Trial Outcomes & Findings for Stage 1 Study of ARALAST NP and GLASSIA in A1PI Deficiency (NCT NCT02722304)
NCT ID: NCT02722304
Last Updated: 2021-05-13
Results Overview
Rate of change in lung density was assessed by computed tomography (CT) densitometry. Computed Tomography (CT) scans was used to measure lung density as a quantitative assessment of emphysema progression and treatment efficacy at each of the study visits. CT lung density at the 15th percentile (PD15) is the threshold below which 15% of the voxels have lower densities, and was used as the parameter for estimating the rate of lung density decline. Rate of change in lung density based on Group 1 (ARALAST NP) versus Placebo, Group 3 and Group 4 (GLASSIA) versus Placebo were reported. The safety analysis set used for all the efficacy parameter assessment.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
7 participants
Primary outcome timeframe
Baseline, Early termination of the study (approximately 22 months)
Results posted on
2021-05-13
Participant Flow
The study was conducted at 4 study centers in the United States (3) and Australia (1) between 02 November 2016 (first participant first visit) and 14 September 2018 (last participant last visit).
A total of 22 participants were screened for entry of study, of these, 15 participants were considered screen failures. Remaining 7 participants were enrolled and randomized in the study.
Participant milestones
| Measure |
ARALAST NP 60 mg/kg (Group 1)
Participants received 60 milligram per kilogram body weight per week (mg/kg BW/week) of ARALAST NP intravenous (IV) infusion for a total of 96 weeks.
|
ARALAST NP 120 mg/kg (Group 2)
Participants received 120 mg/kg BW/week of ARALAST NP IV infusion for a total of 96 weeks.
|
GLASSIA 60 mg/kg (Group 3)
Participants received 60 mg/kg BW/week of GLASSIA IV infusion for a total of 96 weeks.
|
GLASSIA 120 mg/kg (Group 4)
Participants received 120 mg/kg BW/week of GLASSIA IV infusion for a total of 96 weeks.
|
Placebo (Group 5)
Participants received 6 milliliter per kilogram body weight per week (ml/kg BW/week) of placebo (human albumin two percent \[%\]) in normal saline for a total of 96 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
0
|
2
|
2
|
2
|
|
Overall Study
Treated
|
1
|
0
|
1
|
1
|
2
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
2
|
2
|
2
|
Reasons for withdrawal
| Measure |
ARALAST NP 60 mg/kg (Group 1)
Participants received 60 milligram per kilogram body weight per week (mg/kg BW/week) of ARALAST NP intravenous (IV) infusion for a total of 96 weeks.
|
ARALAST NP 120 mg/kg (Group 2)
Participants received 120 mg/kg BW/week of ARALAST NP IV infusion for a total of 96 weeks.
|
GLASSIA 60 mg/kg (Group 3)
Participants received 60 mg/kg BW/week of GLASSIA IV infusion for a total of 96 weeks.
|
GLASSIA 120 mg/kg (Group 4)
Participants received 120 mg/kg BW/week of GLASSIA IV infusion for a total of 96 weeks.
|
Placebo (Group 5)
Participants received 6 milliliter per kilogram body weight per week (ml/kg BW/week) of placebo (human albumin two percent \[%\]) in normal saline for a total of 96 weeks.
|
|---|---|---|---|---|---|
|
Overall Study
Study Terminated by Sponsor
|
1
|
0
|
2
|
1
|
1
|
|
Overall Study
Other
|
0
|
0
|
0
|
1
|
1
|
Baseline Characteristics
Stage 1 Study of ARALAST NP and GLASSIA in A1PI Deficiency
Baseline characteristics by cohort
| Measure |
ARALAST NP 60 mg/kg (Group 1)
n=1 Participants
Participants received 60 milligram per kilogram body weight per week (mg/kg BW/week) of ARALAST NP intravenous (IV) infusion for a total of 96 weeks.
|
ARALAST NP 120 mg/kg (Group 2)
Participants received 120 mg/kg BW/week of ARALAST NP IV infusion for a total of 96 weeks.
|
GLASSIA 60 mg/kg (Group 3)
n=1 Participants
Participants received 60 mg/kg BW/week of GLASSIA IV infusion for a total of 96 weeks.
|
GLASSIA 120 mg/kg (Group 4)
n=1 Participants
Participants received 120 mg/kg BW/week of GLASSIA IV infusion for a total of 96 weeks.
|
Placebo (Group 5)
n=2 Participants
Participants received 6 milliliter per kilogram body weight per week (ml/kg BW/week) of placebo (human albumin two percent \[%\]) in normal saline for a total of 96 weeks.
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
62.0 Years
STANDARD_DEVIATION NA • n=5 Participants
|
—
|
65.0 Years
STANDARD_DEVIATION NA • n=5 Participants
|
68.0 Years
STANDARD_DEVIATION NA • n=4 Participants
|
46.0 Years
STANDARD_DEVIATION 4.24 • n=21 Participants
|
57.4 Years
STANDARD_DEVIATION 10.83 • n=8 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
—
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
—
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
—
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
—
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline, Early termination of the study (approximately 22 months)Population: Study was early terminated due to low and slow rate of enrollment, hence, data was not collected for this efficacy endpoint.
Rate of change in lung density was assessed by computed tomography (CT) densitometry. Computed Tomography (CT) scans was used to measure lung density as a quantitative assessment of emphysema progression and treatment efficacy at each of the study visits. CT lung density at the 15th percentile (PD15) is the threshold below which 15% of the voxels have lower densities, and was used as the parameter for estimating the rate of lung density decline. Rate of change in lung density based on Group 1 (ARALAST NP) versus Placebo, Group 3 and Group 4 (GLASSIA) versus Placebo were reported. The safety analysis set used for all the efficacy parameter assessment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Early termination of the study (approximately 22 months)Population: Study was early terminated due to low and slow rate of enrollment, hence, data was not collected for this efficacy endpoint.
Rate of change in lung density was assessed by computed tomography (CT) densitometry for each treatment group. Computed Tomography (CT) scans was used to measure lung density as a quantitative assessment of emphysema progression and treatment efficacy at each of the study visits. The safety analysis set used for all the efficacy parameter assessment.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Early termination of the study (approximately 22 months)Population: Study was early terminated due to low and slow rate of enrollment, hence, data was not collected for this efficacy endpoint.
Mean steady state trough concentration of antigenic and functional alpha1-proteinase inhibitor (a1pi) for ARALAST NP and GLASSIA at each dose level was reported.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From start of study treatment up to early termination of the study (approximately 22 months)Population: SAS included all participants who had received any amount of IP or placebo, regardless of protocol deviations or non-adherence to the study procedures. Analysis was performed according to the treatment regimen received regardless of the randomized treatment regimen.
An Adverse event (AE) was defined as any untoward medical occurrence in a participant administered an IP that does not necessarily have a causal relationship with the treatment. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were defined as AEs with a start date on or after the first dose of double-blind investigational product or a start date before the date of the first dose of double-blind investigational product that increased in severity or after the date of the first dose. TEAE related to Investigational Product (IP) and Study Procedures (SP) were considered. A non-serious AE is an AE that does not meet the criteria of an SAE. Number of events with related and unrelated serious and non-serious TEAE were reported.
Outcome measures
| Measure |
ARALAST NP 60 mg/kg Versus Placebo
n=1 Participants
Participants received 60 milligram per kilogram body weight per week (mg/kg BW/week) of ARALAST NP intravenous (IV) infusion and 6 milliliter per kilogram body weight per week (ml/kg BW/week) of placebo (human albumin two percent \[%\]) in normal saline for a total of 96 weeks.
|
GLASSIA 60 mg/kg Versus Placebo
n=1 Participants
Participants received 60 mg/kg BW/week of GLASSIA IV infusion and 6 ml/kg BW/week of placebo (human albumin two %) in normal saline for a total of 96 weeks.
|
GLASSIA 120 mg/kg Versus Placebo
n=1 Participants
Participants received 120 mg/kg BW/week of GLASSIA IV infusion and 6 ml/kg BW/week of placebo (human albumin two %) in normal saline for a total of 96 weeks.
|
Placebo (Group 5)
n=2 Participants
Participants received 6 milliliter per kilogram body weight per week (ml/kg BW/week) of placebo (human albumin two percent \[%\]) in normal saline for a total of 96 weeks.
|
|---|---|---|---|---|
|
Number of Events With Related and Unrelated Serious and Non-Serious Treatment Emergent Adverse Event (TEAE)
Serious TEAE: Events Related to IP
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
|
Number of Events With Related and Unrelated Serious and Non-Serious Treatment Emergent Adverse Event (TEAE)
Non-serious TEAE: Events Related to IP
|
0 Events
|
0 Events
|
0 Events
|
19 Events
|
|
Number of Events With Related and Unrelated Serious and Non-Serious Treatment Emergent Adverse Event (TEAE)
Serious TEAE: Events Related to SP
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
|
Number of Events With Related and Unrelated Serious and Non-Serious Treatment Emergent Adverse Event (TEAE)
Non-serious TEAE: Events Related to SP
|
0 Events
|
0 Events
|
0 Events
|
1 Events
|
|
Number of Events With Related and Unrelated Serious and Non-Serious Treatment Emergent Adverse Event (TEAE)
Serious TEAE: Unrelated Events
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
|
Number of Events With Related and Unrelated Serious and Non-Serious Treatment Emergent Adverse Event (TEAE)
Non-serious TEAE: Unrelated Events
|
2 Events
|
0 Events
|
0 Events
|
5 Events
|
SECONDARY outcome
Timeframe: From start of study treatment up to early termination of the study (approximately 22 months)Population: SAS included all participants who had received any amount of IP or placebo, regardless of protocol deviations or non-adherence to the study procedures. Analysis was performed according to the treatment regimen received regardless of the randomized treatment regimen.
An Adverse event (AE) was defined as any untoward medical occurrence in a participant administered an IP that does not necessarily have a causal relationship with the treatment. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were defined as AEs with a start date on or after the first dose of double-blind investigational product or a start date before the date of the first dose of double-blind investigational product that increased in severity or after the date of the first dose. A non-serious AE is an AE that does not meet the criteria of an SAE. TEAE related to IP and Study Procedures were considered. Percentage of participants with related and unrelated serious and non-serious TEAE were reported.
Outcome measures
| Measure |
ARALAST NP 60 mg/kg Versus Placebo
n=1 Participants
Participants received 60 milligram per kilogram body weight per week (mg/kg BW/week) of ARALAST NP intravenous (IV) infusion and 6 milliliter per kilogram body weight per week (ml/kg BW/week) of placebo (human albumin two percent \[%\]) in normal saline for a total of 96 weeks.
|
GLASSIA 60 mg/kg Versus Placebo
n=1 Participants
Participants received 60 mg/kg BW/week of GLASSIA IV infusion and 6 ml/kg BW/week of placebo (human albumin two %) in normal saline for a total of 96 weeks.
|
GLASSIA 120 mg/kg Versus Placebo
n=1 Participants
Participants received 120 mg/kg BW/week of GLASSIA IV infusion and 6 ml/kg BW/week of placebo (human albumin two %) in normal saline for a total of 96 weeks.
|
Placebo (Group 5)
n=2 Participants
Participants received 6 milliliter per kilogram body weight per week (ml/kg BW/week) of placebo (human albumin two percent \[%\]) in normal saline for a total of 96 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants With Related and Unrelated Serious and Non-Serious Treatment Emergent Adverse Events (TEAE's)
Non-Serious TEAE: Unrelated
|
100 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
100 Percentage of Participants
|
|
Percentage of Participants With Related and Unrelated Serious and Non-Serious Treatment Emergent Adverse Events (TEAE's)
Serious TEAE: Related to IP
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Related and Unrelated Serious and Non-Serious Treatment Emergent Adverse Events (TEAE's)
Non-Serious TEAE: Related to IP
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
50 Percentage of Participants
|
|
Percentage of Participants With Related and Unrelated Serious and Non-Serious Treatment Emergent Adverse Events (TEAE's)
Serious TEAE: Related to SP
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Related and Unrelated Serious and Non-Serious Treatment Emergent Adverse Events (TEAE's)
Non-Serious TEAE: Related to SP
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
50 Percentage of Participants
|
|
Percentage of Participants With Related and Unrelated Serious and Non-Serious Treatment Emergent Adverse Events (TEAE's)
Serious TEAE: Unrelated
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
SECONDARY outcome
Timeframe: From start of study treatment up to early termination of the study (approximately 22 months)Population: SAS included all participants who had received any amount of IP or placebo, regardless of protocol deviations or non-adherence to the study procedures. Analysis was performed according to the treatment regimen received regardless of the ( randomized treatment regimen.
An Adverse event (AE) was defined as any untoward medical occurrence in a participant administered an IP that does not necessarily have a causal relationship with the treatment. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were defined as AEs with a start date on or after the first dose of double-blind investigational product or a start date before the date of the first dose of double-blind investigational product that increased in severity or after the date of the first dose. A non-serious AE is an AE that does not meet the criteria of an SAE. TEAEs were temporally related to treatment administration (ie, occurred within 72 hours following the end of the infusion). TEAE Related to IP were considered.
Outcome measures
| Measure |
ARALAST NP 60 mg/kg Versus Placebo
n=1 Participants
Participants received 60 milligram per kilogram body weight per week (mg/kg BW/week) of ARALAST NP intravenous (IV) infusion and 6 milliliter per kilogram body weight per week (ml/kg BW/week) of placebo (human albumin two percent \[%\]) in normal saline for a total of 96 weeks.
|
GLASSIA 60 mg/kg Versus Placebo
n=1 Participants
Participants received 60 mg/kg BW/week of GLASSIA IV infusion and 6 ml/kg BW/week of placebo (human albumin two %) in normal saline for a total of 96 weeks.
|
GLASSIA 120 mg/kg Versus Placebo
n=1 Participants
Participants received 120 mg/kg BW/week of GLASSIA IV infusion and 6 ml/kg BW/week of placebo (human albumin two %) in normal saline for a total of 96 weeks.
|
Placebo (Group 5)
n=2 Participants
Participants received 6 milliliter per kilogram body weight per week (ml/kg BW/week) of placebo (human albumin two percent \[%\]) in normal saline for a total of 96 weeks.
|
|---|---|---|---|---|
|
Number of Events With Temporally Related Serious and Non-Serious Treatment Emergent Adverse Events (AEs)
Temporally Serious TEAE Related to IP
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
|
Number of Events With Temporally Related Serious and Non-Serious Treatment Emergent Adverse Events (AEs)
Temporally Non-Serious TEAE Related to IP
|
0 Events
|
0 Events
|
0 Events
|
17 Events
|
SECONDARY outcome
Timeframe: From start of study treatment up to early termination of the study (approximately 22 months)Population: SAS included all participants who had received any amount of IP or placebo, regardless of protocol deviations or non-adherence to the study procedures. Analysis was performed according to the treatment regimen received regardless of the randomized treatment regimen.
An Adverse event (AE) was defined as any untoward medical occurrence in a participant administered an IP that does not necessarily have a causal relationship with the treatment. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAEs were defined as AEs with a start date on or after the first dose of double-blind investigational product or a start date before the date of the first dose of double-blind investigational product that increased in severity or after the date of the first dose. A non-serious AE is an AE that does not meet the criteria of an SAE. TEAEs were temporally related to treatment administration (ie, occurred within 72 hours following the end of the infusion). TEAE Related to IP were considered.
Outcome measures
| Measure |
ARALAST NP 60 mg/kg Versus Placebo
n=1 Participants
Participants received 60 milligram per kilogram body weight per week (mg/kg BW/week) of ARALAST NP intravenous (IV) infusion and 6 milliliter per kilogram body weight per week (ml/kg BW/week) of placebo (human albumin two percent \[%\]) in normal saline for a total of 96 weeks.
|
GLASSIA 60 mg/kg Versus Placebo
n=1 Participants
Participants received 60 mg/kg BW/week of GLASSIA IV infusion and 6 ml/kg BW/week of placebo (human albumin two %) in normal saline for a total of 96 weeks.
|
GLASSIA 120 mg/kg Versus Placebo
n=1 Participants
Participants received 120 mg/kg BW/week of GLASSIA IV infusion and 6 ml/kg BW/week of placebo (human albumin two %) in normal saline for a total of 96 weeks.
|
Placebo (Group 5)
n=2 Participants
Participants received 6 milliliter per kilogram body weight per week (ml/kg BW/week) of placebo (human albumin two percent \[%\]) in normal saline for a total of 96 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants With Temporally Related Serious and Non-Serious Treatment Emergent Adverse Events (AEs)
Temporally Serious TEAE Related to IP
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
|
Percentage of Participants With Temporally Related Serious and Non-Serious Treatment Emergent Adverse Events (AEs)
Temporally Non-Serious TEAE Related to IP
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
50 Percentage of Participants
|
SECONDARY outcome
Timeframe: From start of study treatment up to early termination of the study (approximately 22 months)Population: SAS included all participants who had received any amount of investigational product (IP) or placebo, regardless of protocol deviations or non-adherence to the study procedures. Analysis was performed according to the treatment regimen received regardless of the randomized treatment regimen.
An Adverse Reactions (ARs) plus suspected adverse reaction is any adverse event which met any of the following criteria: an adverse event that began during infusion or within 72 hours following the end of IP infusion; an adverse event considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration; an adverse event for which causality assessment was missing or indeterminate. Adverse reaction included both serious and non-serious ARs.
Outcome measures
| Measure |
ARALAST NP 60 mg/kg Versus Placebo
n=1 Participants
Participants received 60 milligram per kilogram body weight per week (mg/kg BW/week) of ARALAST NP intravenous (IV) infusion and 6 milliliter per kilogram body weight per week (ml/kg BW/week) of placebo (human albumin two percent \[%\]) in normal saline for a total of 96 weeks.
|
GLASSIA 60 mg/kg Versus Placebo
n=1 Participants
Participants received 60 mg/kg BW/week of GLASSIA IV infusion and 6 ml/kg BW/week of placebo (human albumin two %) in normal saline for a total of 96 weeks.
|
GLASSIA 120 mg/kg Versus Placebo
n=1 Participants
Participants received 120 mg/kg BW/week of GLASSIA IV infusion and 6 ml/kg BW/week of placebo (human albumin two %) in normal saline for a total of 96 weeks.
|
Placebo (Group 5)
n=2 Participants
Participants received 6 milliliter per kilogram body weight per week (ml/kg BW/week) of placebo (human albumin two percent \[%\]) in normal saline for a total of 96 weeks.
|
|---|---|---|---|---|
|
Number of Events With Suspected Adverse Reactions or Serious and Non-Serious Adverse Reactions (ARs)
Suspected ARs or Non-serious ARs
|
1 Events
|
0 Events
|
0 Events
|
24 Events
|
|
Number of Events With Suspected Adverse Reactions or Serious and Non-Serious Adverse Reactions (ARs)
Suspected ARs or Serious ARs
|
0 Events
|
0 Events
|
0 Events
|
0 Events
|
SECONDARY outcome
Timeframe: From start of study treatment up to early termination of the study (approximately 22 months)Population: SAS included all participants who had received any amount of IP or placebo, regardless of protocol deviations or non-adherence to the study procedures. Analysis was performed according to the treatment regimen received regardless of the randomized treatment regimen.
An Adverse Reactions (AR) plus suspected adverse reaction is any adverse event which met any of the following criteria: an adverse event that began during infusion or within 72 hours following the end of IP infusion; an adverse event considered by either the investigator and/or the sponsor to be possibly or probably related to IP administration; an adverse event for which causality assessment was missing or indeterminate. Adverse reaction included both serious and non-serious ARs.
Outcome measures
| Measure |
ARALAST NP 60 mg/kg Versus Placebo
n=1 Participants
Participants received 60 milligram per kilogram body weight per week (mg/kg BW/week) of ARALAST NP intravenous (IV) infusion and 6 milliliter per kilogram body weight per week (ml/kg BW/week) of placebo (human albumin two percent \[%\]) in normal saline for a total of 96 weeks.
|
GLASSIA 60 mg/kg Versus Placebo
n=1 Participants
Participants received 60 mg/kg BW/week of GLASSIA IV infusion and 6 ml/kg BW/week of placebo (human albumin two %) in normal saline for a total of 96 weeks.
|
GLASSIA 120 mg/kg Versus Placebo
n=1 Participants
Participants received 120 mg/kg BW/week of GLASSIA IV infusion and 6 ml/kg BW/week of placebo (human albumin two %) in normal saline for a total of 96 weeks.
|
Placebo (Group 5)
n=2 Participants
Participants received 6 milliliter per kilogram body weight per week (ml/kg BW/week) of placebo (human albumin two percent \[%\]) in normal saline for a total of 96 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants With Suspected Adverse Reactions or Serious and Non-Serious Adverse Reactions (ARs)
Suspected ARs or Non-serious ARs
|
100 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
50 Percentage of Participants
|
|
Percentage of Participants With Suspected Adverse Reactions or Serious and Non-Serious Adverse Reactions (ARs)
Suspected ARs or Serious ARs
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
SECONDARY outcome
Timeframe: From start of study treatment up to early termination of the study (approximately 22 months)Population: SAS included all participants who had received any amount of IP or placebo, regardless of protocol deviations or non-adherence to the study procedures. Analysis was performed according to the treatment regimen received regardless of the randomized treatment regimen.
An Adverse event (AE) was defined as any untoward medical occurrence in a participant administered an IP that does not necessarily have a causal relationship with the treatment. Number of infusions for which the infusion rate was reduced and/or the infusion interrupted or stopped due to adverse events (AEs) were reported.
Outcome measures
| Measure |
ARALAST NP 60 mg/kg Versus Placebo
n=1 Participants
Participants received 60 milligram per kilogram body weight per week (mg/kg BW/week) of ARALAST NP intravenous (IV) infusion and 6 milliliter per kilogram body weight per week (ml/kg BW/week) of placebo (human albumin two percent \[%\]) in normal saline for a total of 96 weeks.
|
GLASSIA 60 mg/kg Versus Placebo
n=1 Participants
Participants received 60 mg/kg BW/week of GLASSIA IV infusion and 6 ml/kg BW/week of placebo (human albumin two %) in normal saline for a total of 96 weeks.
|
GLASSIA 120 mg/kg Versus Placebo
n=1 Participants
Participants received 120 mg/kg BW/week of GLASSIA IV infusion and 6 ml/kg BW/week of placebo (human albumin two %) in normal saline for a total of 96 weeks.
|
Placebo (Group 5)
n=2 Participants
Participants received 6 milliliter per kilogram body weight per week (ml/kg BW/week) of placebo (human albumin two percent \[%\]) in normal saline for a total of 96 weeks.
|
|---|---|---|---|---|
|
Percentage of Participants With at Least One Infusion Rate Change or Infusion Interruption or Stopped Due to AEs
Participantswith at Least 1 Infusion Interruption
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
50 Percentage of Participants
|
|
Percentage of Participants With at Least One Infusion Rate Change or Infusion Interruption or Stopped Due to AEs
Participants with at Least 1 Infusion Rate Change
|
0 Percentage of Participants
|
0 Percentage of Participants
|
0 Percentage of Participants
|
50 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline, Early termination of the study (approximately 22 months)Population: SAS included all participants who had received any amount of IP or placebo, regardless of protocol deviations or non-adherence to the study procedures. Analysis was performed according to the treatment regimen received regardless of the randomized treatment regimen.
Number of participants who developed anti- A1PI antibodies following treatment with ARALAST NP or GLASSIA were reported. Anti-A1PI binding antibody were determined for the samples that tested positive or negative at each assessment time point.
Outcome measures
| Measure |
ARALAST NP 60 mg/kg Versus Placebo
n=1 Participants
Participants received 60 milligram per kilogram body weight per week (mg/kg BW/week) of ARALAST NP intravenous (IV) infusion and 6 milliliter per kilogram body weight per week (ml/kg BW/week) of placebo (human albumin two percent \[%\]) in normal saline for a total of 96 weeks.
|
GLASSIA 60 mg/kg Versus Placebo
n=1 Participants
Participants received 60 mg/kg BW/week of GLASSIA IV infusion and 6 ml/kg BW/week of placebo (human albumin two %) in normal saline for a total of 96 weeks.
|
GLASSIA 120 mg/kg Versus Placebo
n=1 Participants
Participants received 120 mg/kg BW/week of GLASSIA IV infusion and 6 ml/kg BW/week of placebo (human albumin two %) in normal saline for a total of 96 weeks.
|
Placebo (Group 5)
n=2 Participants
Participants received 6 milliliter per kilogram body weight per week (ml/kg BW/week) of placebo (human albumin two percent \[%\]) in normal saline for a total of 96 weeks.
|
|---|---|---|---|---|
|
Number of Participants Who Developed Anti-A1PI Antibodies Following Treatment With ARALAST NP or GLASSIA
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
ARALAST NP 60 mg/kg (Group 1)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
ARALAST NP 120 mg/kg (Group 2)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
GLASSIA 60 mg/kg (Group 3)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
GLASSIA 120 mg/kg (Group 4)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo (Group 5)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
ARALAST NP 60 mg/kg (Group 1)
n=1 participants at risk
Participants received 60 milligram per kilogram body weight per week (mg/kg BW/week) of ARALAST NP intravenous (IV) infusion for a total of 96 weeks.
|
ARALAST NP 120 mg/kg (Group 2)
Participants received 120 mg/kg BW/week of ARALAST NP IV infusion for a total of 96 weeks.
|
GLASSIA 60 mg/kg (Group 3)
n=1 participants at risk
Participants received 60 mg/kg BW/week of GLASSIA IV infusion for a total of 96 weeks.
|
GLASSIA 120 mg/kg (Group 4)
n=1 participants at risk
Participants received 120 mg/kg BW/week of GLASSIA IV infusion for a total of 96 weeks.
|
Placebo (Group 5)
n=2 participants at risk
Participants received 6 milliliter per kilogram body weight per week (ml/kg BW/week) of placebo (human albumin two percent \[%\]) in normal saline for a total of 96 weeks.
|
|---|---|---|---|---|---|
|
Eye disorders
Right Eye Retinal Detachment
|
100.0%
1/1 • Number of events 1 • From start of study treatment up to early termination of the study (approximately 22 months)
Study was terminated early. One arm/ group (ARALAST NP 120 mg/kg (Group 2)) did not have any participants randomized to it at the time of the study termination. Therefore there are zero participants at risk. This applies to the following fields, below for the ARALAST NP 120 mg/kg (Group 2) arm/group: - participants at risk for Serious Adverse Events - participants at risk for All-Cause Mortality - participants at risk for Other (Not Including Serious) Adverse Events
|
—
0/0 • From start of study treatment up to early termination of the study (approximately 22 months)
Study was terminated early. One arm/ group (ARALAST NP 120 mg/kg (Group 2)) did not have any participants randomized to it at the time of the study termination. Therefore there are zero participants at risk. This applies to the following fields, below for the ARALAST NP 120 mg/kg (Group 2) arm/group: - participants at risk for Serious Adverse Events - participants at risk for All-Cause Mortality - participants at risk for Other (Not Including Serious) Adverse Events
|
0.00%
0/1 • From start of study treatment up to early termination of the study (approximately 22 months)
Study was terminated early. One arm/ group (ARALAST NP 120 mg/kg (Group 2)) did not have any participants randomized to it at the time of the study termination. Therefore there are zero participants at risk. This applies to the following fields, below for the ARALAST NP 120 mg/kg (Group 2) arm/group: - participants at risk for Serious Adverse Events - participants at risk for All-Cause Mortality - participants at risk for Other (Not Including Serious) Adverse Events
|
0.00%
0/1 • From start of study treatment up to early termination of the study (approximately 22 months)
Study was terminated early. One arm/ group (ARALAST NP 120 mg/kg (Group 2)) did not have any participants randomized to it at the time of the study termination. Therefore there are zero participants at risk. This applies to the following fields, below for the ARALAST NP 120 mg/kg (Group 2) arm/group: - participants at risk for Serious Adverse Events - participants at risk for All-Cause Mortality - participants at risk for Other (Not Including Serious) Adverse Events
|
0.00%
0/2 • From start of study treatment up to early termination of the study (approximately 22 months)
Study was terminated early. One arm/ group (ARALAST NP 120 mg/kg (Group 2)) did not have any participants randomized to it at the time of the study termination. Therefore there are zero participants at risk. This applies to the following fields, below for the ARALAST NP 120 mg/kg (Group 2) arm/group: - participants at risk for Serious Adverse Events - participants at risk for All-Cause Mortality - participants at risk for Other (Not Including Serious) Adverse Events
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • From start of study treatment up to early termination of the study (approximately 22 months)
Study was terminated early. One arm/ group (ARALAST NP 120 mg/kg (Group 2)) did not have any participants randomized to it at the time of the study termination. Therefore there are zero participants at risk. This applies to the following fields, below for the ARALAST NP 120 mg/kg (Group 2) arm/group: - participants at risk for Serious Adverse Events - participants at risk for All-Cause Mortality - participants at risk for Other (Not Including Serious) Adverse Events
|
—
0/0 • From start of study treatment up to early termination of the study (approximately 22 months)
Study was terminated early. One arm/ group (ARALAST NP 120 mg/kg (Group 2)) did not have any participants randomized to it at the time of the study termination. Therefore there are zero participants at risk. This applies to the following fields, below for the ARALAST NP 120 mg/kg (Group 2) arm/group: - participants at risk for Serious Adverse Events - participants at risk for All-Cause Mortality - participants at risk for Other (Not Including Serious) Adverse Events
|
0.00%
0/1 • From start of study treatment up to early termination of the study (approximately 22 months)
Study was terminated early. One arm/ group (ARALAST NP 120 mg/kg (Group 2)) did not have any participants randomized to it at the time of the study termination. Therefore there are zero participants at risk. This applies to the following fields, below for the ARALAST NP 120 mg/kg (Group 2) arm/group: - participants at risk for Serious Adverse Events - participants at risk for All-Cause Mortality - participants at risk for Other (Not Including Serious) Adverse Events
|
0.00%
0/1 • From start of study treatment up to early termination of the study (approximately 22 months)
Study was terminated early. One arm/ group (ARALAST NP 120 mg/kg (Group 2)) did not have any participants randomized to it at the time of the study termination. Therefore there are zero participants at risk. This applies to the following fields, below for the ARALAST NP 120 mg/kg (Group 2) arm/group: - participants at risk for Serious Adverse Events - participants at risk for All-Cause Mortality - participants at risk for Other (Not Including Serious) Adverse Events
|
50.0%
1/2 • Number of events 13 • From start of study treatment up to early termination of the study (approximately 22 months)
Study was terminated early. One arm/ group (ARALAST NP 120 mg/kg (Group 2)) did not have any participants randomized to it at the time of the study termination. Therefore there are zero participants at risk. This applies to the following fields, below for the ARALAST NP 120 mg/kg (Group 2) arm/group: - participants at risk for Serious Adverse Events - participants at risk for All-Cause Mortality - participants at risk for Other (Not Including Serious) Adverse Events
|
|
Nervous system disorders
Nausea
|
0.00%
0/1 • From start of study treatment up to early termination of the study (approximately 22 months)
Study was terminated early. One arm/ group (ARALAST NP 120 mg/kg (Group 2)) did not have any participants randomized to it at the time of the study termination. Therefore there are zero participants at risk. This applies to the following fields, below for the ARALAST NP 120 mg/kg (Group 2) arm/group: - participants at risk for Serious Adverse Events - participants at risk for All-Cause Mortality - participants at risk for Other (Not Including Serious) Adverse Events
|
—
0/0 • From start of study treatment up to early termination of the study (approximately 22 months)
Study was terminated early. One arm/ group (ARALAST NP 120 mg/kg (Group 2)) did not have any participants randomized to it at the time of the study termination. Therefore there are zero participants at risk. This applies to the following fields, below for the ARALAST NP 120 mg/kg (Group 2) arm/group: - participants at risk for Serious Adverse Events - participants at risk for All-Cause Mortality - participants at risk for Other (Not Including Serious) Adverse Events
|
0.00%
0/1 • From start of study treatment up to early termination of the study (approximately 22 months)
Study was terminated early. One arm/ group (ARALAST NP 120 mg/kg (Group 2)) did not have any participants randomized to it at the time of the study termination. Therefore there are zero participants at risk. This applies to the following fields, below for the ARALAST NP 120 mg/kg (Group 2) arm/group: - participants at risk for Serious Adverse Events - participants at risk for All-Cause Mortality - participants at risk for Other (Not Including Serious) Adverse Events
|
0.00%
0/1 • From start of study treatment up to early termination of the study (approximately 22 months)
Study was terminated early. One arm/ group (ARALAST NP 120 mg/kg (Group 2)) did not have any participants randomized to it at the time of the study termination. Therefore there are zero participants at risk. This applies to the following fields, below for the ARALAST NP 120 mg/kg (Group 2) arm/group: - participants at risk for Serious Adverse Events - participants at risk for All-Cause Mortality - participants at risk for Other (Not Including Serious) Adverse Events
|
50.0%
1/2 • Number of events 6 • From start of study treatment up to early termination of the study (approximately 22 months)
Study was terminated early. One arm/ group (ARALAST NP 120 mg/kg (Group 2)) did not have any participants randomized to it at the time of the study termination. Therefore there are zero participants at risk. This applies to the following fields, below for the ARALAST NP 120 mg/kg (Group 2) arm/group: - participants at risk for Serious Adverse Events - participants at risk for All-Cause Mortality - participants at risk for Other (Not Including Serious) Adverse Events
|
|
Skin and subcutaneous tissue disorders
CONTACT DERMATITIS
|
0.00%
0/1 • From start of study treatment up to early termination of the study (approximately 22 months)
Study was terminated early. One arm/ group (ARALAST NP 120 mg/kg (Group 2)) did not have any participants randomized to it at the time of the study termination. Therefore there are zero participants at risk. This applies to the following fields, below for the ARALAST NP 120 mg/kg (Group 2) arm/group: - participants at risk for Serious Adverse Events - participants at risk for All-Cause Mortality - participants at risk for Other (Not Including Serious) Adverse Events
|
—
0/0 • From start of study treatment up to early termination of the study (approximately 22 months)
Study was terminated early. One arm/ group (ARALAST NP 120 mg/kg (Group 2)) did not have any participants randomized to it at the time of the study termination. Therefore there are zero participants at risk. This applies to the following fields, below for the ARALAST NP 120 mg/kg (Group 2) arm/group: - participants at risk for Serious Adverse Events - participants at risk for All-Cause Mortality - participants at risk for Other (Not Including Serious) Adverse Events
|
0.00%
0/1 • From start of study treatment up to early termination of the study (approximately 22 months)
Study was terminated early. One arm/ group (ARALAST NP 120 mg/kg (Group 2)) did not have any participants randomized to it at the time of the study termination. Therefore there are zero participants at risk. This applies to the following fields, below for the ARALAST NP 120 mg/kg (Group 2) arm/group: - participants at risk for Serious Adverse Events - participants at risk for All-Cause Mortality - participants at risk for Other (Not Including Serious) Adverse Events
|
0.00%
0/1 • From start of study treatment up to early termination of the study (approximately 22 months)
Study was terminated early. One arm/ group (ARALAST NP 120 mg/kg (Group 2)) did not have any participants randomized to it at the time of the study termination. Therefore there are zero participants at risk. This applies to the following fields, below for the ARALAST NP 120 mg/kg (Group 2) arm/group: - participants at risk for Serious Adverse Events - participants at risk for All-Cause Mortality - participants at risk for Other (Not Including Serious) Adverse Events
|
50.0%
1/2 • Number of events 1 • From start of study treatment up to early termination of the study (approximately 22 months)
Study was terminated early. One arm/ group (ARALAST NP 120 mg/kg (Group 2)) did not have any participants randomized to it at the time of the study termination. Therefore there are zero participants at risk. This applies to the following fields, below for the ARALAST NP 120 mg/kg (Group 2) arm/group: - participants at risk for Serious Adverse Events - participants at risk for All-Cause Mortality - participants at risk for Other (Not Including Serious) Adverse Events
|
|
General disorders
site conditions/ Catheter site rash/ MILD RASH AT THE SITE OF TAPE USED AT IV CANNULA SITE
|
0.00%
0/1 • From start of study treatment up to early termination of the study (approximately 22 months)
Study was terminated early. One arm/ group (ARALAST NP 120 mg/kg (Group 2)) did not have any participants randomized to it at the time of the study termination. Therefore there are zero participants at risk. This applies to the following fields, below for the ARALAST NP 120 mg/kg (Group 2) arm/group: - participants at risk for Serious Adverse Events - participants at risk for All-Cause Mortality - participants at risk for Other (Not Including Serious) Adverse Events
|
—
0/0 • From start of study treatment up to early termination of the study (approximately 22 months)
Study was terminated early. One arm/ group (ARALAST NP 120 mg/kg (Group 2)) did not have any participants randomized to it at the time of the study termination. Therefore there are zero participants at risk. This applies to the following fields, below for the ARALAST NP 120 mg/kg (Group 2) arm/group: - participants at risk for Serious Adverse Events - participants at risk for All-Cause Mortality - participants at risk for Other (Not Including Serious) Adverse Events
|
0.00%
0/1 • From start of study treatment up to early termination of the study (approximately 22 months)
Study was terminated early. One arm/ group (ARALAST NP 120 mg/kg (Group 2)) did not have any participants randomized to it at the time of the study termination. Therefore there are zero participants at risk. This applies to the following fields, below for the ARALAST NP 120 mg/kg (Group 2) arm/group: - participants at risk for Serious Adverse Events - participants at risk for All-Cause Mortality - participants at risk for Other (Not Including Serious) Adverse Events
|
0.00%
0/1 • From start of study treatment up to early termination of the study (approximately 22 months)
Study was terminated early. One arm/ group (ARALAST NP 120 mg/kg (Group 2)) did not have any participants randomized to it at the time of the study termination. Therefore there are zero participants at risk. This applies to the following fields, below for the ARALAST NP 120 mg/kg (Group 2) arm/group: - participants at risk for Serious Adverse Events - participants at risk for All-Cause Mortality - participants at risk for Other (Not Including Serious) Adverse Events
|
50.0%
1/2 • Number of events 1 • From start of study treatment up to early termination of the study (approximately 22 months)
Study was terminated early. One arm/ group (ARALAST NP 120 mg/kg (Group 2)) did not have any participants randomized to it at the time of the study termination. Therefore there are zero participants at risk. This applies to the following fields, below for the ARALAST NP 120 mg/kg (Group 2) arm/group: - participants at risk for Serious Adverse Events - participants at risk for All-Cause Mortality - participants at risk for Other (Not Including Serious) Adverse Events
|
|
Reproductive system and breast disorders
Vaginal haemorrhage/ PER VAGINAL BLEEDING
|
0.00%
0/1 • From start of study treatment up to early termination of the study (approximately 22 months)
Study was terminated early. One arm/ group (ARALAST NP 120 mg/kg (Group 2)) did not have any participants randomized to it at the time of the study termination. Therefore there are zero participants at risk. This applies to the following fields, below for the ARALAST NP 120 mg/kg (Group 2) arm/group: - participants at risk for Serious Adverse Events - participants at risk for All-Cause Mortality - participants at risk for Other (Not Including Serious) Adverse Events
|
—
0/0 • From start of study treatment up to early termination of the study (approximately 22 months)
Study was terminated early. One arm/ group (ARALAST NP 120 mg/kg (Group 2)) did not have any participants randomized to it at the time of the study termination. Therefore there are zero participants at risk. This applies to the following fields, below for the ARALAST NP 120 mg/kg (Group 2) arm/group: - participants at risk for Serious Adverse Events - participants at risk for All-Cause Mortality - participants at risk for Other (Not Including Serious) Adverse Events
|
0.00%
0/1 • From start of study treatment up to early termination of the study (approximately 22 months)
Study was terminated early. One arm/ group (ARALAST NP 120 mg/kg (Group 2)) did not have any participants randomized to it at the time of the study termination. Therefore there are zero participants at risk. This applies to the following fields, below for the ARALAST NP 120 mg/kg (Group 2) arm/group: - participants at risk for Serious Adverse Events - participants at risk for All-Cause Mortality - participants at risk for Other (Not Including Serious) Adverse Events
|
0.00%
0/1 • From start of study treatment up to early termination of the study (approximately 22 months)
Study was terminated early. One arm/ group (ARALAST NP 120 mg/kg (Group 2)) did not have any participants randomized to it at the time of the study termination. Therefore there are zero participants at risk. This applies to the following fields, below for the ARALAST NP 120 mg/kg (Group 2) arm/group: - participants at risk for Serious Adverse Events - participants at risk for All-Cause Mortality - participants at risk for Other (Not Including Serious) Adverse Events
|
50.0%
1/2 • Number of events 3 • From start of study treatment up to early termination of the study (approximately 22 months)
Study was terminated early. One arm/ group (ARALAST NP 120 mg/kg (Group 2)) did not have any participants randomized to it at the time of the study termination. Therefore there are zero participants at risk. This applies to the following fields, below for the ARALAST NP 120 mg/kg (Group 2) arm/group: - participants at risk for Serious Adverse Events - participants at risk for All-Cause Mortality - participants at risk for Other (Not Including Serious) Adverse Events
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease/ COPD EXACERBATION
|
0.00%
0/1 • From start of study treatment up to early termination of the study (approximately 22 months)
Study was terminated early. One arm/ group (ARALAST NP 120 mg/kg (Group 2)) did not have any participants randomized to it at the time of the study termination. Therefore there are zero participants at risk. This applies to the following fields, below for the ARALAST NP 120 mg/kg (Group 2) arm/group: - participants at risk for Serious Adverse Events - participants at risk for All-Cause Mortality - participants at risk for Other (Not Including Serious) Adverse Events
|
—
0/0 • From start of study treatment up to early termination of the study (approximately 22 months)
Study was terminated early. One arm/ group (ARALAST NP 120 mg/kg (Group 2)) did not have any participants randomized to it at the time of the study termination. Therefore there are zero participants at risk. This applies to the following fields, below for the ARALAST NP 120 mg/kg (Group 2) arm/group: - participants at risk for Serious Adverse Events - participants at risk for All-Cause Mortality - participants at risk for Other (Not Including Serious) Adverse Events
|
0.00%
0/1 • From start of study treatment up to early termination of the study (approximately 22 months)
Study was terminated early. One arm/ group (ARALAST NP 120 mg/kg (Group 2)) did not have any participants randomized to it at the time of the study termination. Therefore there are zero participants at risk. This applies to the following fields, below for the ARALAST NP 120 mg/kg (Group 2) arm/group: - participants at risk for Serious Adverse Events - participants at risk for All-Cause Mortality - participants at risk for Other (Not Including Serious) Adverse Events
|
0.00%
0/1 • From start of study treatment up to early termination of the study (approximately 22 months)
Study was terminated early. One arm/ group (ARALAST NP 120 mg/kg (Group 2)) did not have any participants randomized to it at the time of the study termination. Therefore there are zero participants at risk. This applies to the following fields, below for the ARALAST NP 120 mg/kg (Group 2) arm/group: - participants at risk for Serious Adverse Events - participants at risk for All-Cause Mortality - participants at risk for Other (Not Including Serious) Adverse Events
|
50.0%
1/2 • Number of events 1 • From start of study treatment up to early termination of the study (approximately 22 months)
Study was terminated early. One arm/ group (ARALAST NP 120 mg/kg (Group 2)) did not have any participants randomized to it at the time of the study termination. Therefore there are zero participants at risk. This applies to the following fields, below for the ARALAST NP 120 mg/kg (Group 2) arm/group: - participants at risk for Serious Adverse Events - participants at risk for All-Cause Mortality - participants at risk for Other (Not Including Serious) Adverse Events
|
|
Gastrointestinal disorders
DIARRHOEA
|
100.0%
1/1 • Number of events 1 • From start of study treatment up to early termination of the study (approximately 22 months)
Study was terminated early. One arm/ group (ARALAST NP 120 mg/kg (Group 2)) did not have any participants randomized to it at the time of the study termination. Therefore there are zero participants at risk. This applies to the following fields, below for the ARALAST NP 120 mg/kg (Group 2) arm/group: - participants at risk for Serious Adverse Events - participants at risk for All-Cause Mortality - participants at risk for Other (Not Including Serious) Adverse Events
|
—
0/0 • From start of study treatment up to early termination of the study (approximately 22 months)
Study was terminated early. One arm/ group (ARALAST NP 120 mg/kg (Group 2)) did not have any participants randomized to it at the time of the study termination. Therefore there are zero participants at risk. This applies to the following fields, below for the ARALAST NP 120 mg/kg (Group 2) arm/group: - participants at risk for Serious Adverse Events - participants at risk for All-Cause Mortality - participants at risk for Other (Not Including Serious) Adverse Events
|
0.00%
0/1 • From start of study treatment up to early termination of the study (approximately 22 months)
Study was terminated early. One arm/ group (ARALAST NP 120 mg/kg (Group 2)) did not have any participants randomized to it at the time of the study termination. Therefore there are zero participants at risk. This applies to the following fields, below for the ARALAST NP 120 mg/kg (Group 2) arm/group: - participants at risk for Serious Adverse Events - participants at risk for All-Cause Mortality - participants at risk for Other (Not Including Serious) Adverse Events
|
0.00%
0/1 • From start of study treatment up to early termination of the study (approximately 22 months)
Study was terminated early. One arm/ group (ARALAST NP 120 mg/kg (Group 2)) did not have any participants randomized to it at the time of the study termination. Therefore there are zero participants at risk. This applies to the following fields, below for the ARALAST NP 120 mg/kg (Group 2) arm/group: - participants at risk for Serious Adverse Events - participants at risk for All-Cause Mortality - participants at risk for Other (Not Including Serious) Adverse Events
|
0.00%
0/2 • From start of study treatment up to early termination of the study (approximately 22 months)
Study was terminated early. One arm/ group (ARALAST NP 120 mg/kg (Group 2)) did not have any participants randomized to it at the time of the study termination. Therefore there are zero participants at risk. This applies to the following fields, below for the ARALAST NP 120 mg/kg (Group 2) arm/group: - participants at risk for Serious Adverse Events - participants at risk for All-Cause Mortality - participants at risk for Other (Not Including Serious) Adverse Events
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
- Publication restrictions are in place
Restriction type: OTHER