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

NCT02738008 | Terminated Phase 2 Results DMC

• 2 other identifiers: Heparc-20072014-004201-33
• Study Type: interventional
• Target: 12
• Locations: 3 countries
• Sites: 6

Brief Summary

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

Conditions

Hepatitis B

Outcome Measures

Primary Outcomes (1)

• Percentage of Initial Responders to ARC-520 Therapy Achieving a 1-log Reduction in HBsAg at Week 36 Compared to Baseline

  Initial responders are defined as participants who showed a ½ log or greater reduction in their serum HBsAg levels from baseline to Day 71 ± 3 days of the primary Heparc-2002 and Heparc-2003 studies, where baseline is defined as the average of pre-dose values.

  Baseline, Week 36

Secondary Outcomes (2)

• Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

  From first dose of study drug up to 28 weeks of treatment, plus up to 24 weeks of follow-up

• Percentage of Initial Responders to ARC-520 Therapy With HBsAg Loss (Qualitative) Compared to Baseline Over Time

  Baseline, Weeks 36, 48, and 60

Study Arms (1)

ARC-520 Injection

EXPERIMENTAL

Multiple administrations of ARC-520 starting at a dose level of 2 mg/kg, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day)

Drug: ARC-520 Injection; Drug: entecavir; Drug: tenofovir; Drug: antihistamine

Interventions

ARC-520 Injection DRUG

IV injection

ARC-520 Injection

entecavir DRUG

All participants will take entecavir or tenofovir throughout the study. Participants will be instructed to take their medication daily.

ARC-520 Injection

tenofovir DRUG

All participants will take entecavir or tenofovir throughout the study. Participants will be instructed to take their medication daily.

ARC-520 Injection

antihistamine DRUG

All participants will be pretreated with an oral antihistamine. The antihistamine used should in general be an H1\>H2 receptor blocker and would include diphenhydramine 50 mg, cetirizine 10 mg, chlorpheniramine 8 mg or hydroxyzine 50 mg. The Investigator is free to choose any of these antihistamines available locally and consistent with their country's Marketing Authorisation.

ARC-520 Injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Arrowhead Pharmaceuticals: lead

Study Sites (6)

Research Site 1

Hong Kong, 999077, China

Location

Research Site 2

Leipzig, 04103, Germany

Location

Research Site 3

Busan, 602-739, South Korea

Location

Research Site 5

Incheon, 405-760, South Korea

Location

Research Site 4

Seoul, 110-744, South Korea

Location

Research Site 6

Seoul, 120-752, South Korea

Location

MeSH Terms

Conditions

Hepatitis B

Interventions

ARC-520; entecavir; Tenofovir; Histamine Antagonists

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Histamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs

Limitations and Caveats

The decision to discontinue development of ARC-EXl-containing programs was not due to any safety findings in clinical studies.

Results Point of Contact

• Title: Chief Operating Officer
• Organization: Arrowhead Pharmaceuticals, Inc.

626-304-3400

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2016
• First Posted: April 14, 2016
• Study Start: March 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: January 13, 2026
• Results First Posted: April 16, 2019

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1); KR (4); DE (1)