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Study of ARC-520 in Participants With Hepatitis B Virus e Antigen (HBeAg) Positive Chronic Hepatitis B Virus

This study has been terminated.
(Company decision to discontinue trial)
Sponsor:
ClinicalTrials.gov Identifier:
NCT02452528
First Posted: May 22, 2015
Last Update Posted: November 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Arrowhead Pharmaceuticals
Results First Submitted: October 5, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Chronic Hepatitis B
Interventions: Drug: ARC-520
Drug: Placebo
Drug: Entecavir
Drug: Tenofovir
Drug: diphenhydramine

  Participant Flow


  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
ARC-520

Intravenous administration of 1.0 mg/kg ARC-520 once every 4 weeks for 3 total doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day), taken throughout the study.

Pretreatment with diphenhydramine 50 mg 2 hours (±30 minutes) prior to administration of study drug.

Placebo

Intravenous administration of normal saline (0.9%) once every 4 weeks for 3 total doses, plus entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day), taken throughout the study.

Pretreatment with diphenhydramine 50 mg 2 hours (±30 minutes) prior to administration of placebo.

Total Total of all reporting groups

Baseline Measures
   ARC-520   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 2   2   4 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      2 100.0%      2 100.0%      4 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      0   0.0%      1  50.0%      1  25.0% 
Male      2 100.0%      1  50.0%      3  75.0% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
     
Hispanic or Latino      0   0.0%      0   0.0%      0   0.0% 
Not Hispanic or Latino      2 100.0%      2 100.0%      4 100.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      1  50.0%      1  50.0%      2  50.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      1  50.0%      0   0.0%      1  25.0% 
White      0   0.0%      1  50.0%      1  25.0% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   2   2   4 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Quantitative Hepatitis B Surface Antigen (Log qHBsAg) at Day 85   [ Time Frame: Baseline, Day 85 ]

2.  Secondary:   Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to Adverse Events (AEs)   [ Time Frame: From time of informed consent through Day 147 ± 3 days ]

3.  Secondary:   Pharmacokinetics of ARC-520: Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24)   [ Time Frame: Through 48 hours post-dosing on Days 1 and 57 ]

4.  Secondary:   Pharmacokinetics of ARC-520: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Quantifiable Plasma Concentration (AUClast)   [ Time Frame: Through 48 hours post-dosing on Days 1 and 57 ]

5.  Secondary:   Pharmacokinetics of ARC-520: Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUCinf)   [ Time Frame: Through 48 hours post-dosing on Days 1 and 57 ]

6.  Secondary:   Pharmacokinetics of ARC-520: Maximum Observed Plasma Concentration (Cmax)   [ Time Frame: Through 48 hours post-dosing on Days 1 and 57 ]

7.  Secondary:   Pharmacokinetics of ARC-520: Apparent Clearance (CL)   [ Time Frame: Through 48 hours post-dosing on Days 1 and 57 ]

8.  Secondary:   Pharmacokinetics of ARC-520: Apparent Volume of Distribution (V)   [ Time Frame: Through 48 hours post-dosing on Days 1 and 57 ]

9.  Secondary:   Pharmacokinetics of ARC-520: Terminal Elimination Rate Constant (Kel)   [ Time Frame: Through 48 hours post-dosing on Days 1 and 57 ]

10.  Secondary:   Pharmacokinetics of ARC-520: Terminal Elimination Half-Life (t1/2)   [ Time Frame: Through 48 hours post-dosing on Days 1 and 57 ]

11.  Secondary:   Pharmacokinetics of Entecavir or Tenofovir: AUC0-24   [ Time Frame: Through 24 hours post-dosing on Days 1 and 57 ]

12.  Secondary:   Pharmacokinetics of Entecavir or Tenofovir: AUClast   [ Time Frame: Through 24 hours post-dosing on Days 1 and 57 ]

13.  Secondary:   Pharmacokinetics of Entecavir or Tenofovir: Cmax   [ Time Frame: Through 24 hours post-dosing on Days 1 and 57 ]

14.  Secondary:   Pharmacokinetics of Entecavir or Tenofovir: Time of Cmax (Tmax)   [ Time Frame: Through 24 hours post-dosing on Days 1 and 57 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Chief Operating Officer
Organization: Arrowhead Pharmaceuticals, Inc.
phone: 626-304-3400



Responsible Party: Arrowhead Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02452528     History of Changes
Other Study ID Numbers: Heparc-2004
First Submitted: May 15, 2015
First Posted: May 22, 2015
Results First Submitted: October 5, 2017
Results First Posted: November 1, 2017
Last Update Posted: November 1, 2017