Extension Study of the Safety and Efficacy of Multi-dose Intravenous ARC-520 in Patients With Chronic Hepatitis B (HBV) Infection

Launched by ARROWHEAD PHARMACEUTICALS · Apr 11, 2016

Keywords

ClinConnect Summary

Open-label, multi-center extension study of intravenous ARC-520 in combination with entecavir or tenofovir in patients with chronic HBV infection. Patients who successfully completed the Heparc-2002 (NCT02604199) and Heparc-2003 (NCT02604212) studies and responded to therapy are eligible to participate. Responders are defined as patients who showed a ½ log or greater reduction in their serum Hepatitis B Surface Antigen (HBsAg) levels from baseline to day 71 ± 3 days of the primary Heparc-2002 and Heparc-2003 studies. Patients who have signed a Human Research Ethics Committee approved inform...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient showed a ½ log or greater reduction in serum HBsAg levels from baseline to Day 71 ± 3 days or Day 99 ± 3 days in the primary Heparc-2002 or Heparc-2003 study.
• • Able to have first dose within 2 months of day 113 end-of-study visit in the primary Heparc-2002 or Heparc-2003 study.
• • Able to provide written informed consent prior to the performance of any study specific procedures.
• • Have no abnormalities in 12-lead ECG assessment that, in the opinion of the investigator, may compromise patient safety
• • Willing and able to comply with all study assessments and adhere to the protocol schedule.
• • Have no new abnormal finding of clinical relevance at the screening evaluation.
• • Using 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 dose of (ARC 520).
• Exclusion Criteria:
• • Pregnant or lactating.
• • Acute signs of hepatitis/other infection within 4 weeks of screening and/or at the screening examination.
• • Use of prescription medication (including anticoagulants) within 14 days prior to administration of ARC-520.
• • Has had major surgery within 3 months of screening.
• • Has evidence of severe systemic acute inflammation, sepsis, or hemolysis.
• • Diagnosed with a significant psychiatric disorder that would prevent participation in the study.
• • Unable or unwilling to return for all scheduled study visits.
• • Has any other condition that, in the opinion of the investigator, would render the patient unsuitable for enrollment, or could interfere with his/her participation in the study.