male subjects with partners who are, or intend to become, pregnant during the study.
13. Employed as site personnel directly involved with this study.
14. History of life-threatening SAE during the Screening period.
Laboratory Exclusion Criteria
If any of the following laboratory exclusion criteria are met, then the site may have t
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method