A clinical trial to continue to assess a novel medicine in the treatment of patients with Chronic Hepatitis B Virus (HBV) Infection (follow-on study from previous study)
- Conditions
- Chronic Hepatitis B Virus InfectionMedDRA version: 19.0Level: PTClassification code 10008910Term: Chronic hepatitis BSystem Organ Class: 10021881 - Infections and infestationsTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2014-004201-33-DE
- Lead Sponsor
- Arrowhead Research Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 120
1. Patients who showed a ½ log or greater reduction in serum HBsAg levels from baseline to day 71 ± 3 or day 99 ± 3 of the primary Heparc-2002 and Heparc-2003 studies.
2. Patients who receive their first dose within 2 months of their day 113 end-of-study visit of the primary Heparc-2002 and Heparc-2003 studies.
3. Able to provide written informed consent prior to the performance of any study specific procedures.
4. Have no abnormalities in 12-lead ECG assessment (measured after the patient is supine for at least 3 minutes) that, in the opinion of the principal investigator, may compromise patient’s safety in this study.
5. Willing and able to comply with all study assessments and adhere to the protocol schedule.
6. Have no new abnormal finding of clinical relevance at the screening evaluation.
7. Must be HBsAg (+).
8. HBV DNA < 200 IU/mL.
9. Patients must use 2 effective methods of contraception (double barrier contraception or hormonal contraceptive along with a barrier contraceptive) (both male and female partners) during the study and for 3 months following the last study treatment (ARC-520).
NOTE: Heparc-2002/2003 Day 85 or after assessments may be used to support entry into Heparc-2007, as applicable, as long as the assessment was done no more than 60 days prior to screening.
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 108
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 12
1. Female patients have a positive pregnancy test or are lactating.
2. Acute signs of hepatitis/other infection (eg, moderate fever, jaundice, nausea, vomiting, and abdominal pain) evident within 4 weeks of screening and/or at the screening examination.
3. Hepatic transaminases (ALT or AST) > 5X upper limits of normal.
4. Use of prescription medication (including anticoagulants) within 14 days prior to administration of study treatment except for topical products without systemic absorption, statins (except rosuvastatin), hypertensive medications, or hormonal contraceptives (females).
5. Patients with any of the following laboratory abnormalities:
-a. Serum creatinine > 1.5 mg/dL (132.6 µmol/L)
-b. International normalized ratio (INR) > 1.25 × ULN
-c. Platelets < 70,000 cells per mL
6. Patients with a mean Fridericia corrected interval between the start of the Q wave and the end of the T wave (QTcF) > 450 msec for males and > 470 msec for females.
7. Has had major surgery within 3 months of screening.
8. Has evidence of severe systemic acute inflammation, sepsis, or hemolysis.
9. Diagnosed with a significant psychiatric disorder that would prevent participation in the study.
10. Unable or unwilling to return for all scheduled study visits.
11. Has any other condition that, in the opinion of the principal investigator, would render the patient unsuitable for enrolment, or could interfere with his/her participation in the study.
NOTE: Heparc-2002/2003 Day 85 or after assessments may be used to support entry into/exclusion from Heparc-2007, as applicable, as long as the assessment was done no more than 60 days prior to screening.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine the percentage of initial responders to ARC-520 therapy achieving a 1-log reduction in HBsAg at week 36 of the extension study compared to baseline. Baseline is defined as the average of the pre-dose values in the primary Heparc-2002 and Heparc-2003 studies.;Primary end point(s): Change from baseline (mean of pre-dose values) to Day 113 in log qHBsAg following administration of ARC-520 by dose and treatment group;Timepoint(s) of evaluation of this end point: Day 113;Secondary Objective: • To determine the incidence and frequency of adverse events possibly or probably related to treatment as a measure of safety and tolerability of ARC-520 when co-administered with a fixed dose of entecavir or tenofovir in patients with chronic HBV infection.<br>• To determine the percentage of initial responders achieving HBsAg loss (qualitative HBsAg) at weeks 36, 48 and 60.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Change from baseline in log qHBsAg by treatment and dose for each timepoint.;Timepoint(s) of evaluation of this end point: Each visit