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Trial of AAV5-hFIX in Severe or Moderately Severe Hemophilia B

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: NCT02396342
Recruitment Status : Completed
First Posted : March 24, 2015
Results First Posted : June 27, 2022
Last Update Posted : June 27, 2022
Sponsor:
Information provided by (Responsible Party):
CSL Behring

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hemophilia B
Intervention Genetic: AAV5-hFIX
Enrollment 10
Recruitment Details  
Pre-assignment Details

Patients with congenital haemophilia B. Known severe FIX deficiency with plasma FIX activity level < 1% and a severe bleeding phenotype.

Known moderately severe FIX deficiency with plasma FIX activity level between ≥ 1% and ≤ 2% and a severe bleeding phenotype.

More than 150 previous exposure days of treatment with FIX protein
Arm/Group Title AAV5-hFIX Low Dose (Cohort 1) AAV5-hFIX High Dose (Cohort 2)
Hide Arm/Group Description

AAV5-hFIX 5 × 10E12 gc/kg intravenous single infusion

AAV5-hFIX: AAV5hFIX gene therapy

AAV5-hFIX 2 × 10E13 gc/kg intravenous single infusion

AAV5-hFIX: AAV5hFIX gene therapy
Period Title: Overall Study
Started 5 5
Completed 5 5
Not Completed 0 0
Arm/Group Title AAV5-hFIX Low Dose (Cohort 1) AAV5-hFIX High Dose (Cohort 2) Total
Hide Arm/Group Description

AAV5-hFIX 5 × 10E12 gc/kg intravenous single infusion

AAV5-hFIX: AAV5hFIX gene therapy

AAV5-hFIX 2 × 10E13 gc/kg intravenous single infusion

AAV5-hFIX: AAV5hFIX gene therapy

 Total of all reporting groups
Overall Number of Baseline Participants 5 5 10
Hide Baseline Analysis Population Description
Full Analysis Set which was comprised of all dosed subjects.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 10 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
2
  40.0%
5
 100.0%
7
  70.0%
>=65 years
3
  60.0%
0
   0.0%
3
  30.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants 5 participants 10 participants
60.2  (15.9) 38.2  (5.9) 49.2  (16.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 10 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
5
 100.0%
5
 100.0%
10
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 10 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
5
 100.0%
5
 100.0%
10
 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 5 participants 5 participants 10 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
1
  20.0%
1
  10.0%
White
5
 100.0%
4
  80.0%
9
  90.0%
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: Number
Unit of measure:  Participants
 Number Analyzed 5 participants 5 participants 10 participants
Netherlands 3 3 6
Denmark 1 0 1
Germany 1 2 3
1.Primary Outcome
Title Number of Participants With Adverse Events
Hide Description [Not Specified]
Time Frame From AMT-060 infusion through end of study (5 years post-dose)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) which was comprised of all dosed subjects
Arm/Group Title AAV5-hFIX Low Dose (Cohort 1) AAV5-hFIX High Dose (Cohort 2)
Hide Arm/Group Description:

AAV5-hFIX 5 × 10E12 gc/kg intravenous single infusion

AAV5-hFIX: AAV5hFIX gene therapy

AAV5-hFIX 2 × 10E13 gc/kg intravenous single infusion

AAV5-hFIX: AAV5hFIX gene therapy
Overall Number of Participants Analyzed 5 5
Measure Type: Number
Unit of Measure: participants
5 5
2.Secondary Outcome
Title FIX-replacement-therapy-free FIX Activity
Hide Description FIX activity measured any time from 72 hours after latest FIX replacement therapy administration and until next administration of FIX replacement therapy. Only assessments performed more than 10 days after most recent FIX-replacement therapy administration included.
Time Frame From AMT-060 infusion through end of study (5 years post-dose)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Only assessments performed more than 10 days after most recent FIX-replacement therapy administration included.
Arm/Group Title AAV5-hFIX Low Dose (Cohort 1) AAV5-hFIX High Dose (Cohort 2)
Hide Arm/Group Description:

AAV5-hFIX 5 × 10E12 gc/kg intravenous single infusion

AAV5-hFIX: AAV5hFIX gene therapy

AAV5-hFIX 2 × 10E13 gc/kg intravenous single infusion

AAV5-hFIX: AAV5hFIX gene therapy
Overall Number of Participants Analyzed 4 5
Mean (Standard Deviation)
Unit of Measure: Percent FIX activity
one-stage aPTT assay Number Analyzed 4 participants 4 participants
7.43  (1.28) 6.60  (1.96)
amidolytic/chromogenic assay Number Analyzed 4 participants 5 participants
4.58  (2.88) 4.74  (1.43)
3.Secondary Outcome
Title Total Annualized Bleeding Rate (ABR)
Hide Description Annualized: Sum of post-treatment bleeding episodes divided by subjects' average number of years (365.25 days) from treatment start to until the data cutoff date.
Time Frame From AMT-060 infusion through end of study (5 years post-dose)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. One subject in Cohort 2 did not report any bleeding information for the period 1 year prior to screening. Post-tapering period = from discontinuation of FIX prophylaxis until data cutoff.
Arm/Group Title AAV5-hFIX Low Dose (Cohort 1) AAV5-hFIX High Dose (Cohort 2)
Hide Arm/Group Description:

AAV5-hFIX 5 × 10E12 gc/kg intravenous single infusion

AAV5-hFIX: AAV5hFIX gene therapy

AAV5-hFIX 2 × 10E13 gc/kg intravenous single infusion

AAV5-hFIX: AAV5hFIX gene therapy
Overall Number of Participants Analyzed 5 5
Mean (Standard Deviation)
Unit of Measure: bleeds/year/subject
One Year Prior to Screening Number Analyzed 5 participants 4 participants
14.40  (5.73) 4.00  (3.16)
Post-tapering Period Number Analyzed 5 participants 5 participants
5.39  (5.94) 0.71  (0.58)
4.Secondary Outcome
Title Total Consumption of FIX Replacement Therapy
Hide Description [Not Specified]
Time Frame From AMT-060 infusion through end of study (5 years post dose).
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Post-tapering period = from discontinuation of FIX prophylaxis until data cutoff.
Arm/Group Title AAV5-hFIX Low Dose (Cohort 1) AAV5-hFIX High Dose (Cohort 2)
Hide Arm/Group Description:

AAV5-hFIX 5 × 10E12 gc/kg intravenous single infusion

AAV5-hFIX: AAV5hFIX gene therapy

AAV5-hFIX 2 × 10E13 gc/kg intravenous single infusion

AAV5-hFIX: AAV5hFIX gene therapy
Overall Number of Participants Analyzed 5 5
Mean (Standard Deviation)
Unit of Measure: IU
One year prior to screening 326532  (234900) 233778  (156873)
Post-tapering period 252950  (222790) 85800  (84482)
5.Secondary Outcome
Title Change From Baseline in Short Form-36 (SF-36) Quality of Life (QoL) Scores
Hide Description Scores range from 0 to 100, with a higher score defining a more favorable health state.
Time Frame From AMT-060 infusion through the end of study (5 years post dose)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title AAV5-hFIX Low Dose (Cohort 1) AAV5-hFIX High Dose (Cohort 2)
Hide Arm/Group Description:

AAV5-hFIX 5 × 10E12 gc/kg intravenous single infusion

AAV5-hFIX: AAV5hFIX gene therapy

AAV5-hFIX 2 × 10E13 gc/kg intravenous single infusion

AAV5-hFIX: AAV5hFIX gene therapy
Overall Number of Participants Analyzed 5 5
Mean (Standard Deviation)
Unit of Measure: score on a scale
Physical Functioning 0.00  (10.00) -7.00  (9.75)
Role-Physical -15.00  (8.39) -10.00  (22.79)
Bodily Pain -9.00  (9.00) 1.20  (14.81)
General Health -0.80  (20.22) -2.40  (8.99)
Vitality -11.25  (19.96) -6.25  (12.50)
Social Functioning -20.00  (25.92) -5.00  (14.25)
Role-Emotional -13.33  (27.39) -10.00  (13.69)
Mental Health -13.00  (22.80) -9.00  (12.94)
6.Secondary Outcome
Title Time to Vector DNA Stopped Shedding From Blood, Nasal Secretions, Saliva, Urine, Feces, and Semen
Hide Description [Not Specified]
Time Frame From AMT-060 infusion through end of study (5 years post dose).
Hide Outcome Measure Data
Hide Analysis Population Description
FAS. Subject in Cohort 1 was unable to produce semen due to a historical medical condition.
Arm/Group Title AAV5-hFIX Low Dose (Cohort 1) AAV5-hFIX High Dose (Cohort 2)
Hide Arm/Group Description:

AAV5-hFIX 5 × 10E12 gc/kg intravenous single infusion

AAV5-hFIX: AAV5hFIX gene therapy

AAV5-hFIX 2 × 10E13 gc/kg intravenous single infusion

AAV5-hFIX: AAV5hFIX gene therapy
Overall Number of Participants Analyzed 5 5
Mean (Standard Deviation)
Unit of Measure: Days
Blood Number Analyzed 5 participants 5 participants
508.8  (261.7) 705.4  (245.1)
Nasal secretions Number Analyzed 5 participants 5 participants
83.4  (41.7) 108.4  (66.0)
Saliva Number Analyzed 5 participants 5 participants
75.8  (38.4) 129.2  (48.9)
Urine Number Analyzed 5 participants 5 participants
46.4  (20.9) 82.0  (41.1)
Feces Number Analyzed 5 participants 5 participants
74.0  (25.7) 165.0  (68.9)
Semen Number Analyzed 4 participants 5 participants
227.8  (147.7) 157.2  (78.4)
7.Secondary Outcome
Title Number of Subjects Developing Neutralizing Antibodies to AAV5
Hide Description [Not Specified]
Time Frame From AMT-060 infusion through end of study (5 years post dose)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title AAV5-hFIX Low Dose (Cohort 1) AAV5-hFIX High Dose (Cohort 2)
Hide Arm/Group Description:

AAV5-hFIX 5 × 10E12 gc/kg intravenous single infusion

AAV5-hFIX: AAV5hFIX gene therapy

AAV5-hFIX 2 × 10E13 gc/kg intravenous single infusion

AAV5-hFIX: AAV5hFIX gene therapy
Overall Number of Participants Analyzed 5 5
Measure Type: Number
Unit of Measure: participants
5 5
8.Secondary Outcome
Title Total IgG and IgM Antibody Titers to AAV5
Hide Description For subjects with a titer of 109350 and 50, the actual titer is >109350 and <50.
Time Frame AMT-060 infusion through end of study (5 years post dose)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title AAV5-hFIX Low Dose (Cohort 1) AAV5-hFIX High Dose (Cohort 2)
Hide Arm/Group Description:

AAV5-hFIX 5 × 10E12 gc/kg intravenous single infusion

AAV5-hFIX: AAV5hFIX gene therapy

AAV5-hFIX 2 × 10E13 gc/kg intravenous single infusion

AAV5-hFIX: AAV5hFIX gene therapy
Overall Number of Participants Analyzed 5 5
Measure Type: Number
Unit of Measure: Titer
IgG (subject 1) 79499 109350
IgG (subject 2) 109350 109350
IgG (subject 3) 109350 109350
IgG (subject 4) 109350 107344
IgG (subject 5) 109350 109350
IgM (subject 1) 56 30071
IgM (subject 2) 1321 20000
IgM (subject 3) 557 6649
IgM (subject 4) 11568 50
IgM (subject 5) 809 50
9.Secondary Outcome
Title Number of Subjects With a Positive AAV5 Capsid-specific T Cell Response
Hide Description Specific AAV5 response (results >17 SFC/million PBMCs) were regarded as positive.
Time Frame From AMT-060 infusion through 26 weeks post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title AAV5-hFIX Low Dose (Cohort 1) AAV5-hFIX High Dose (Cohort 2)
Hide Arm/Group Description:

AAV5-hFIX 5 × 10E12 gc/kg intravenous single infusion

AAV5-hFIX: AAV5hFIX gene therapy

AAV5-hFIX 2 × 10E13 gc/kg intravenous single infusion

AAV5-hFIX: AAV5hFIX gene therapy
Overall Number of Participants Analyzed 5 5
Measure Type: Number
Unit of Measure: participants
1 0
10.Secondary Outcome
Title Number of Subjects With Antibodies to FIX
Hide Description [Not Specified]
Time Frame From AMT-060 infusion through the end of study (5 years post dose)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title AAV5-hFIX Low Dose (Cohort 1) AAV5-hFIX High Dose (Cohort 2)
Hide Arm/Group Description:

AAV5-hFIX 5 × 10E12 gc/kg intravenous single infusion

AAV5-hFIX: AAV5hFIX gene therapy

AAV5-hFIX 2 × 10E13 gc/kg intravenous single infusion

AAV5-hFIX: AAV5hFIX gene therapy
Overall Number of Participants Analyzed 5 5
Measure Type: Number
Unit of Measure: participants
1 0
11.Secondary Outcome
Title Number of Subjects With FIX Inhibitors
Hide Description [Not Specified]
Time Frame From AMT-060 infusion through the end of study (5 years post dose)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title AAV5-hFIX Low Dose (Cohort 1) AAV5-hFIX High Dose (Cohort 2)
Hide Arm/Group Description:

AAV5-hFIX 5 × 10E12 gc/kg intravenous single infusion

AAV5-hFIX: AAV5hFIX gene therapy

AAV5-hFIX 2 × 10E13 gc/kg intravenous single infusion

AAV5-hFIX: AAV5hFIX gene therapy
Overall Number of Participants Analyzed 5 5
Measure Type: Number
Unit of Measure: participants
0 0
12.Secondary Outcome
Title Number of Subjects With Clinically Significant Inflammatory Markers: IL-1β, IL-2, IL-6, INFγ, MCP-1
Hide Description [Not Specified]
Time Frame From AMT-060 infusion through 18 weeks post dose
Hide Outcome Measure Data
Hide Analysis Population Description
FAS
Arm/Group Title AAV5-hFIX Low Dose (Cohort 1) AAV5-hFIX High Dose (Cohort 2)
Hide Arm/Group Description:

AAV5-hFIX 5 × 10E12 gc/kg intravenous single infusion

AAV5-hFIX: AAV5hFIX gene therapy

AAV5-hFIX 2 × 10E13 gc/kg intravenous single infusion

AAV5-hFIX: AAV5hFIX gene therapy
Overall Number of Participants Analyzed 5 5
Measure Type: Number
Unit of Measure: participants
0 0
Time Frame 5 years post-dose
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title AAV5-hFIX Low Dose (Cohort 1) AAV5-hFIX High Dose (Cohort 2)
Hide Arm/Group Description

AAV5-hFIX 5 × 10E12 gc/kg intravenous single infusion

AAV5-hFIX: AAV5hFIX gene therapy

AAV5-hFIX 2 × 10E13 gc/kg intravenous single infusion

AAV5-hFIX: AAV5hFIX gene therapy
All-Cause Mortality
AAV5-hFIX Low Dose (Cohort 1) AAV5-hFIX High Dose (Cohort 2)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)      0/5 (0.00%)    
Hide Serious Adverse Events
AAV5-hFIX Low Dose (Cohort 1) AAV5-hFIX High Dose (Cohort 2)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/5 (60.00%)      2/5 (40.00%)    
General disorders     
Pyrexia † 1  1/5 (20.00%)  1 0/5 (0.00%)  0
Investigations     
Hepatic Enzyme Increased † 1  1/5 (20.00%)  1 0/5 (0.00%)  0
Alanine Aminotransferase Increased † 1  0/5 (0.00%)  0 1/5 (20.00%)  1
Nervous system disorders     
Myelopathy † 1  0/5 (0.00%)  0 1/5 (20.00%)  1
Renal and urinary disorders     
Renal Colic † 1  1/5 (20.00%)  1 0/5 (0.00%)  0
Calculus Ureteric † 1  1/5 (20.00%)  1 0/5 (0.00%)  0
1
Term from vocabulary, MedDRA (17.1)
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
AAV5-hFIX Low Dose (Cohort 1) AAV5-hFIX High Dose (Cohort 2)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/5 (100.00%)      5/5 (100.00%)    
Blood and lymphatic system disorders     
Splenomegaly † 1  0/5 (0.00%)  0 1/5 (20.00%)  1
Cardiac disorders     
Tachycardia † 1  1/5 (20.00%)  1 0/5 (0.00%)  0
Palpitations † 1  0/5 (0.00%)  0 1/5 (20.00%)  1
Ear and labyrinth disorders     
Vertigo positional † 1  1/5 (20.00%)  1 0/5 (0.00%)  0
Cerumen impaction † 1  0/5 (0.00%)  0 1/5 (20.00%)  1
Eye disorders     
Blepharitis † 1  0/5 (0.00%)  0 1/5 (20.00%)  1
Cataract † 1  1/5 (20.00%)  1 0/5 (0.00%)  0
Gastrointestinal disorders     
Dyspepsia † 1  1/5 (20.00%)  1 0/5 (0.00%)  0
Constipation † 1  1/5 (20.00%)  1 0/5 (0.00%)  0
Diarrhoea † 1  1/5 (20.00%)  1 0/5 (0.00%)  0
Food poisoning † 1  1/5 (20.00%)  1 0/5 (0.00%)  0
Abdominal pain lower † 1  1/5 (20.00%)  1 0/5 (0.00%)  0
Toothache † 1  0/5 (0.00%)  0 1/5 (20.00%)  1
Large intestine polyp † 1  1/5 (20.00%)  1 0/5 (0.00%)  0
Irritable bowel syndrome † 1  1/5 (20.00%)  1 0/5 (0.00%)  0
Abdominal pain † 1  0/5 (0.00%)  0 1/5 (20.00%)  1
Gastrointestinal sounds abnormal † 1  1/5 (20.00%)  1 0/5 (0.00%)  0
Abdominal pain upper † 1  1/5 (20.00%)  1 0/5 (0.00%)  0
Abdominal discomfort † 1  1/5 (20.00%)  1 0/5 (0.00%)  0
Gastrointestinal disorder † 1  1/5 (20.00%)  1 0/5 (0.00%)  0
General disorders     
Pyrexia † 1  1/5 (20.00%)  1 2/5 (40.00%)  2
Influenza like illness † 1  3/5 (60.00%)  3 0/5 (0.00%)  0
Fatigue † 1  1/5 (20.00%)  1 1/5 (20.00%)  1
Peripheral swelling † 1  0/5 (0.00%)  0 1/5 (20.00%)  2
Malaise † 1  1/5 (20.00%)  1 0/5 (0.00%)  0
Pain † 1  1/5 (20.00%)  1 0/5 (0.00%)  0
Drug ineffective † 1  1/5 (20.00%)  1 0/5 (0.00%)  0
Immune system disorders     
Hypersensitivity † 1  1/5 (20.00%)  1 0/5 (0.00%)  0
Infections and infestations     
Nasopharyngitis † 1  1/5 (20.00%)  2 3/5 (60.00%)  8
Influenza † 1  2/5 (40.00%)  2 0/5 (0.00%)  0
Eye infection † 1  0/5 (0.00%)  0 1/5 (20.00%)  2
Cellulitis † 1  0/5 (0.00%)  0 1/5 (20.00%)  1
Upper respiratory tract infection † 1  1/5 (20.00%)  1 0/5 (0.00%)  0
Sinusitis † 1  1/5 (20.00%)  1 0/5 (0.00%)  0
Bronchitis † 1  0/5 (0.00%)  0 1/5 (20.00%)  1
Rhinitis † 1  1/5 (20.00%)  1 0/5 (0.00%)  0
Cystitis † 1  1/5 (20.00%)  1 0/5 (0.00%)  0
Pulpitis dental † 1  0/5 (0.00%)  0 1/5 (20.00%)  1
Oral herpes † 1  1/5 (20.00%)  1 0/5 (0.00%)  0
Laryngitis † 1  0/5 (0.00%)  0 1/5 (20.00%)  1
Herpes zoster † 1  1/5 (20.00%)  1 0/5 (0.00%)  0
Respiratory tract infection † 1  1/5 (20.00%)  1 0/5 (0.00%)  0
Fungal skin infection † 1  0/5 (0.00%)  0 1/5 (20.00%)  1
Ear infection † 1  0/5 (0.00%)  0 1/5 (20.00%)  1
Injury, poisoning and procedural complications     
Fall † 1  1/5 (20.00%)  5 1/5 (20.00%)  1
Upper limb fracture † 1  0/5 (0.00%)  0 1/5 (20.00%)  1
Ulna fracture † 1  1/5 (20.00%)  1 0/5 (0.00%)  0
Tooth fracture † 1  0/5 (0.00%)  0 1/5 (20.00%)  1
Joint injury † 1  0/5 (0.00%)  0 1/5 (20.00%)  1
Hand fracture † 1  0/5 (0.00%)  0 1/5 (20.00%)  1
Bone contusion † 1  1/5 (20.00%)  1 0/5 (0.00%)  0
Injury † 1  1/5 (20.00%)  1 0/5 (0.00%)  0
Muscle strain † 1  1/5 (20.00%)  1 0/5 (0.00%)  0
Arthropod bite † 1  0/5 (0.00%)  0 1/5 (20.00%)  1
Investigations     
Hepatic enzyme increased † 1  0/5 (0.00%)  0 1/5 (20.00%)  1
Haemoglobin decreased † 1  1/5 (20.00%)  2 0/5 (0.00%)  0
Transaminases increased † 1  0/5 (0.00%)  0 1/5 (20.00%)  1
Platelet count decreased † 1  1/5 (20.00%)  1 0/5 (0.00%)  0
Blood urine present † 1  1/5 (20.00%)  1 0/5 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Joint swelling † 1  2/5 (40.00%)  3 2/5 (40.00%)  2
Arthralgia † 1  3/5 (60.00%)  10 0/5 (0.00%)  0
Back pain † 1  1/5 (20.00%)  2 1/5 (20.00%)  3
Musculoskeletal pain † 1  2/5 (40.00%)  4 0/5 (0.00%)  0
Pain in extremity † 1  1/5 (20.00%)  1 1/5 (20.00%)  1
Groin pain † 1  1/5 (20.00%)  1 0/5 (0.00%)  0
Tenosynovitis † 1  1/5 (20.00%)  1 0/5 (0.00%)  0
Synovial cyst † 1  0/5 (0.00%)  0 1/5 (20.00%)  1
Neck pain † 1  1/5 (20.00%)  1 0/5 (0.00%)  0
Musculoskeletal stiffness † 1  0/5 (0.00%)  0 1/5 (20.00%)  1
Intervertebral disc protrusion † 1  1/5 (20.00%)  1 0/5 (0.00%)  0
Nervous system disorders     
Headache † 1  1/5 (20.00%)  1 1/5 (20.00%)  1
Dizziness † 1  2/5 (40.00%)  2 0/5 (0.00%)  0
Nervous system disorder † 1  0/5 (0.00%)  0 1/5 (20.00%)  2
Paraesthesia † 1  0/5 (0.00%)  0 1/5 (20.00%)  1
Hypoaesthesia † 1  0/5 (0.00%)  0 1/5 (20.00%)  1
Psychiatric disorders     
Sleep disorder † 1  1/5 (20.00%)  2 1/5 (20.00%)  1
Anxiety † 1  1/5 (20.00%)  1 1/5 (20.00%)  1
Renal and urinary disorders     
Renal colic † 1  1/5 (20.00%)  1 0/5 (0.00%)  0
Nephrolithiasis † 1  1/5 (20.00%)  1 0/5 (0.00%)  0
Dysuria † 1  1/5 (20.00%)  1 0/5 (0.00%)  0
Reproductive system and breast disorders     
Prostatitis † 1  0/5 (0.00%)  0 1/5 (20.00%)  1
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease † 1  1/5 (20.00%)  1 0/5 (0.00%)  0
Skin and subcutaneous tissue disorders     
Dermatitis atopic † 1  0/5 (0.00%)  0 1/5 (20.00%)  2
Actinic keratosis † 1  1/5 (20.00%)  2 0/5 (0.00%)  0
Rash † 1  0/5 (0.00%)  0 1/5 (20.00%)  1
Eczema † 1  1/5 (20.00%)  1 0/5 (0.00%)  0
Vascular disorders     
Haematoma † 1  0/5 (0.00%)  0 1/5 (20.00%)  2
Lymphoedema † 1  0/5 (0.00%)  0 1/5 (20.00%)  1
1
Term from vocabulary, MedDRA (17.1)
†
Indicates events were collected by systematic assessment
[Not Specified]
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: Study Director
Organization: CSL Behring
Phone: 610-878-4000
EMail: clinicaltrials@cslbehring.com
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: CSL Behring
ClinicalTrials.gov Identifier: NCT02396342    
Other Study ID Numbers: CT-AMT-060-01
First Submitted: March 4, 2015
First Posted: March 24, 2015
Results First Submitted: June 1, 2022
Results First Posted: June 27, 2022
Last Update Posted: June 27, 2022