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

• Status: Terminated
• Trial end date: 2016-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Chronic HBV patients will receive 9 doses of open-label ARC-520 once every 4 weeks and be evaluated for safety and efficacy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Arrowhead Pharmaceuticals
• Treatments: Entecavir; Histamine Antagonists; Histamine H1 Antagonists; Tenofovir

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.