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Trial record 1 of 1 for:    Phase IIa Trial of ALXN1007 for the Treatment of Non-criteria Manifestations of Antiphospholipid Syndrome
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Phase IIa Trial of ALXN1007 for the Treatment of Non-criteria Manifestations of Antiphospholipid Syndrome

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: NCT02128269
Recruitment Status : Terminated (Screening discontinued early due to slow patient enrollment)
First Posted : May 1, 2014
Results First Posted : July 13, 2017
Last Update Posted : July 13, 2017
Sponsor:
Information provided by (Responsible Party):
Alexion Pharmaceuticals

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Antiphospholipid (aPL)-Positive
Intervention Biological: Study Drug- ALXN1007
Enrollment 9
Recruitment Details  
Pre-assignment Details  
Arm/Group Title ALXN1007
Hide Arm/Group Description ALXN1007 10 mg/kg IV q 2 weeks x 12 doses
Period Title: Treatment Period
Started 9
Completed 7
Not Completed 2
Reason Not Completed
Adverse Event             1
Physician Decision             1
Period Title: Follow-up
Started 9 [1]
Completed 9
Not Completed 0
[1]
All enrolled patients were followed for 12 weeks after their last infusion of ALXN1007.
Arm/Group Title ALXN1007- Open Label Study
Hide Arm/Group Description

ALXN1007

ALXN1007: 10 mg/kg IV q 2 weeks x 12 doses

Overall Number of Baseline Participants 9
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
<=18 years
0
   0.0%
Between 18 and 65 years
7
  77.8%
>=65 years
2
  22.2%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
Female
3
  33.3%
Male
6
  66.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
7
  77.8%
Unknown or Not Reported
2
  22.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 9 participants
American Indian or Alaska Native
0
   0.0%
Asian
2
  22.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
6
  66.7%
More than one race
0
   0.0%
Unknown or Not Reported
1
  11.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 9 participants
United States 4
Japan 2
Italy 1
France 2
1.Primary Outcome
Title Safety and Tolerability of Intravenous (IV) ALXN1007 as Measured by Percentage of Patients Reporting Adverse Events
Hide Description [Not Specified]
Time Frame Treatment Period (24 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ALXN1007
Hide Arm/Group Description:
ALXN1007 10 mg/kg IV q 2 weeks x 12 doses
Overall Number of Participants Analyzed 9
Measure Type: Count of Participants
Unit of Measure: Participants
8
  88.9%
Time Frame Treatment Period (24 weeks) and Follow-up Period (12 weeks).
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title ALXN1007- Open Label Study
Hide Arm/Group Description

ALXN1007

ALXN1007: 10 mg/kg IV q 2 weeks x 12 doses

All-Cause Mortality
ALXN1007- Open Label Study
Affected / at Risk (%)
Total   0/9 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
ALXN1007- Open Label Study
Affected / at Risk (%)
Total   2/9 (22.22%) 
Hepatobiliary disorders   
Cholestasis *  1/9 (11.11%) 
Liver Cytolysis *  1/9 (11.11%) 
Injury, poisoning and procedural complications   
Lumbar vertebral fracture *  1/9 (11.11%) 
Wrist fracture *  1/9 (11.11%) 
Musculoskeletal and connective tissue disorders   
Lumbar spinal stenosis *  1/9 (11.11%) 
Pregnancy, puerperium and perinatal conditions   
Abortion missed *  1/9 (11.11%) 
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
ALXN1007- Open Label Study
Affected / at Risk (%)
Total   8/9 (88.89%) 
Blood and lymphatic system disorders   
Anaemia *  1/9 (11.11%) 
Antiphospholipid syndrome *  1/9 (11.11%) 
Thrombocytopenia *  1/9 (11.11%) 
Ear and labyrinth disorders   
Tinnitus *  1/9 (11.11%) 
Gastrointestinal disorders   
Abdominal pain *  1/9 (11.11%) 
Colitis *  1/9 (11.11%) 
Enterocolitis *  1/9 (11.11%) 
Gastrooesophageal reflux disease *  1/9 (11.11%) 
Haemorrhoids *  1/9 (11.11%) 
Hypoaesthesia oral *  1/9 (11.11%) 
Nausea *  2/9 (22.22%) 
General disorders   
Oedema peripheral *  1/9 (11.11%) 
Pain *  1/9 (11.11%) 
Infections and infestations   
Bronchitis *  2/9 (22.22%) 
Cystitis *  1/9 (11.11%) 
Gastroenteritis *  1/9 (11.11%) 
Labyrinthitis *  1/9 (11.11%) 
Nasopharyngitis *  1/9 (11.11%) 
Oral Herpes *  1/9 (11.11%) 
Paronychia *  1/9 (11.11%) 
Pharyngitis *  1/9 (11.11%) 
Sinusitis *  1/9 (11.11%) 
Staphylococcal Infection *  1/9 (11.11%) 
Tracheitis *  2/9 (22.22%) 
Upper respiratory tract infection *  4/9 (44.44%) 
Urethritis *  1/9 (11.11%) 
Musculoskeletal and connective tissue disorders   
Back pain *  1/9 (11.11%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Squamous cell carcinoma *  1/9 (11.11%) 
Nervous system disorders   
Carpal tunnel syndrome *  1/9 (11.11%) 
Dizziness *  1/9 (11.11%) 
Hypoaesthesia *  1/9 (11.11%) 
Restless legs syndrome *  1/9 (11.11%) 
Respiratory, thoracic and mediastinal disorders   
Cough *  1/9 (11.11%) 
Epistaxis *  1/9 (11.11%) 
Skin and subcutaneous tissue disorders   
Alopecia *  1/9 (11.11%) 
Vascular disorders   
Varicose vein *  1/9 (11.11%) 
*
Indicates events were collected by non-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.
Publication rights are tied to the completion of the multi-center publication
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Alexion Medical Monitor
Organization: Alexion
Phone: 617-613-1071
EMail: Bert.Yao@alexion.com
Layout table for additonal information
Responsible Party: Alexion Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02128269     History of Changes
Other Study ID Numbers: ALXN1007-APS-201
2013-003588-73 ( EudraCT Number )
First Submitted: April 29, 2014
First Posted: May 1, 2014
Results First Submitted: June 14, 2017
Results First Posted: July 13, 2017
Last Update Posted: July 13, 2017