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ENVISION: A Study to Evaluate the Efficacy and Safety of Givosiran (ALN-AS1) in Patients With Acute Hepatic Porphyrias (AHP)

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.
 
ClinicalTrials.gov Identifier: NCT03338816
Recruitment Status : Active, not recruiting
First Posted : November 9, 2017
Results First Posted : February 11, 2020
Last Update Posted : November 16, 2020
Sponsor:
Information provided by (Responsible Party):
Alnylam Pharmaceuticals

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Acute Hepatic Porphyria
Acute Intermittent Porphyria
Porphyria, Acute Intermittent
Acute Porphyria
Hereditary Coproporphyria (HCP)
Variegate Porphyria (VP)
ALA Dehydratase Deficient Porphyria (ADP)
Interventions Drug: Givosiran
Drug: Placebo
Enrollment 94
Recruitment Details Participants with acute hepatic porphyrias (AHP) were enrolled at thirty-six sites in Australia, Bulgaria, Canada, Germany, Denmark, Spain, Finland, France, United Kingdom, Italy, Japan, Korea (the Republic of), Mexico, Netherlands, Poland, Sweden, Taiwan and the United States.
Pre-assignment Details  
Arm/Group Title Placebo/Givosiran Givosiran/Givosiran
Hide Arm/Group Description Matching placebo (normal saline [0.9% NaCl]) was administered subcutaneously (SC), monthly (QM), for 6 months during the 6-Month Double-blind (DB) Period, followed by givosiran 2.5 mg/kg or 1.25 mg/kg SC, QM for 29 months during the Open-label Extension (OLE) period. Givosiran 2.5 mg/kg administered SC, QM, for 6 months during the 6-Month DB Period, followed by givosiran 2.5 mg/kg or 1.25 mg/kg SC, QM mg/kg for 29 months during the OLE Period.
Period Title: 6-Month Double-blind Period
Started 46 48
Completed 46 47 [1]
Not Completed 0 1
Reason Not Completed
Adverse Event             0             1
[1]
1 participant discontinued treatment during the 6-month DB period but completed the 6-month DB Visit
Period Title: Open-Label Extension Period
Started 46 47
Completed 0 0
Not Completed 46 47
Reason Not Completed
Ongoing in Study             46             47
Arm/Group Title Placebo/Givosiran Givosiran/Givosiran Total
Hide Arm/Group Description Matching placebo (normal saline [0.9% NaCl]) was administered SC, QM, for 6 months during the 6-Month DB Period, followed by givosiran 2.5 mg/kg or 1.25 mg/kg SC, QM for 29 months during the OLE period. Givosiran 2.5 mg/kg administered SC, QM, for 6 months during the 6-Month DB Period, followed by givosiran 2.5 mg/kg or 1.25 mg/kg SC, QM for 29 months during the OLE Period. Total of all reporting groups
Overall Number of Baseline Participants 46 48 94
Hide Baseline Analysis Population Description
Safety Analysis Set (SAS) consisted of all participants who received at least one dose of study drug.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 46 participants 48 participants 94 participants
37.4  (10.5) 40.1  (12.1) 38.8  (11.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 48 participants 94 participants
Female
41
  89.1%
43
  89.6%
84
  89.4%
Male
5
  10.9%
5
  10.4%
10
  10.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 48 participants 94 participants
Hispanic or Latino
3
   6.5%
5
  10.4%
8
   8.5%
Not Hispanic or Latino
42
  91.3%
42
  87.5%
84
  89.4%
Unknown or Not Reported
1
   2.2%
1
   2.1%
2
   2.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 46 participants 48 participants 94 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
7
  15.2%
8
  16.7%
15
  16.0%
Native Hawaiian or Other Pacific Islander
1
   2.2%
0
   0.0%
1
   1.1%
Black or African American
1
   2.2%
0
   0.0%
1
   1.1%
White
34
  73.9%
39
  81.3%
73
  77.7%
More than one race
1
   2.2%
0
   0.0%
1
   1.1%
Unknown or Not Reported
2
   4.3%
1
   2.1%
3
   3.2%
1.Primary Outcome
Title Annualized Rate of Porphyria Attacks in Participants With Acute Intermittent Porphyria (AIP)
Hide Description Porphyria attacks were defined as meeting all of the following criteria: an acute episode of neurovisceral pain in the abdomen, back, chest, extremities and/or limbs, no other medically determined cause, and required treatment with intravenous (IV) dextrose or hemin, carbohydrates, or analgesics, or other medications such as antiemetics at a dose or frequency beyond the participant's usual daily porphyria management. The annualized rate of porphyria attacks is a composite endpoint which included porphyria attacks requiring hospitalization, urgent healthcare visit, or IV hemin administration at home.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
AIP participants in the Full Analysis Set (FASAIP): All randomized AIP participants (with identified mutation in the hydroxymethylbilane synthase [HMBS] gene) who received at least one dose of study drug.
Arm/Group Title Placebo Givosiran 2.5 mg/kg
Hide Arm/Group Description:
Matching placebo (normal saline [0.9% NaCl]) was administered SC, QM, for 6 months during the 6-Month DB Period.
Givosiran 2.5 mg/kg administered SC, QM, for 6 months during the 6-Month DB Period.
Overall Number of Participants Analyzed 43 46
Mean (95% Confidence Interval)
Unit of Measure: annualized attack rate
12.52
(9.35 to 16.76)
3.22
(2.25 to 4.59)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Givosiran 2.5 mg/kg
Comments Negative binomial regression model with treatment group and stratification factors (prior hemin prophylaxis status and historical attack rates) as fixed effects and the logarithm of the follow-up time as an offset variable.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P=6.040E-09
Method Negative binomial regression model
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate ratio
Estimated Value 0.26
Confidence Interval (2-Sided) 95%
0.16 to 0.41
Estimation Comments [Not Specified]
2.Secondary Outcome
Title The Pharmacodynamic (PD) Effect of Givosiran on Urine Levels of Delta-aminolevulinic Acid (ALA) in Participants With AIP
Hide Description The PD effect of givosiran was evaluated by spot urine ALA levels normalized to spot urine creatinine levels.
Time Frame 3 and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
FASAIP: All randomized AIP participants (with identified mutation in the HMBS gene) who received at least one dose of study drug.
Arm/Group Title Placebo Givosiran 2.5 mg/kg
Hide Arm/Group Description:
Matching placebo (normal saline [0.9% NaCl]) was administered SC, QM, for 6 months during the 6-Month DB Period.
Givosiran 2.5 mg/kg administered SC, QM, for 6 months during the 6-Month DB Period.
Overall Number of Participants Analyzed 43 46
Least Squares Mean (Standard Error)
Unit of Measure: mmol/mol creatinine (Cr)
Month 3 19.965  (1.475) 1.756  (1.413)
Month 6 23.150  (2.534) 4.013  (2.352)
3.Secondary Outcome
Title The PD Effect of Givosiran on Urine Levels of Porphobilinogen (PBG) in Participants With AIP
Hide Description The PD effect of givosiran was evaluated by spot urine PBG levels normalized to spot urine creatinine levels.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
FASAIP: All randomized AIP participants (with identified mutation in the HMBS gene) who received at least one dose of study drug.
Arm/Group Title Placebo Givosiran 2.5 mg/kg
Hide Arm/Group Description:
Matching placebo (normal saline [0.9% NaCl]) was administered SC, QM, for 6 months during the 6-Month DB Period.
Givosiran 2.5 mg/kg administered SC, QM, for 6 months during the 6-Month DB Period.
Overall Number of Participants Analyzed 43 46
Least Squares Mean (Standard Error)
Unit of Measure: mmol/mol Cr
49.110  (4.959) 12.906  (4.642)
4.Secondary Outcome
Title Annualized Rate of Hemin Administration in Participants With AIP
Hide Description Annualized rate of hemin doses was evaluated as annualized days of hemin use.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
FASAIP: All randomized AIP participants (with identified mutation in the HMBS gene) who received at least one dose of study drug.
Arm/Group Title Placebo Givosiran 2.5 mg/kg
Hide Arm/Group Description:
Matching placebo (normal saline [0.9% NaCl]) was administered SC, QM, for 6 months during the 6-Month DB Period.
Givosiran 2.5 mg/kg administered SC, QM, for 6 months during the 6-Month DB Period.
Overall Number of Participants Analyzed 43 46
Mean (95% Confidence Interval)
Unit of Measure: annualized rate of use
29.71
(18.41 to 47.94)
6.77
(4.20 to 10.92)
5.Secondary Outcome
Title Annualized Rate of Porphyria Attacks in Participants With AHP
Hide Description Porphyria attacks were defined as meeting all of the following criteria: an acute episode of neurovisceral pain in the abdomen, back, chest, extremities and/or limbs, no other medically determined cause, and required treatment with intravenous (IV) dextrose or hemin, carbohydrates, or analgesics, or other medications such as antiemetics at a dose or frequency beyond the participant's usual daily porphyria management. The annualized rate of porphyria attacks is a composite endpoint which included porphyria attacks requiring hospitalization, urgent healthcare visit, or IV hemin administration at home.
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS): All randomized patients who received at least one dose of study drug.
Arm/Group Title Placebo Givosiran 2.5 mg/kg
Hide Arm/Group Description:
Matching placebo (normal saline [0.9% NaCl]) was administered SC, QM, for 6 months during the 6-Month DB Period.
Givosiran 2.5 mg/kg administered SC, QM, for 6 months during the 6-Month DB Period.
Overall Number of Participants Analyzed 46 48
Mean (95% Confidence Interval)
Unit of Measure: annualized attack rate
12.26
(9.22 to 16.29)
3.35
(2.37 to 4.74)
6.Secondary Outcome
Title Area Under the Curve (AUC) of the Change From Baseline in Weekly Mean Score of Daily Worst Pain as Measured by the Brief Pain Inventory-Short Form (BPI-SF) Numeric Rating Scale (NRS) in Participants With AIP
Hide Description Participants rated worst daily pain score in an eDiary using the 11-point BPI-SF NRS, in which 0=no pain and 10=worst pain. Daily eDiary entries were averaged into a weekly (i.e. 7 day) score. The change from baseline in weekly mean scores is defined as the post baseline weekly mean score minus the baseline score. Lower scores indicate an improvement. The 6-month AUC was calculated based on change from baseline in weekly mean scores.
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
FASAIP: All randomized AIP participants (with identified mutation in the HMBS gene) who received at least one dose of study drug.
Arm/Group Title Placebo Givosiran 2.5 mg/kg
Hide Arm/Group Description:
Matching placebo (normal saline [0.9% NaCl]) was administered SC, QM, for 6 months during the 6-Month DB Period.
Givosiran 2.5 mg/kg administered SC, QM, for 6 months during the 6-Month DB Period.
Overall Number of Participants Analyzed 43 46
Median (Inter-Quartile Range)
Unit of Measure: score on a scale*week
5.286
(-23.048 to 11.145)
-11.514
(-29.181 to 3.040)
7.Secondary Outcome
Title Average Change From Baseline in Weekly Mean Score of Daily Worst Pain as Measured by the Brief Pain Inventory-Short Form (BPI-SF) Numeric Rating Scale (NRS) in Participants With AIP
Hide Description Participants rated worst daily pain score in an eDiary using the 11-point BPI-SF NRS, in which 0=no pain and 10=worst pain. Daily eDiary entries were averaged into a weekly (i.e. 7 day) score. The change from baseline in weekly mean scores is defined as the postbaseline weekly mean score minus the baseline score. Lower scores indicate an improvement.
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
FASAIP: All randomized AIP participants (with identified mutation in the HMBS gene) who received at least one dose of study drug.
Arm/Group Title Placebo Givosiran 2.5 mg/kg
Hide Arm/Group Description:
Matching placebo (normal saline [0.9% NaCl]) was administered SC, QM, for 6 months during the 6-Month DB Period.
Givosiran 2.5 mg/kg administered SC, QM, for 6 months during the 6-Month DB Period.
Overall Number of Participants Analyzed 43 46
Median (Inter-Quartile Range)
Unit of Measure: score on a scale
0.245
(-1.020 to 0.470)
-0.506
(-1.309 to 0.143)
8.Secondary Outcome
Title AUC of the Change From Baseline in Weekly Mean Score of Daily Worst Fatigue Score as Measured by the Brief Fatigue Inventory-Short Form (BFI-SF) NRS in Participants With AIP
Hide Description Participants rated daily worst fatigue score in an eDiary using the 11-point BFI-SF NRS, in which 0=no fatigue and 10=worst fatigue. Daily eDiary entries were averaged into a weekly (i.e. 7 day) score. The change from baseline in weekly mean scores is defined as the post baseline weekly mean score minus the baseline score. Lower scores indicate an improvement. The 6-month AUC was calculated based on change from baseline in weekly mean scores.
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
FASAIP: All randomized AIP participants (with identified mutation in the HMBS gene) who received at least one dose of study drug.
Arm/Group Title Placebo Givosiran 2.5 mg/kg
Hide Arm/Group Description:
Matching placebo (normal saline [0.9% NaCl]) was administered SC, QM, for 6 months during the 6-Month DB Period.
Givosiran 2.5 mg/kg administered SC, QM, for 6 months during the 6-Month DB Period.
Overall Number of Participants Analyzed 43 46
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale*week
-4.208  (4.689) -11.148  (4.501)
9.Secondary Outcome
Title Average Change From Baseline in Weekly Mean Score of Daily Worst Fatigue Score as Measured by the Brief Fatigue Inventory-Short Form (BFI-SF) NRS in Participants With AIP
Hide Description Participants rated daily worst fatigue score in an eDiary using the 11-point BFI-SF NRS, in which 0=no fatigue and 10=worst fatigue. Daily eDiary entries were averaged into a weekly (i.e. 7 day) score. The change from baseline in weekly mean scores is defined as the postbaseline weekly mean score minus the baseline score. Lower scores indicate an improvement.
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
FASAIP: All randomized AIP participants (with identified mutation in the HMBS gene) who received at least one dose of study drug.
Arm/Group Title Placebo Givosiran 2.5 mg/kg
Hide Arm/Group Description:
Matching placebo (normal saline [0.9% NaCl]) was administered SC, QM, for 6 months during the 6-Month DB Period.
Givosiran 2.5 mg/kg administered SC, QM, for 6 months during the 6-Month DB Period.
Overall Number of Participants Analyzed 43 46
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-0.182  (0.209) -0.502  (0.200)
10.Secondary Outcome
Title AUC of the Change From Baseline in Weekly Mean Score Daily Worst Nausea Score as Measured by NRS in Participants With AIP
Hide Description Participants rated worst daily nausea score in an eDiary using an 11-point NRS, in which 0=no nausea and 10=worst nausea. Daily eDiary entries were averaged into a weekly (i.e. 7 day) score. The change from baseline in weekly mean scores is defined as the postbaseline weekly mean score minus the baseline score. Lower scores indicate an improvement. The 6-month AUC was calculated based on change from baseline in weekly mean scores.
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
FASAIP: All randomized AIP participants (with identified mutation in the HMBS gene) who received at least one dose of study drug.
Arm/Group Title Placebo Givosiran 2.5 mg/kg
Hide Arm/Group Description:
Matching placebo (normal saline [0.9% NaCl]) was administered SC, QM, for 6 months during the 6-Month DB Period.
Givosiran 2.5 mg/kg administered SC, QM, for 6 months during the 6-Month DB Period.
Overall Number of Participants Analyzed 43 46
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-4.011  (3.453) 1.481  (3.310)
11.Secondary Outcome
Title Average Change From Baseline in Weekly Mean Score Daily Worst Nausea Score as Measured by NRS in Participants With AIP
Hide Description Participants rated worst daily nausea score in an eDiary using an 11-point NRS, in which 0=no nausea and 10=worst nausea. Daily eDiary entries were averaged into a weekly (i.e. 7 day) score. The change from baseline in weekly mean scores is defined as the postbaseline weekly mean score minus the baseline score. Lower scores indicate an improvement.
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
FASAIP: All randomized AIP participants (with identified mutation in the HMBS gene) who received at least one dose of study drug.
Arm/Group Title Placebo Givosiran 2.5 mg/kg
Hide Arm/Group Description:
Matching placebo (normal saline [0.9% NaCl]) was administered SC, QM, for 6 months during the 6-Month DB Period.
Givosiran 2.5 mg/kg administered SC, QM, for 6 months during the 6-Month DB Period.
Overall Number of Participants Analyzed 43 46
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
-0.181  (0.154) 0.067  (0.147)
12.Secondary Outcome
Title Change From Baseline in the Physical Component Summary (PCS) of the 12-Item Short Form Survey (SF-12) in Participants With AIP
Hide Description The SF-12 is a survey designed for use in patients with multiple chronic conditions. This 12-item scale can be used to assess the physical and mental health of respondents. 10 of the 12 questions are answered on a 5 point likert scale and 2 are answered on a 3 point likert scale. The questions are then scored and weighted into 2 subscales, physical health and mental health. Respondents can have a score that ranges from 0-100 with 100 being the best score and indicating high physical or mental health. A 3 point change in SF-12 score reflects a meaningful difference. A higher score indicates improvement.
Time Frame Baseline and 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
FASAIP: All randomized AIP participants (with identified mutation in the HMBS gene) who received at least one dose of study drug.
Arm/Group Title Placebo Givosiran 2.5 mg/kg
Hide Arm/Group Description:
Matching placebo (normal saline [0.9% NaCl]) was administered SC, QM, for 6 months during the 6-Month DB Period.
Givosiran 2.5 mg/kg administered SC, QM, for 6 months during the 6-Month DB Period.
Overall Number of Participants Analyzed 43 46
Least Squares Mean (Standard Error)
Unit of Measure: score on a scale
1.431  (1.220) 5.369  (1.169)
Time Frame From the first dose of study drug through 6-Month Double-blind Period.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Givosiran 2.5 mg/kg
Hide Arm/Group Description Matching placebo (normal saline [0.9% NaCl]) was administered SC, QM, for 6 months during the 6-Month DB Period. Givosiran 2.5 mg/kg administered SC, QM, for 6 months during the 6-Month DB Period.
All-Cause Mortality
Placebo Givosiran 2.5 mg/kg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/46 (0.00%)   0/48 (0.00%) 
Hide Serious Adverse Events
Placebo Givosiran 2.5 mg/kg
Affected / at Risk (%) Affected / at Risk (%)
Total   4/46 (8.70%)   10/48 (20.83%) 
General disorders     
Pyrexia  1  1/46 (2.17%)  1/48 (2.08%) 
Infections and infestations     
Device related infection  1  2/46 (4.35%)  1/48 (2.08%) 
Escherichia urinary tract infection  1  1/46 (2.17%)  0/48 (0.00%) 
Gastroenteritis  1  0/46 (0.00%)  1/48 (2.08%) 
Sepsis  1  1/46 (2.17%)  0/48 (0.00%) 
Septic shock  1  1/46 (2.17%)  0/48 (0.00%) 
Injury, poisoning and procedural complications     
Fractured sacrum  1  1/46 (2.17%)  0/48 (0.00%) 
Investigations     
Liver function test abnormal  1  0/46 (0.00%)  1/48 (2.08%) 
Metabolism and nutrition disorders     
Hypoglycaemia  1  0/46 (0.00%)  1/48 (2.08%) 
Psychiatric disorders     
Major depression  1  0/46 (0.00%)  1/48 (2.08%) 
Renal and urinary disorders     
Chronic kidney disease  1  0/46 (0.00%)  2/48 (4.17%) 
Respiratory, thoracic and mediastinal disorders     
Asthma  1  0/46 (0.00%)  1/48 (2.08%) 
Surgical and medical procedures     
Pain management  1  0/46 (0.00%)  1/48 (2.08%) 
1
Term from vocabulary, MedDRA (21.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Givosiran 2.5 mg/kg
Affected / at Risk (%) Affected / at Risk (%)
Total   37/46 (80.43%)   43/48 (89.58%) 
Gastrointestinal disorders     
Abdominal pain  1  3/46 (6.52%)  4/48 (8.33%) 
Constipation  1  0/46 (0.00%)  3/48 (6.25%) 
Dyspepsia  1  4/46 (8.70%)  0/48 (0.00%) 
Nausea  1  5/46 (10.87%)  13/48 (27.08%) 
Vomiting  1  5/46 (10.87%)  0/48 (0.00%) 
General disorders     
Asthenia  1  4/46 (8.70%)  3/48 (6.25%) 
Fatigue  1  0/46 (0.00%)  5/48 (10.42%) 
Injection site reaction  1  0/46 (0.00%)  8/48 (16.67%) 
Pyrexia  1  5/46 (10.87%)  0/48 (0.00%) 
Infections and infestations     
Nasopharyngitis  1  3/46 (6.52%)  4/48 (8.33%) 
Tooth infection  1  0/46 (0.00%)  3/48 (6.25%) 
Upper respiratory tract infection  1  3/46 (6.52%)  4/48 (8.33%) 
Urinary tract infection  1  6/46 (13.04%)  3/48 (6.25%) 
Investigations     
Alanine aminotransferase increased  1  0/46 (0.00%)  4/48 (8.33%) 
Aspartate aminotransferase increased  1  0/46 (0.00%)  3/48 (6.25%) 
Glomerular filtration rate decreased  1  0/46 (0.00%)  3/48 (6.25%) 
Lipase increased  1  3/46 (6.52%)  0/48 (0.00%) 
Musculoskeletal and connective tissue disorders     
Back pain  1  4/46 (8.70%)  0/48 (0.00%) 
Myalgia  1  3/46 (6.52%)  0/48 (0.00%) 
Nervous system disorders     
Dizziness  1  3/46 (6.52%)  0/48 (0.00%) 
Headache  1  7/46 (15.22%)  6/48 (12.50%) 
Hypoaesthesia  1  4/46 (8.70%)  0/48 (0.00%) 
Product Issues     
Device occlusion  1  0/46 (0.00%)  3/48 (6.25%) 
Psychiatric disorders     
Anxiety  1  3/46 (6.52%)  0/48 (0.00%) 
Renal and urinary disorders     
Chronic kidney disease  1  0/46 (0.00%)  3/48 (6.25%) 
Skin and subcutaneous tissue disorders     
Rash  1  0/46 (0.00%)  3/48 (6.25%) 
1
Term from vocabulary, MedDRA (21.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Alnylam Pharmaceuticals Inc
Phone: 866-330-0326
EMail: Clinicaltrials@alnylam.com
Layout table for additonal information
Responsible Party: Alnylam Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03338816    
Other Study ID Numbers: ALN-AS1-003
First Submitted: November 7, 2017
First Posted: November 9, 2017
Results First Submitted: January 30, 2020
Results First Posted: February 11, 2020
Last Update Posted: November 16, 2020