Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

An Open-label, Nonrandomized Study to Evaluate the Safety and Immunogenicity of Raxibacumab With Reinjection

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: NCT02016963
Recruitment Status : Completed
First Posted : December 20, 2013
Results First Posted : June 25, 2014
Last Update Posted : November 29, 2018
Sponsor:
Collaborators:
GlaxoSmithKline
Emergent BioSolutions
Information provided by (Responsible Party):
Human Genome Sciences Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Therapeutic Treatment of Inhalation Anthrax
Intervention Biological: Raxibacumab
Enrollment 20
Recruitment Details Participants who had received raxibacumab >= 4 months in another HGS study (study # HGS1021-C1064) prior to this study were eligible for enrollment in this study.
Pre-assignment Details  
Arm/Group Title Raxibacumab
Hide Arm/Group Description Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
Period Title: Overall Study
Started 20
Completed 20
Not Completed 0
Arm/Group Title Raxibacumab
Hide Arm/Group Description Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 20 participants
40.6  (13.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
8
  40.0%
Male
12
  60.0%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 20 participants
White 13
Black or African American 7
1.Primary Outcome
Title Number of Participants Who Developed a Positive Anti-raxibacumab Antibody Response
Hide Description Number of participants who developed an positive anti-raxibacumab antibody response during the study were assessed.The antibody response to raxibacumab was assessed using a screening assay (i.e. by electrochemiluminescence counts). Positive samples would be further tested in an inhibition of binding assay to confirm the specificity of binding.
Time Frame From the date of the dose administration of study agent for this study (Day 0) until Day 70
Hide Outcome Measure Data
Hide Analysis Population Description
As-treated population : all participants who received 1 dose of study treatment.
Arm/Group Title Raxibacumab
Hide Arm/Group Description:
Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: Participants
0
2.Secondary Outcome
Title Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) During the Treatment Period
Hide Description An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. This includes worsening (eg, increase in frequency or severity) of pre-existing conditions. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect. Medical or scientific judgment should be exercised in deciding whether reporting is appropriate in other situations. Refer to the General Adverse AE/SAE module for a complete list of AEs and SAEs.
Time Frame From the date of the dose administration of study agent for this study (Day 0) until Day 70
Hide Outcome Measure Data
Hide Analysis Population Description
As-treated population
Arm/Group Title Raxibacumab
Hide Arm/Group Description:
Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: Participants
Any AE 8
Any SAE 0
3.Secondary Outcome
Title Number of Participants With Hematological Toxicities of the Indicated Grade
Hide Description Clinical hematological parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.
Time Frame From the date of the dose administration of study agent for this study (Day 0) until Day 70
Hide Outcome Measure Data
Hide Analysis Population Description
As-treated population
Arm/Group Title Raxibacumab
Hide Arm/Group Description:
Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: Participants
Leukocytosis, Grade 1 0
Leukocytosis, Grade 2 0
Leukocytosis, Grade 3 0
Leukocytosis, Grade 4 0
Leukopenia, Grade 1 5
Leukopenia, Grade 2 0
Leukopenia, Grade 3 0
Leukopenia, Grade 4 0
Lymphopenia, Grade 1 0
Lymphopenia, Grade 2 1
Lymphopenia, Grade 3 0
Lymphopenia, Grade 4 0
Neutropenia, Grade 1 2
Neutropenia, Grade 2 0
Neutropenia, Grade 3 0
Neutropenia, Grade 4 0
Hemoglobin, Grade 1 1
Hemoglobin, Grade 2 0
Hemoglobin, Grade 3 0
Hemoglobin, Grade 4 0
Platelet, Grade 1 0
Platelet, Grade 2 0
Platelet, Grade 3 0
Platelet, Grade 4 0
Prothrombin Time, Grade 1 0
Prothrombin Time, Grade 2 0
Prothrombin Time, Grade 3 0
Prothrombin Time, Grade 4 1
Partial Thromboplastin Time, Grade 1 0
Partial Thromboplastin Time, Grade 2 1
Partial Thromboplastin Time, Grade 3 0
Partial Thromboplastin Time, Grade 4 0
4.Secondary Outcome
Title Number of Participants With at Least a 2-grade Worsening From Baseline in Hematological Toxicities
Hide Description The number of participants with at least a 2-grade worsening from Baseline in hematological toxicities is presented. Clinical hematological parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable. Baseline is defined as the value of the variable measured at Day 0 prior to dosing.
Time Frame From the date of the dose administration of study agent for this study (Day 0) until Day 70
Hide Outcome Measure Data
Hide Analysis Population Description
As-treated population
Arm/Group Title Raxibacumab
Hide Arm/Group Description:
Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: Participants
Leukocytosis, any>=2-grade worsening 0
Leukopenia, any >=2-grade worsening 0
Lymphopenia, any>=2-grade worsening 1
Neutropenia, any >=2-grade worsening 0
Hemoglobin, any>=2-grade worsening 0
Platelet, any>=2-grade worsening 0
Prothrombin Time, any >=2-grade worsening 1
Partial Thromboplastin Time, any>=2grade worsening 1
5.Secondary Outcome
Title Number of Participants With Liver Toxicities of the Indicated Grade
Hide Description Liver function parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.
Time Frame From the date of the dose administration of study agent for this study (Day 0) until Day 70
Hide Outcome Measure Data
Hide Analysis Population Description
As-treated population
Arm/Group Title Raxibacumab
Hide Arm/Group Description:
Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: Participants
Aspartate amino transferase (AST), Grade 1 2
AST, Grade 2 0
AST, Grade 3 0
AST, Grade 4 0
Alanine amino transferase(ALT), Grade 1 1
ALT, Grade 2 1
ALT, Grade 3 0
ALT, Grade 4 0
Gamma-glutayl-transferase (GGT), Grade 1 0
GGT, Grade 2 0
GGT, Grade 3 0
GGT, Grade 4 0
Alkaline Phosphatase, Grade 1 0
Alkaline Phosphatase, Grade 2 0
Alkaline Phosphatase, Grade 3 0
Alkaline Phosphatase, Grade 4 0
Hyperbilirubinemia, Grade 1 0
Hyperbilirubinemia, Grade 2 0
Hyperbilirubinemia, Grade 3 0
Hyperbilirubinemia, Grade 4 0
6.Secondary Outcome
Title Number of Participants With at Least a 2-grade Worsening From Baseline in Liver Toxicities
Hide Description The number of participants with at least a 2-grade worsening from Baseline in liver toxicities is presented. Liver function parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable. Baseline is defined as the value of the variable measured at Day 0 prior to dosing.
Time Frame From the date of the dose administration of study agent for this study (Day 0) until Day 70
Hide Outcome Measure Data
Hide Analysis Population Description
As-treated population
Arm/Group Title Raxibacumab
Hide Arm/Group Description:
Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: Participants
AST, any>=2-grade worsening 0
ALT, any>=2-grade worsening 1
GGT, any>=2-grade worsening 0
Alkaline phosphatase, any>=2-grade worsening 0
Hyperbilirubinemia, any>=2-grade worsening 0
7.Secondary Outcome
Title Number of Participants With Electrolyte Toxicities of the Indicated Grade
Hide Description Electrolyte function parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.
Time Frame From the date of the dose administration of study agent for this study (Day 0) until Day 70
Hide Outcome Measure Data
Hide Analysis Population Description
As-treated population
Arm/Group Title Raxibacumab
Hide Arm/Group Description:
Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: Participants
Hypernatremia, Grade 1 0
Hypernatremia, Grade 2 0
Hypernatremia, Grade 3 0
Hypernatremia, Grade 4 0
Hyponatremia, Grade 1 2
Hyponatremia, Grade 2 0
Hyponatremia, Grade 3 0
Hyponatremia, Grade 4 0
Hyperkalemia, Grade 1 1
Hyperkalemia, Grade 2 0
Hyperkalemia, Grade 3 0
Hyperkalemia, Grade 4 0
Hypokalemia, Grade 1 0
Hypokalemia, Grade 2 0
Hypokalemia, Grade 3 0
Hypokalemia, Grade 4 0
Hypomagnesemia, Grade 1 0
Hypomagnesemia, Grade 2 0
Hypomagnesemia, Grade 3 0
Hypomagnesemia, Grade 4 0
Hypercalcemia, Grade 1 0
Hypercalcemia, Grade 2 0
Hypercalcemia, Grade 3 0
Hypercalcemia, Grade 4 0
Hypocalcemia, Grade 1 0
Hypocalcemia, Grade 2 0
Hypocalcemia, Grade 3 0
Hypocalcemia, Grade 4 0
Hypophosphatemia, Grade 1 1
Hypophosphatemia, Grade 2 0
Hypophosphatemia, Grade 3 0
Hypophosphatemia, Grade 4 0
8.Secondary Outcome
Title Number of Participants With at Least a 2-grade Worsening From Baseline in Electrolyte Toxicities
Hide Description The number of participants with at least a 2-grade worsening from Baseline in electrolyte toxicities is presented. Electrolyte function parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0.Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable. Baseline is defined as the value of the variable measured at Day 0 prior to dosing.
Time Frame From the date of the dose administration of study agent for this study (Day 0) until Day 70
Hide Outcome Measure Data
Hide Analysis Population Description
As-treated population
Arm/Group Title Raxibacumab
Hide Arm/Group Description:
Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: Participants
Hypernatremia, any>=2-grade worsening 0
Hyponatremia, any>=2-grade worsening 0
Hyperkalemia, any>=2-grade worsening 0
Hypokalemia, any>=2-grade worsening 0
Hypomagnesemia, any>=2-grade worsening 0
Hypercalcemia, any>=2-grade worsening 0
Hypocalcemia, any>=2-grade worsening 0
Hypophosphatemia, any>=2-grade worsening 0
9.Secondary Outcome
Title Number of Participants With Other Chemistry Toxicities of the Indicated Grade
Hide Description Other chemistry parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.
Time Frame From the date of the dose administration of study agent for this study (Day 0) until Day 70
Hide Outcome Measure Data
Hide Analysis Population Description
As-treated population
Arm/Group Title Raxibacumab
Hide Arm/Group Description:
Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: Participants
Creatinine, Grade 1 0
Creatinine, Grade 2 0
Creatinine, Grade 3 0
Creatinine, Grade 4 0
Hypoalbuminemia, Grade 1 0
Hypoalbuminemia, Grade 2 0
Hypoalbuminemia, Grade 3 0
Hypoalbuminemia, Grade 4 0
Hyperuricemia, Grade 1 1
Hyperuricemia, Grade 2 0
Hyperuricemia, Grade 3 0
Hyperuricemia, Grade 4 0
Hyperglycemia, Grade 1 4
Hyperglycemia, Grade 2 1
Hyperglycemia, Grade 3 0
Hyperglycemia, Grade 4 0
Hypoglycemia, Grade 1 2
Hypoglycemia, Grade 2 0
Hypoglycemia, Grade 3 0
Hypoglycemia, Grade 4 0
Amylase, Grade 1 3
Amylase, Grade 2 1
Amylase, Grade 3 0
Amylase, Grade 4 0
10.Secondary Outcome
Title Number of Participants With at Least a 2-grade Worsening From Baseline in Other Chemistry Toxicities
Hide Description The number of participants with at least a 2-grade worsening from Baseline in other chemistry toxicities is presented. Other clinical chemistry parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.Baseline is defined as the value of the variable measured at Day 0 prior to dosing.
Time Frame From the date of the dose administration of study agent for this study (Day 0) until Day 70
Hide Outcome Measure Data
Hide Analysis Population Description
As-treated population
Arm/Group Title Raxibacumab
Hide Arm/Group Description:
Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: Participants
Creatinine, any>=2-grade worsening 0
Hypoalbuminemia, any>=2-grade worsening 0
Hyperuricemia, any>=2-grade worsening 0
Hyperglycemia, any>=2-grade worsening 1
Hypoglycemia, any>=2-grade worsening 0
Amylase, any>=2-grade worsening 0
11.Secondary Outcome
Title Number of Participants With Urinalysis Toxicities of the Indicated Grade
Hide Description Urinaysis parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.
Time Frame From the date of the dose administration of study agent for this study (Day 0) until Day 70
Hide Outcome Measure Data
Hide Analysis Population Description
As-treated population
Arm/Group Title Raxibacumab
Hide Arm/Group Description:
Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: Participants
0
12.Secondary Outcome
Title Number of Participants With at Least a 2-grade Worsening From Baseline in Urinalysis Toxicities
Hide Description Urinalysis parameters were assessed using the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables, version 2.0. Grade 1 (Mild): Transient or mild discomfort (< 48 hours); no medical intervention or therapy required. Grade 2 (Moderate): Mild to moderate limitation in activity, some assistance may be needed; no or minimal medical intervention or therapy required. Grade 3 (Severe): Marked limitation in activity, some assistance usually required; medical intervention or therapy required, hospitalizations possible. Grade 4 (Life-threatening): Extreme limitation in activity, significant assistance required; significant medical intervention or therapy required, hospitalization or hospice care probable.Baseline is defined as the value of the variable measured at Day 0 prior to dosing.
Time Frame From the date of the dose administration of study agent for this study (Day 0) until Day 70
Hide Outcome Measure Data
Hide Analysis Population Description
As-treated population
Arm/Group Title Raxibacumab
Hide Arm/Group Description:
Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
Overall Number of Participants Analyzed 20
Measure Type: Number
Unit of Measure: Participants
0
13.Secondary Outcome
Title Mean Raxibacumab Concentration-time Following an IV Infusion Raxibacumab Dose
Hide Description Blood was collected from each participant at the selected times: pre-dose (Day 0), 0.00347 hours (Day 0), 0.3333 hours (Day 0), Day 1, Day 3, Day 7, Day 14, Day 21, Day 28, Day 42, and Day 56 post-dose. Serum specimens were analyzed for raxibacumab using a validated electrochemiluminescense-based assay. The individual serum raxibacumab concentration data were summarized by nominal collection time and treatment group using descriptive statistics
Time Frame From the date of the dose administration of study agent for this study (Day 0) until Day 56
Hide Outcome Measure Data
Hide Analysis Population Description
As-treated population
Arm/Group Title Raxibacumab IV
Hide Arm/Group Description:
Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
Overall Number of Participants Analyzed 20
Mean (Standard Deviation)
Unit of Measure: Micrograms/milliliter (µg/mL)
Pre-dose 1.358  (1.879)
0.00347 hr 979.078  (147.543)
0.3333 hr 865.874  (122.602)
Day 1 784.122  (118.680)
Day 3 580.068  (94.776)
Day 7 418.253  (62.350)
Day 14 300.589  (41.689)
Day 21 238.190  (39.515)
Day 28 208.646  (44.802)
Day 42 131.473  (44.308)
Day 56 96.932  (46.637)
Time Frame Serious adverse events (SAEs) and non-serious AEs were collected from the time the first dose of study agent (Day 0) until Day 70.
Adverse Event Reporting Description SAEs and non-serious AEs were collected in the as-treated population, comprised of all participants randomized to treatment who received one dose of study agent.
 
Arm/Group Title Raxibacumab
Hide Arm/Group Description Participants received their second dose of raxibacumab 40 milligrams/kilogram (mg/kg) by intravenous (IV) infusion. Participants were treated with oral diphenhydramine 50 mg up to 60 minutes prior to infusion of raxibacumab.
All-Cause Mortality
Raxibacumab
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Raxibacumab
Affected / at Risk (%)
Total   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Raxibacumab
Affected / at Risk (%)
Total   8/20 (40.00%) 
Gastrointestinal disorders   
Abdominal pain  1  1/20 (5.00%) 
General disorders   
Pain  1  1/20 (5.00%) 
Infections and infestations   
Upper respiratory tract infection  1  1/20 (5.00%) 
Injury, poisoning and procedural complications   
Contusion  1  1/20 (5.00%) 
Musculoskeletal and connective tissue disorders   
Joint stiffness  1  1/20 (5.00%) 
Nervous system disorders   
Headache  1  3/20 (15.00%) 
Skin and subcutaneous tissue disorders   
Dry skin  1  1/20 (5.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MeDRA
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.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: Human Genome Sciences Inc.
Phone: 866-435-7343
Layout table for additonal information
Responsible Party: Human Genome Sciences Inc.
ClinicalTrials.gov Identifier: NCT02016963     History of Changes
Obsolete Identifiers: NCT03625479
Other Study ID Numbers: HGS1021-C1069
First Submitted: December 16, 2013
First Posted: December 20, 2013
Results First Submitted: March 13, 2014
Results First Posted: June 25, 2014
Last Update Posted: November 29, 2018