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

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ClinicalTrials.gov Identifier: NCT02738008
Recruitment Status : Terminated (Company decision to discontinue trial)
First Posted : April 14, 2016
Last Update Posted : June 27, 2017
Sponsor:
Information provided by (Responsible Party):
Arrowhead Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Hepatitis B Drug: ARC-520 Injection Phase 2

Detailed Description:

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/Heparc-2003 studies and responded to therapy are eligible to participate. Patients who have signed a Human Research Ethics Committee approved informed consent and have met all of the protocol eligibility criteria will continue receiving daily oral entecavir or tenofovir and IV injections of ARC-520. Study visits will occur once every 4 weeks for a total of 9 visits for monitoring and ARC-520 administration .

Patients will undergo the following evaluations at regular intervals during the study: medical history, physical examinations, vital sign measurements (blood pressure, heart rate, respiratory rate and temperature), weight, adverse events (AEs), 12-lead electrocardiogramss (ECGs), concomitant medications, blood sample collection for hematology, coagulation, chemistry, creatine kinase, troponin, hemoglobin A1c, exploratory pharmacodynamic (PD) measures, urinalysis, HBV serology, immunogenicity, and pregnancy testing for females of childbearing potential. Patients will be monitored for HBV virology, AEs, and exploratory PD measures for a total of 24 weeks after the last dose of ARC-520.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Extension Study of the Safety and Efficacy of Multi-dose Intravenous ARC-520 in Combination With Entecavir or Tenofovir in Patients With Chronic Hepatitis B Virus (HBV) Infection
Study Start Date : November 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ARC-520 Injection
Multiple administrations of ARC-520 starting at a dose level of 2 mg/kg
Drug: ARC-520 Injection
Intravenous injection




Primary Outcome Measures :
  1. Percentage of initial responders to ARC-520 therapy achieving a 1-log reduction in Hepatitis B Surface Antigen (HBsAg) as a measure of efficacy [ Time Frame: Baseline through Week 36 ]

Secondary Outcome Measures :
  1. Incidence and frequency of adverse events (AEs) as a measure of the safety and tolerability of ARC-520 [ Time Frame: Through Week 36 ]
  2. Percentage of initial responders to ARC-520 therapy with HBsAg loss (qualitative) compared to baseline [ Time Frame: At weeks 36, 48 and 60 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient showed a ½ log or greater reduction in serum HBsAg levels from baseline to day 71 ± 3 or day 99 ± 3 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02738008


Locations
Korea, Republic of
Pusan National University Hospital
Busan, Korea, Republic of, 602-739
Gachon University Gil Medical Center
Incheon, Korea, Republic of, 405-760
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Severance Hospital, Yonsei University College of Medicine
Seoul, Korea, Republic of, 120-752
Sponsors and Collaborators
Arrowhead Pharmaceuticals

Responsible Party: Arrowhead Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02738008     History of Changes
Other Study ID Numbers: Heparc-2007
2014-004201-33 ( EudraCT Number )
First Posted: April 14, 2016    Key Record Dates
Last Update Posted: June 27, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections