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

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ClinicalTrials.gov Identifier: NCT02452528
Recruitment Status : Terminated (Company decision to discontinue trial)
First Posted : May 22, 2015
Results First Posted : November 1, 2017
Last Update Posted : December 5, 2017
Sponsor:
Information provided by (Responsible Party):
Arrowhead Pharmaceuticals

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
Enrollment 4
Recruitment Details  
Pre-assignment Details  
Arm/Group Title ARC-520 Placebo
Hide Arm/Group Description

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.

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.

Period Title: Overall Study
Started 2 2
Completed 1 1
Not Completed 1 1
Arm/Group Title ARC-520 Placebo Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 2 2 4
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 2 participants 4 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  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 2 participants 4 participants
Female
0
   0.0%
1
  50.0%
1
  25.0%
Male
2
 100.0%
1
  50.0%
3
  75.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 2 participants 4 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)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 2 participants 4 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  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 2 participants 2 participants 4 participants
2
 100.0%
2
 100.0%
4
 100.0%
1.Primary Outcome
Title Change From Baseline in Quantitative Hepatitis B Surface Antigen (Log qHBsAg) at Day 85
Hide Description [Not Specified]
Time Frame Baseline, Day 85
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title ARC-520 Placebo
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Deaths, and Discontinuations Due to Adverse Events (AEs)
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All participants who received at least 1 dose of ARC-520 or placebo
Arm/Group Title ARC-520 Placebo
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 2 2
Measure Type: Count of Participants
Unit of Measure: Participants
TEAEs
0
   0.0%
1
  50.0%
SAEs
0
   0.0%
0
   0.0%
Deaths
0
   0.0%
0
   0.0%
Discontinuations due to AEs
0
   0.0%
0
   0.0%
3.Secondary Outcome
Title Pharmacokinetics of ARC-520: Area Under the Plasma Concentration-Time Curve From Time 0 to 24 Hours (AUC0-24)
Hide Description [Not Specified]
Time Frame Through 48 hours post-dosing on Days 1 and 57
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title ARC-520 Placebo
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Pharmacokinetics of ARC-520: Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Quantifiable Plasma Concentration (AUClast)
Hide Description [Not Specified]
Time Frame Through 48 hours post-dosing on Days 1 and 57
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title ARC-520 Placebo
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Pharmacokinetics of ARC-520: Area Under the Plasma Concentration-Time Curve From Time 0 Extrapolated to Infinity (AUCinf)
Hide Description [Not Specified]
Time Frame Through 48 hours post-dosing on Days 1 and 57
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title ARC-520 Placebo
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Pharmacokinetics of ARC-520: Maximum Observed Plasma Concentration (Cmax)
Hide Description [Not Specified]
Time Frame Through 48 hours post-dosing on Days 1 and 57
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title ARC-520 Placebo
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
7.Secondary Outcome
Title Pharmacokinetics of ARC-520: Apparent Clearance (CL)
Hide Description [Not Specified]
Time Frame Through 48 hours post-dosing on Days 1 and 57
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title ARC-520 Placebo
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
8.Secondary Outcome
Title Pharmacokinetics of ARC-520: Apparent Volume of Distribution (V)
Hide Description [Not Specified]
Time Frame Through 48 hours post-dosing on Days 1 and 57
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title ARC-520 Placebo
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
9.Secondary Outcome
Title Pharmacokinetics of ARC-520: Terminal Elimination Rate Constant (Kel)
Hide Description [Not Specified]
Time Frame Through 48 hours post-dosing on Days 1 and 57
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title ARC-520 Placebo
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
10.Secondary Outcome
Title Pharmacokinetics of ARC-520: Terminal Elimination Half-Life (t1/2)
Hide Description [Not Specified]
Time Frame Through 48 hours post-dosing on Days 1 and 57
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title ARC-520 Placebo
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
11.Secondary Outcome
Title Pharmacokinetics of Entecavir or Tenofovir: AUC0-24
Hide Description [Not Specified]
Time Frame Through 24 hours post-dosing on Days 1 and 57
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title ARC-520 Placebo
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
12.Secondary Outcome
Title Pharmacokinetics of Entecavir or Tenofovir: AUClast
Hide Description [Not Specified]
Time Frame Through 24 hours post-dosing on Days 1 and 57
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title ARC-520 Placebo
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
13.Secondary Outcome
Title Pharmacokinetics of Entecavir or Tenofovir: Cmax
Hide Description [Not Specified]
Time Frame Through 24 hours post-dosing on Days 1 and 57
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title ARC-520 Placebo
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
14.Secondary Outcome
Title Pharmacokinetics of Entecavir or Tenofovir: Time of Cmax (Tmax)
Hide Description [Not Specified]
Time Frame Through 24 hours post-dosing on Days 1 and 57
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title ARC-520 Placebo
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame From time of informed consent through Day 147 ± 3 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ARC-520 Placebo
Hide Arm/Group Description

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.

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.

All-Cause Mortality
ARC-520 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)      0/2 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
ARC-520 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/2 (0.00%)      0/2 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
ARC-520 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/2 (0.00%)      1/2 (50.00%)    
General disorders     
Fatigue  1  0/2 (0.00%)  0 1/2 (50.00%)  1
1
Term from vocabulary, MedDRA (17.0)
Indicates events were collected by systematic assessment
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: December 5, 2017