Trial record 115 of 504 for:    hepatitis b | Open Studies

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by Arrowhead Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Arrowhead Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT02738008
First received: April 11, 2016
Last updated: NA
Last verified: April 2016
History: No changes posted
  Purpose
Chronic HBV patients will receive 9 doses of open-label ARC-520 once every 4 weeks and be evaluated for safety and efficacy.

Condition Intervention Phase
Hepatitis B
Drug: ARC-520 Injection
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Arrowhead Pharmaceuticals:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incidence and frequency of adverse events (AEs) as a measure of the safety and tolerability of ARC-520 [ Time Frame: Through Week 36 ] [ Designated as safety issue: Yes ]
  • Percentage of initial responders to ARC-520 therapy with HBsAg loss (qualitative) compared to baseline [ Time Frame: At weeks 36, 48 and 60 ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: April 2016
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ARC-520 Injection
Multiple administrations of ARC-520 starting at a dose level of 2 mg/kg
Drug: ARC-520 Injection
Intravenous injection

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02738008

Contacts
Contact: Medical Monitor 626-304-3400

Locations
Korea, Republic of
Pusan National University Hospital Recruiting
Busan, Korea, Republic of, 602-739
Contact: Hye Young Lee    82 512407869    prettyoung97@daum.net   
Principal Investigator: Jeong Heo, MD         
Sub-Investigator: Hyun Young Woo         
Gachon University Gil Medical Center Recruiting
Incheon, Korea, Republic of, 405-760
Contact: Sun Hwa Lee    82 1063758434    sunhwa.lee@gilhospital.com   
Principal Investigator: Ju Hyun Kim, MD         
Sub-Investigator: Duck Joo Choi         
Sub-Investigator: Yun Soo Kim         
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Jin Hee Kim    82 220722228    dadas3178@naver.com   
Principal Investigator: Jung-Hwan Yoon, MD         
Sub-Investigator: Jeong-Hoon Lee         
Severance Hospital, Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of, 120-752
Contact: Sin Ok Ki    82 2 312 4725    shinok74@yuhs.ac   
Contact: Sunjin Chung    82 2228 0525    archrose@yuhs.ac   
Principal Investigator: Sang Hoon Ahn, MD         
Sub-Investigator: Do Young Kim         
Sub-Investigator: Seung Up Kim         
Sponsors and Collaborators
Arrowhead Pharmaceuticals
  More Information

Responsible Party: Arrowhead Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02738008     History of Changes
Other Study ID Numbers: Heparc-2007  2014-004201-33 
Study First Received: April 11, 2016
Last Updated: April 11, 2016
Health Authority: Hong Kong: Department of Health
South Korea: Korea Food and Drug Administration (KFDA)
Germany: Federal Institute for Drugs and Medical Devices
Individual Participant Data  
Plan to Share IPD: No

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

ClinicalTrials.gov processed this record on July 21, 2016