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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
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.


Participant Flow:   Overall Study
    ARC-520   Placebo
STARTED   2   2 
COMPLETED   1   1 
NOT COMPLETED   1   1 



  Baseline Characteristics
  Hide Baseline Characteristics

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
  Hide All Outcome Measures

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

Measure Type Primary
Measure Title Change From Baseline in Quantitative Hepatitis B Surface Antigen (Log qHBsAg) at Day 85
Measure Description No text entered.
Time Frame Baseline, Day 85  

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.
At the time of study termination only 2 ARC-520-treated and 2 placebo-treated participants had been enrolled. Due to the small sample size, analysis of this primary endpoint was not performed.

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.


Measured Values
   ARC-520   Placebo 
Participants Analyzed 
[Units: Participants]
 0   0 
Change From Baseline in Quantitative Hepatitis B Surface Antigen (Log qHBsAg) at Day 85       

No statistical analysis provided for Change From Baseline in Quantitative Hepatitis B Surface Antigen (Log qHBsAg) at 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 ]

Measure Type Secondary
Measure Title Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to Adverse Events (AEs)
Measure Description An AE was defined as any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with treatment. An SAE was defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of an existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; or is a medically important event or reaction. An AE was classified as a TEAE if the AE was not present prior to the first study medication administration and started at or after the time of initiation of administration of study medication, or if the AE presented prior to initiation of administration of study medication, continued and increased in intensity after administration of study medication.
Time Frame From time of informed consent through Day 147 ± 3 days  

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.
All participants who received at least 1 dose of ARC-520 or placebo

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.


Measured Values
   ARC-520   Placebo 
Participants Analyzed 
[Units: Participants]
 2   2 
Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to Adverse Events (AEs) 
[Units: Participants]
   
TEAEs   0   1 
SAEs   0   0 
Deaths   0   0 
Discontinuations due to AEs   0   0 

No statistical analysis provided for Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to Adverse Events (AEs)



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 ]

Measure Type Secondary
Measure Title Pharmacokinetics of ARC-520: Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24)
Measure Description No text entered.
Time Frame Through 48 hours post-dosing on Days 1 and 57  

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.
Pharmacokinetic evaluation was to be performed only on participants receiving ARC-520. At the time of study termination only 2 ARC-520-treated participants had been enrolled and therefore pharmacokinetic samples were not processed and no statistical analysis was performed.

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.


Measured Values
   ARC-520   Placebo 
Participants Analyzed 
[Units: Participants]
 0   0 
Pharmacokinetics of ARC-520: Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24)       

No statistical analysis provided for Pharmacokinetics of ARC-520: Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24)



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 ]

Measure Type Secondary
Measure Title Pharmacokinetics of ARC-520: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Quantifiable Plasma Concentration (AUClast)
Measure Description No text entered.
Time Frame Through 48 hours post-dosing on Days 1 and 57  

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.
Pharmacokinetic evaluation was to be performed only on participants receiving ARC-520. At the time of study termination only 2 ARC-520-treated participants had been enrolled and therefore pharmacokinetic samples were not processed and no statistical analysis was performed.

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.


Measured Values
   ARC-520   Placebo 
Participants Analyzed 
[Units: Participants]
 0   0 
Pharmacokinetics of ARC-520: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Quantifiable Plasma Concentration (AUClast)       

No statistical analysis provided for Pharmacokinetics of ARC-520: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Quantifiable Plasma Concentration (AUClast)



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 ]

Measure Type Secondary
Measure Title Pharmacokinetics of ARC-520: Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUCinf)
Measure Description No text entered.
Time Frame Through 48 hours post-dosing on Days 1 and 57  

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.
Pharmacokinetic evaluation was to be performed only on participants receiving ARC-520. At the time of study termination only 2 ARC-520 treated participants had been enrolled and therefore pharmacokinetic samples were not processed and no statistical analysis was performed.

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.


Measured Values
   ARC-520   Placebo 
Participants Analyzed 
[Units: Participants]
 0   0 
Pharmacokinetics of ARC-520: Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUCinf)       

No statistical analysis provided for Pharmacokinetics of ARC-520: Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUCinf)



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

Measure Type Secondary
Measure Title Pharmacokinetics of ARC-520: Maximum Observed Plasma Concentration (Cmax)
Measure Description No text entered.
Time Frame Through 48 hours post-dosing on Days 1 and 57  

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.
Pharmacokinetic evaluation was to be performed only on participants receiving ARC-520. At the time of study termination only 2 ARC-520 treated participants had been enrolled and therefore pharmacokinetic samples were not processed and no statistical analysis was performed.

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.


Measured Values
   ARC-520   Placebo 
Participants Analyzed 
[Units: Participants]
 0   0 
Pharmacokinetics of ARC-520: Maximum Observed Plasma Concentration (Cmax)       

No statistical analysis provided for Pharmacokinetics of ARC-520: Maximum Observed Plasma Concentration (Cmax)



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

Measure Type Secondary
Measure Title Pharmacokinetics of ARC-520: Apparent Clearance (CL)
Measure Description No text entered.
Time Frame Through 48 hours post-dosing on Days 1 and 57  

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.
Pharmacokinetic evaluation was to be performed only on participants receiving ARC-520. At the time of study termination only 2 ARC-520 treated participants had been enrolled and therefore pharmacokinetic samples were not processed and no statistical analysis was performed.

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.


Measured Values
   ARC-520   Placebo 
Participants Analyzed 
[Units: Participants]
 0   0 
Pharmacokinetics of ARC-520: Apparent Clearance (CL)       

No statistical analysis provided for Pharmacokinetics of ARC-520: Apparent Clearance (CL)



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

Measure Type Secondary
Measure Title Pharmacokinetics of ARC-520: Apparent Volume of Distribution (V)
Measure Description No text entered.
Time Frame Through 48 hours post-dosing on Days 1 and 57  

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.
Pharmacokinetic evaluation was to be performed only on participants receiving ARC-520. At the time of study termination only 2 ARC-520 treated participants had been enrolled and therefore pharmacokinetic samples were not processed and no statistical analysis was performed.

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.


Measured Values
   ARC-520   Placebo 
Participants Analyzed 
[Units: Participants]
 0   0 
Pharmacokinetics of ARC-520: Apparent Volume of Distribution (V)       

No statistical analysis provided for Pharmacokinetics of ARC-520: Apparent Volume of Distribution (V)



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

Measure Type Secondary
Measure Title Pharmacokinetics of ARC-520: Terminal Elimination Rate Constant (Kel)
Measure Description No text entered.
Time Frame Through 48 hours post-dosing on Days 1 and 57  

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.
Pharmacokinetic evaluation was to be performed only on participants receiving ARC-520. At the time of study termination only 2 ARC-520 treated participants had been enrolled and therefore pharmacokinetic samples were not processed and no statistical analysis was performed.

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.


Measured Values
   ARC-520   Placebo 
Participants Analyzed 
[Units: Participants]
 0   0 
Pharmacokinetics of ARC-520: Terminal Elimination Rate Constant (Kel)       

No statistical analysis provided for Pharmacokinetics of ARC-520: Terminal Elimination Rate Constant (Kel)



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

Measure Type Secondary
Measure Title Pharmacokinetics of ARC-520: Terminal Elimination Half-Life (t1/2)
Measure Description No text entered.
Time Frame Through 48 hours post-dosing on Days 1 and 57  

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.
Pharmacokinetic evaluation was to be performed only on participants receiving ARC-520. At the time of study termination only 2 ARC-520 treated participants had been enrolled and therefore pharmacokinetic samples were not processed and no statistical analysis was performed.

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.


Measured Values
   ARC-520   Placebo 
Participants Analyzed 
[Units: Participants]
 0   0 
Pharmacokinetics of ARC-520: Terminal Elimination Half-Life (t1/2)       

No statistical analysis provided for Pharmacokinetics of ARC-520: Terminal Elimination Half-Life (t1/2)



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

Measure Type Secondary
Measure Title Pharmacokinetics of Entecavir or Tenofovir: AUC0-24
Measure Description No text entered.
Time Frame Through 24 hours post-dosing on Days 1 and 57  

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.
Pharmacokinetic evaluation was to be performed only on participants receiving ARC-520. At the time of study termination only 2 ARC-520 treated participants had been enrolled and therefore pharmacokinetic samples were not processed and no statistical analysis was performed.

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.


Measured Values
   ARC-520   Placebo 
Participants Analyzed 
[Units: Participants]
 0   0 
Pharmacokinetics of Entecavir or Tenofovir: AUC0-24       

No statistical analysis provided for Pharmacokinetics of Entecavir or Tenofovir: AUC0-24



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

Measure Type Secondary
Measure Title Pharmacokinetics of Entecavir or Tenofovir: AUClast
Measure Description No text entered.
Time Frame Through 24 hours post-dosing on Days 1 and 57  

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.
Pharmacokinetic evaluation was to be performed only on participants receiving ARC-520. At the time of study termination only 2 ARC-520 treated participants had been enrolled and therefore pharmacokinetic samples were not processed and no statistical analysis was performed.

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.


Measured Values
   ARC-520   Placebo 
Participants Analyzed 
[Units: Participants]
 0   0 
Pharmacokinetics of Entecavir or Tenofovir: AUClast       

No statistical analysis provided for Pharmacokinetics of Entecavir or Tenofovir: AUClast



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

Measure Type Secondary
Measure Title Pharmacokinetics of Entecavir or Tenofovir: Cmax
Measure Description No text entered.
Time Frame Through 24 hours post-dosing on Days 1 and 57  

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.
Pharmacokinetic evaluation was to be performed only on subjects receiving ARC-520. At the time of study termination only 2 ARC-520 treated subjects had been enrolled and therefore pharmacokinetic samples were not processed and no statistical analysis was performed.

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.


Measured Values
   ARC-520   Placebo 
Participants Analyzed 
[Units: Participants]
 0   0 
Pharmacokinetics of Entecavir or Tenofovir: Cmax       

No statistical analysis provided for Pharmacokinetics of Entecavir or Tenofovir: Cmax



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

Measure Type Secondary
Measure Title Pharmacokinetics of Entecavir or Tenofovir: Time of Cmax (Tmax)
Measure Description No text entered.
Time Frame Through 24 hours post-dosing on Days 1 and 57  

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.
Pharmacokinetic evaluation was to be performed only on participants receiving ARC-520. At the time of study termination only 2 ARC-520 treated participants had been enrolled and therefore pharmacokinetic samples were not processed and no statistical analysis was performed.

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.


Measured Values
   ARC-520   Placebo 
Participants Analyzed 
[Units: Participants]
 0   0 
Pharmacokinetics of Entecavir or Tenofovir: Time of Cmax (Tmax)       

No statistical analysis provided for Pharmacokinetics of Entecavir or Tenofovir: Time of Cmax (Tmax)




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
No text entered.


  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