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| Name | Class |
|---|---|
| Grifols Biologicals, LLC | INDUSTRY |
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This is a pilot, phase 2, prospective, open-label, single-arm study to evaluate disease progression, forced vital capacity, and the safety and tolerability of plasma exchange (PE) using Albutein® 5% in participants with amyotrophic lateral sclerosis (ALS).
This is a phase 2, prospective, open-label, single-arm pilot study to evaluate the efficacy and safety of PE with Albutein® 5% in participants with ALS. The planned enrollment is 10 participants who have a definite, possible, or probable diagnosis of ALS, according to the revised El Escorial criteria. Enrolled participants will be treated with PE using Albutein 5% as a replacement solution during an Intensive Treatment Phase (2 PEs per week over 3 weeks) followed by a Maintenance Treatment Phase (weekly PE for 21 weeks) for a total treatment duration of 6 months. A 6-month follow up will begin after the last PE.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Albutein 5% | Experimental | Plasma exchanges (PEs) with albutein 5% as a replacement solution during an intensive treatment phase of two PEs per week over 3 weeks followed by maintenance treatment phase of weekly PE for 21 weeks. The dose of albutein 5% for replacement following plasma removal was calculated based on gender, weight, and the hematocrit of the participant. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Albutein 5% | Biological | Albutein is manufactured from human plasma. The dose of Albutein 5% for replacement following plasma removal will be calculated based on gender, weight, and the hematocrit of the participant. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) Score | The ALSFRS-R includes 12 questions to assess the self-sufficiency of participants in 3 sub-domains: bulbar function (questions 1-3), fine and gross motor function (questions 4-9), and respiratory function (question 10-12). Aspects of nourishment, personal care, personal autonomy, and communication were also evaluated. Each task was graded on a five-point scale from 0 (incapable) to 4 (normal ability), with total score range from 0 (worst) to 48 (best). A positive change from Baseline indicates improvement. | Baseline (Week 0), Weeks 4, 12, 25, 36, and 48 |
| Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) | The FVC measured the volume of air that can forcibly be exhaled through a spirometer after a full inspiration. It was expressed in a percentage of actual FVC over the expected FVC result in the general population, calculated as: Percent predicted FVC (in %) = [(observed FVC in liters)/(predicted FVC in liters)]*100. | Baseline (Week 0), Weeks 4, 12, 25, 36, and 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Cognitive Function as Assessed by Behaviour Status Sub-scale Score of the Amyotrophic Lateral Sclerosis - Cognitive Behavioural Screen (ALS-CBS) Test | ALS-CBS test is composed of two sections: the cognitive screening section and behavioural changes section. The section of behavioural changes consists of behaviour status and symptom status sub-scales. Behaviour status sub-scale consists of a questionnaire with 15 items assessed by the caretaker. Each item was scored on a scale ranging from 0 (worst) to 3 (best) yielding a total 0= large changes to 45= no changes. A positive change from Baseline indicates improvement. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of PE Sessions Associated With at Least One Adverse Reaction (AR) | During or within 72 hours after the completion of the product infusion | |
| Percentage of PE Sessions Associated With at Least One Adverse Event (AE), Irrespective of Causality | During or within 72 hours after the completion of the product infusion |
Inclusion Criteria:
Exclusion Criteria:
Subjects with pre-existing clinically significant lung disease not attributable to ALS
Subjects diagnosed with other neurodegenerative diseases or diseases associated with other motor neuron dysfunction
Participation in another investigational product study within one month prior to screening
Females who are pregnant, breastfeeding, or, if of child-bearing potential, unwilling to practice a highly effective method of contraception (oral, injectable or implanted hormonal methods of contraception, placement of an intrauterine device or intrauterine system, condom or occlusive cap with spermicidal foam/ gel/ film/ cream/ suppository, male sterilization, or true abstinence) throughout the study
Difficult or problematic peripheral vein access and inability to implant a central catheter which would make continuous Plasma exchange (PE) not feasible as per the visit protocol
Contraindication to undergo PE or subject has abnormal coagulation parameters at the discretion of the Outpatient Apheresis Unit team, including but not limited to:
History of anaphylaxis or severe systemic response to any plasma-derived albumin preparation, component of Albutein® 5%, or other blood product(s)
Subjects unable to interrupt treatment with acetylsalicylic acid, other oral antiplatelet, or anticoagulant
Renal dysfunction by elevated creatinine concentration >2 milligram per deciliter (mg/dL)
Presence of heart disease that contraindicates PE treatment, including ischemic cardiopathy and congestive heart failure
Presence of prior behavioural disorders requiring pharmacological intervention with less than 3 months of stable treatment
Mentally challenged subject who cannot give independent informed consent
Any condition that would complicate compliance with the study protocol (i.e., illness with the expectation of less than one year survival, abuse of drugs or alcohol, etc.)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
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Participants with diagnosis of amyotrophic lateral sclerosis (ALS) were enrolled to receive plasma exchanges with albutein 5% as a replacement solution as per the protocol defined schedule for 24 weeks.
Participants took part in this study at a single study center in the Unites States from 29 August 2016 to 15 August 2019.
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| ID | Title | Description |
|---|---|---|
| FG000 | Albutein 5% | Plasma exchanges (PEs) with albutein 5% as a replacement solution during an intensive treatment phase of two PEs per week over 3 weeks followed by maintenance treatment phase of weekly PE for 21 weeks. The dose of albutein 5% for replacement following plasma removal was calculated based on gender, weight, and the hematocrit of the participant. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Safety population included all participants who received any amount of the study drug.
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| ID | Title | Description |
|---|---|---|
| BG000 | Albutein 5% | PEs with albutein 5% as a replacement solution during an intensive treatment phase of two PEs per week over 3 weeks followed by maintenance treatment phase of weekly PE for 21 weeks. The dose of albutein 5% for replacement following plasma removal was calculated based on gender, weight, and the hematocrit of the participant. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) Score | The ALSFRS-R includes 12 questions to assess the self-sufficiency of participants in 3 sub-domains: bulbar function (questions 1-3), fine and gross motor function (questions 4-9), and respiratory function (question 10-12). Aspects of nourishment, personal care, personal autonomy, and communication were also evaluated. Each task was graded on a five-point scale from 0 (incapable) to 4 (normal ability), with total score range from 0 (worst) to 48 (best). A positive change from Baseline indicates improvement. | Evaluable Population included all participants who received at least one PE treatment with albutein 5% and also had at least one baseline determination and a measurement of a primary efficacy variable at a subsequent visit. Number analyzed is the number of participants with data available for analyses at the given time point. | Posted | Mean | Standard Deviation | units on scale | Baseline (Week 0), Weeks 4, 12, 25, 36, and 48 |
|
From the start of study treatment until end of study (Up to Week 48)
Safety population included all participants who received any amount of the study drug.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Albutein 5% | Plasma exchanges (PEs) with Albutein 5% as a replacement solution during an intensive treatment phase of two PEs per week over 3 weeks followed by maintenance treatment phase of weekly PE for 21 weeks. The dose of Albutein 5% for replacement following plasma removal was calculated based on gender, weight, and the hematocrit of the participant. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Jugular vein occlusion | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Conjunctival haemorrhage | Eye disorders | MedDRA (17.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Woodward | Grifols Bioscience Industrial Group | +34 938008784 | michael.woodward@grifols.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 5, 2016 | Apr 7, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 29, 2019 | Apr 7, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000690 | Amyotrophic Lateral Sclerosis |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D016472 | Motor Neuron Disease |
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| ID | Term |
|---|---|
| D000418 | Albumins |
| D012996 | Solutions |
| D010477 | Perfusion |
| D010951 | Plasma Exchange |
| ID | Term |
|---|---|
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D004364 | Pharmaceutical Preparations |
| D008919 | Investigative Techniques |
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|
| Plasma Exchange | Procedure | Plasma Exchange will be performed using albutein 5% as the replacement solution. |
|
| Baseline (Week 0), Weeks 25, and 48 |
| Change From Baseline in Cognitive Function as Assessed by Symptom Status Sub-scale Score of the Amyotrophic Lateral Sclerosis - Cognitive Behavioral Screen (ALS-CBS) Test | ALS-CBS test is composed of two sections: cognitive screening section and behavioural changes section. The section of behavioural changes consists of behaviour status and symptom status sub-scales. Cognitive function assessed by symptom status sub-scale is reported, which consists of 4 additional questions related to current behavioural symptoms (depression, anxiety, fatigue, and emotional liability). Each question was scored as 0= the presence of symptoms and 1= no current symptoms, giving a total subscale score between 0 and 4. A positive change from Baseline indicates improvement. | Baseline (Week 0), Weeks 25, and 48 |
| Change From Baseline in Cognitive Function as Assessed by Cognitive Screening Section Score of the Amyotrophic Lateral Sclerosis - Cognitive Behavioral Screen (ALS-CBS) Test | ALS-CBS test is composed of two sections: cognitive screening section and behavioural changes section. Cognitive function is evaluated using cognitive screening section which consists of: attention (complex orders, mental sums, language, and eye movement); concentration (inversion of numeric series); follow-up and monitoring (reverse sequences, alphabet, number and letter sequencing); and initiation and recovery (nomination). The individual items were scored from 0-5, and the total score ranges from 0-20, where 0= cognitive impairment, 20= no apparent cognitive impairment. A positive change from baseline indicates improvement. | Baseline (Week 0), Weeks 25, and 48 |
| Change From Baseline in the Motor Evoked Potential in Thenar and Hypothenar Eminence and Anterior Tibialis Muscle Determined by Electromyography (EMG) | Surface EMG was performed to record motor evoked potential in the distal muscles of the upper limbs (thenar and hypothenar eminence) and dorsiflexor muscles of the lower limbs (anterior tibialis) after electrical stimulation on the median, ulnar, and external popliteal sciatic nerve. The data for motor evoked potential (in millivolt [mv]) is reported for thenar muscles of both upper limbs and hypothenar muscle of the upper right limb and anterior tibialis of the both lower limbs. | Baseline (Week 0), Weeks 4, 12, 25, 36, and 48 |
| Evaluation of Quality of Life Using the Amyotrophic Lateral Sclerosis Assessment Questionnaire 40 (ALSA-Q40) Test Dimension Score | The ALS questionnaire consists of 40 items grouped into 5 representative dimensions associated with quality of life. The first four dimensions were: physical mobility (questions 1-10), activities of daily living (questions 11- 20), food and drink (questions 21-23), communication (questions 24-30) and emotional function (questions 31-40), refer to deficits and subsequent disabilities as a result of the disease. The fifth scale (emotional functioning) reflects how the participant is facing his/her physical deterioration emotionally. Each item is scored from 0 to 4 according to a gradation of symptom onset frequency (never, rarely, sometimes, often, always). From raw scores, an index from 0 to 100 is obtained for each dimension, which make comparisons with the other dimensions possible as well as a straightforward interpretation of the results (0 = better state of health as measured by the questionnaire;100 = poorer state of health). A negative change from Baseline indicates improvement. | Weeks 25 and 48 |
| Change From Baseline in Plasma Human Apolipoprotein Levels | The levels of human Apolipoprotein (ApoE) in plasma were measured by enzyme-linked immunosorbent assay (ELISA). | Baseline (Week 0), before and after PE procedure at Weeks 4, 12, 24, and before PE for Weeks 36 and 48 |
| Change From Baseline in Plasma Cytokine Panel Levels | The plasma cytokine panel includes: transforming growth factor (TGF) beta1, TGF beta2, TGF beta3, interferon (IFN) gamma, interleukins (IL)-1beta, IL-1Ra, IL-6, IL-8, IL-10, IL-12 p70, IL-17A, IFN-γ-inducible protein (IP)-10, human monocyte chemoattractant protein (MCP)-1, macrophage-derived chemokine (MDC), macrophage inflammatory protein (MIP)-1-alpha, MIP-1-beta, tumor necrosis factor (TNF)-alpha, soluble cluster of differentiation (CD) 40 ligand (sCD40L), fractalkine. The level of each of these cytokines are reported as categories. Only categories with values above the level of detection are reported. | Baseline (Week 0), before and after PE procedure at Weeks 4, 12, 24, and before PE for Weeks 36 and 48 |
| Change From Baseline in Cerebrospinal Fluid (CSF) Human Apolipoprotein Levels | The levels of human Apolipoprotein (ApoE) in CSF were measured by enzyme-linked immunosorbent assay (ELISA). | Baseline (Week 0), Weeks 12, and 25 |
| Change From Baseline in CSF Cytokine Panel Levels | The CSF cytokine panel includes: TGF beta1, TGF beta2, TGF beta3, IFN gamma, IL-1beta, IL-1Ra, IL-6, IL-8, IL-10, IL-12 p70, IL-17A, IP-10, MCP-1, MDC, MIP-1 alpha, MIP-1 beta, TNF alpha, sCD40L, fractalkine. The level of each of these cytokines are reported as categories. Only categories with values above the level of detection are reported. | Baseline (Week 0), Weeks 12, and 25 |
| Change From Baseline in Plasma Beta-methylamino-L-alanine (BMAA) Levels | Plasma BMAA levels at baseline and over the course of treatment at each evaluation visit were measured to identify reductions in BMAA levels, which could potentially be correlated with disease progression or a halt in disease progression. Analysis was performed using a Thermo TSQ Quantiva triple-stage quadrupole mass spectrometer. | Baseline (Week 0), before and after PE procedure at Weeks 4, 12, 24, and before PE for Weeks 36 and 48 |
| Change From Cerebrospinal Fluid (CSF) Beta-methylamino-L-alanine (BMAA) Levels | CSF BMAA levels at baseline and over the course of treatment at each evaluation visit were measured to identify reductions in BMAA levels, which could potentially be correlated with disease progression or a halt in disease progression. Analysis was performed using a Thermo TSQ Quantiva triple quadrupole mass spectrometer. | Baseline (Week 0), Weeks 12, and 25 |
| Change From Baseline in Absolute Leukocyte Count | The immune population profile in ALS participants was assessed by flow cytometry following whole blood staining by Western Blot (WB) for the absolute leukocyte count. Absolute leukocyte count (10^3 cells/microliter) was analyzed for neutrophils, lymphocytes, CD14+ monocytes, CD3+CD4+ T cells, CD3+CD8+ T cells, CD19+ B cells and CD56+ natural killer (NK) cells. | Baseline, Weeks 4, 12, and 48 |
| Change From Baseline in Immune Population Profile | The immune population profile includes: Leukocyte panel (neutrophils, lymphocytes, CD14+ monos, CD3+CD4+ T cells, CD3+CD8+ T cells, CD19+ B cells, CD56+ NK cells). Regulatory T cells (Treg panel) (CD4+FoxP3+CD127low/, CD4+FoxP3+CD127low/-CD39+, CD4+FoxP3+CD127low/-CD45RA, CD4+FoxP3+CD127low/-CD152+), Myeloid-Derived Suppressor Cells (MDSC) (panel: CD14+CD15- monocytic MDSCs, CD14+CD15- monocytic MDSCs, CD124+ monocytic MDSCs, CD14-CD15+ granulocytic MDSCs, CD124+ granulocytic MDSCs, CD14-CD15- immature MDSCs, CD124+ immature MDSCs), Monocyte panel (CD14+CD16+, CD14+human leukocyte antigen-D related (HLA-DR)+ CD11b, CD14+HLA-DR+ CD163+, CD14+HLA-DR+ CX3CR1+). Data for each of these were reported as categories. Only categories with values above the level of detection are reported. | Baseline, Weeks 4, 12, and 48 |
| Change From Baseline in Plasma Neurofilament Levels | Levels of neurofilaments: Phosphorylated Neurofilament heavy chain (pNF-H) and Neurofilament light chain (NF-L) were measured by Enzyme-Linked Immunosorbent Assay (ELISA). | Baseline (Week 0), before and after PE procedure at Weeks 4, 12, 24, and before PE for Weeks 36 and 48 |
| Change From Baseline in Cerebrospinal Fluid (CSF) Neurofilament Levels | Levels of neurofilaments: Phosphorylated Neurofilament heavy chain (pNF-H) and Neurofilament light chain (NF-L) were measured by Enzyme-Linked Immunosorbent Assay (ELISA). | Baseline (Week 0), Weeks 12, and 25 |
| Incidence of All AEs | Weeks -2 to 48 |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG000 |
| Albutein 5% |
PEs with albutein 5% as a replacement solution during an intensive treatment phase of two PEs per week over 3 weeks followed by maintenance treatment phase of weekly PE for 21 weeks. The dose of albutein 5% for replacement following plasma removal was calculated based on gender, weight, and the hematocrit of the participant. |
|
|
| Primary | Change From Baseline in Percent Predicted Forced Vital Capacity (FVC) | The FVC measured the volume of air that can forcibly be exhaled through a spirometer after a full inspiration. It was expressed in a percentage of actual FVC over the expected FVC result in the general population, calculated as: Percent predicted FVC (in %) = [(observed FVC in liters)/(predicted FVC in liters)]*100. | Evaluable Population included all participants who received at least one PE treatment with albutein 5% and also had at least one baseline determination and a measurement of a primary efficacy variable at a subsequent visit. Number analyzed is the number of participants with data available for analyses at the given time point. | Posted | Mean | Standard Deviation | percentage of predicted FVC | Baseline (Week 0), Weeks 4, 12, 25, 36, and 48 |
|
|
|
| Secondary | Change From Baseline in Cognitive Function as Assessed by Behaviour Status Sub-scale Score of the Amyotrophic Lateral Sclerosis - Cognitive Behavioural Screen (ALS-CBS) Test | ALS-CBS test is composed of two sections: the cognitive screening section and behavioural changes section. The section of behavioural changes consists of behaviour status and symptom status sub-scales. Behaviour status sub-scale consists of a questionnaire with 15 items assessed by the caretaker. Each item was scored on a scale ranging from 0 (worst) to 3 (best) yielding a total 0= large changes to 45= no changes. A positive change from Baseline indicates improvement. | Evaluable Population included all participants who received at least one PE treatment with albutein 5% and also had at least one baseline determination and measurement of a primary efficacy variable at a subsequent visit. Number analyzed is the number of participants with data available for analyses at the given time point. | Posted | Mean | Standard Deviation | units on a scale | Baseline (Week 0), Weeks 25, and 48 |
|
|
|
| Secondary | Change From Baseline in Cognitive Function as Assessed by Symptom Status Sub-scale Score of the Amyotrophic Lateral Sclerosis - Cognitive Behavioral Screen (ALS-CBS) Test | ALS-CBS test is composed of two sections: cognitive screening section and behavioural changes section. The section of behavioural changes consists of behaviour status and symptom status sub-scales. Cognitive function assessed by symptom status sub-scale is reported, which consists of 4 additional questions related to current behavioural symptoms (depression, anxiety, fatigue, and emotional liability). Each question was scored as 0= the presence of symptoms and 1= no current symptoms, giving a total subscale score between 0 and 4. A positive change from Baseline indicates improvement. | Evaluable Population included all participants who received at least one PE treatment with albutein 5% and also had at least one baseline determination and measurement of a primary efficacy variable at a subsequent visit. Number analyzed is the number of participants with data available for analyses at the given time point. | Posted | Mean | Standard Deviation | units on scale | Baseline (Week 0), Weeks 25, and 48 |
|
|
|
| Secondary | Change From Baseline in Cognitive Function as Assessed by Cognitive Screening Section Score of the Amyotrophic Lateral Sclerosis - Cognitive Behavioral Screen (ALS-CBS) Test | ALS-CBS test is composed of two sections: cognitive screening section and behavioural changes section. Cognitive function is evaluated using cognitive screening section which consists of: attention (complex orders, mental sums, language, and eye movement); concentration (inversion of numeric series); follow-up and monitoring (reverse sequences, alphabet, number and letter sequencing); and initiation and recovery (nomination). The individual items were scored from 0-5, and the total score ranges from 0-20, where 0= cognitive impairment, 20= no apparent cognitive impairment. A positive change from baseline indicates improvement. | Evaluable Population included all participants who received at least one PE treatment with albutein 5% and also had at least one baseline determination and measurement of a primary efficacy variable at a subsequent visit. Number analyzed is the number of participants with data available for analyses at the given time point. | Posted | Mean | Standard Deviation | units on scale | Baseline (Week 0), Weeks 25, and 48 |
|
|
|
| Secondary | Change From Baseline in the Motor Evoked Potential in Thenar and Hypothenar Eminence and Anterior Tibialis Muscle Determined by Electromyography (EMG) | Surface EMG was performed to record motor evoked potential in the distal muscles of the upper limbs (thenar and hypothenar eminence) and dorsiflexor muscles of the lower limbs (anterior tibialis) after electrical stimulation on the median, ulnar, and external popliteal sciatic nerve. The data for motor evoked potential (in millivolt [mv]) is reported for thenar muscles of both upper limbs and hypothenar muscle of the upper right limb and anterior tibialis of the both lower limbs. | Evaluable Population included all participants who received at least one PE treatment with albutein 5% and also had at least one baseline determination and a measurement of a primary efficacy variable at a subsequent visit. Number analyzed is the number of participants with data available for the specific category at the given time point. | Posted | Mean | Standard Deviation | millivolt (mV) | Baseline (Week 0), Weeks 4, 12, 25, 36, and 48 |
|
|
|
| Secondary | Evaluation of Quality of Life Using the Amyotrophic Lateral Sclerosis Assessment Questionnaire 40 (ALSA-Q40) Test Dimension Score | The ALS questionnaire consists of 40 items grouped into 5 representative dimensions associated with quality of life. The first four dimensions were: physical mobility (questions 1-10), activities of daily living (questions 11- 20), food and drink (questions 21-23), communication (questions 24-30) and emotional function (questions 31-40), refer to deficits and subsequent disabilities as a result of the disease. The fifth scale (emotional functioning) reflects how the participant is facing his/her physical deterioration emotionally. Each item is scored from 0 to 4 according to a gradation of symptom onset frequency (never, rarely, sometimes, often, always). From raw scores, an index from 0 to 100 is obtained for each dimension, which make comparisons with the other dimensions possible as well as a straightforward interpretation of the results (0 = better state of health as measured by the questionnaire;100 = poorer state of health). A negative change from Baseline indicates improvement. | Evaluable Population included all participants who received at least one PE treatment with albutein 5% and also had at least one baseline determination and a measurement of a primary efficacy variable at a subsequent visit. Number analyzed is the number of participants with data available for the specific category at the given time point. | Posted | Mean | Standard Deviation | units on a scale | Weeks 25 and 48 |
|
|
|
| Secondary | Change From Baseline in Plasma Human Apolipoprotein Levels | The levels of human Apolipoprotein (ApoE) in plasma were measured by enzyme-linked immunosorbent assay (ELISA). | Evaluable Population included all participants who received at least one PE treatment with albutein 5% and also had at least one baseline determination and measurement of a primary efficacy variable at a subsequent visit. Number analyzed is the number of participants with data available for analyses at the given time point. | Posted | Mean | Standard Deviation | nanogram per milliliter (ng/mL) | Baseline (Week 0), before and after PE procedure at Weeks 4, 12, 24, and before PE for Weeks 36 and 48 |
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|
| Secondary | Change From Baseline in Plasma Cytokine Panel Levels | The plasma cytokine panel includes: transforming growth factor (TGF) beta1, TGF beta2, TGF beta3, interferon (IFN) gamma, interleukins (IL)-1beta, IL-1Ra, IL-6, IL-8, IL-10, IL-12 p70, IL-17A, IFN-γ-inducible protein (IP)-10, human monocyte chemoattractant protein (MCP)-1, macrophage-derived chemokine (MDC), macrophage inflammatory protein (MIP)-1-alpha, MIP-1-beta, tumor necrosis factor (TNF)-alpha, soluble cluster of differentiation (CD) 40 ligand (sCD40L), fractalkine. The level of each of these cytokines are reported as categories. Only categories with values above the level of detection are reported. | Evaluable Population included all participants who received at least one PE treatment with albutein 5% and also had at least one baseline determination and measurement of a primary efficacy variable at a subsequent visit. Number analyzed is the number of participants with detectable values for the analyses of the specific category at the given time point. | Posted | Mean | Standard Deviation | picogram per milliliter (pg/mL) | Baseline (Week 0), before and after PE procedure at Weeks 4, 12, 24, and before PE for Weeks 36 and 48 |
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|
|
| Secondary | Change From Baseline in Cerebrospinal Fluid (CSF) Human Apolipoprotein Levels | The levels of human Apolipoprotein (ApoE) in CSF were measured by enzyme-linked immunosorbent assay (ELISA). | Evaluable Population included all participants who received at least one PE treatment with albutein 5% and also had at least one baseline determination and a measurement of a primary efficacy variable at a subsequent visit. Number analyzed is the number of participants with data available for analyses at the given time point. | Posted | Mean | Standard Deviation | ng/mL | Baseline (Week 0), Weeks 12, and 25 |
|
|
|
| Secondary | Change From Baseline in CSF Cytokine Panel Levels | The CSF cytokine panel includes: TGF beta1, TGF beta2, TGF beta3, IFN gamma, IL-1beta, IL-1Ra, IL-6, IL-8, IL-10, IL-12 p70, IL-17A, IP-10, MCP-1, MDC, MIP-1 alpha, MIP-1 beta, TNF alpha, sCD40L, fractalkine. The level of each of these cytokines are reported as categories. Only categories with values above the level of detection are reported. | Evaluable Population included all participants who received at least one PE treatment with albutein 5% and also had at least one baseline determination and measurement of a primary efficacy variable at a subsequent visit. Number analyzed is the number of participants with detectable values for the analyses of the specific category at the given time point. | Posted | Mean | Standard Deviation | pg/mL | Baseline (Week 0), Weeks 12, and 25 |
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|
|
| Secondary | Change From Baseline in Plasma Beta-methylamino-L-alanine (BMAA) Levels | Plasma BMAA levels at baseline and over the course of treatment at each evaluation visit were measured to identify reductions in BMAA levels, which could potentially be correlated with disease progression or a halt in disease progression. Analysis was performed using a Thermo TSQ Quantiva triple-stage quadrupole mass spectrometer. | Evaluable Population included all participants who received at least one PE treatment with albutein 5% and also had at least one baseline determination and measurement of a primary efficacy variable at a subsequent visit. Number analyzed is the number of participants with data available for analyses at the given time point. | Posted | Mean | Standard Deviation | ng/mL | Baseline (Week 0), before and after PE procedure at Weeks 4, 12, 24, and before PE for Weeks 36 and 48 |
|
|
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| Secondary | Change From Cerebrospinal Fluid (CSF) Beta-methylamino-L-alanine (BMAA) Levels | CSF BMAA levels at baseline and over the course of treatment at each evaluation visit were measured to identify reductions in BMAA levels, which could potentially be correlated with disease progression or a halt in disease progression. Analysis was performed using a Thermo TSQ Quantiva triple quadrupole mass spectrometer. | Evaluable Population included all participants who received at least one PE treatment with albutein 5% and also had at least one baseline determination and measurement of a primary efficacy variable at a subsequent visit. Number analyzed is the number of participants with data available for analyses at the given time point. | Posted | Mean | Standard Deviation | ng/mL | Baseline (Week 0), Weeks 12, and 25 |
|
|
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| Secondary | Change From Baseline in Absolute Leukocyte Count | The immune population profile in ALS participants was assessed by flow cytometry following whole blood staining by Western Blot (WB) for the absolute leukocyte count. Absolute leukocyte count (10^3 cells/microliter) was analyzed for neutrophils, lymphocytes, CD14+ monocytes, CD3+CD4+ T cells, CD3+CD8+ T cells, CD19+ B cells and CD56+ natural killer (NK) cells. | Evaluable Population included all participants who received at least one PE treatment with albutein 5% and also had at least one baseline determination and a measurement of a primary efficacy variable at a subsequent visit. Number analyzed is the number of participants with data available for analyses of the specific category at the given time point. | Posted | Mean | Standard Deviation | 10^3 cells/microliter | Baseline, Weeks 4, 12, and 48 |
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|
|
| Secondary | Change From Baseline in Immune Population Profile | The immune population profile includes: Leukocyte panel (neutrophils, lymphocytes, CD14+ monos, CD3+CD4+ T cells, CD3+CD8+ T cells, CD19+ B cells, CD56+ NK cells). Regulatory T cells (Treg panel) (CD4+FoxP3+CD127low/, CD4+FoxP3+CD127low/-CD39+, CD4+FoxP3+CD127low/-CD45RA, CD4+FoxP3+CD127low/-CD152+), Myeloid-Derived Suppressor Cells (MDSC) (panel: CD14+CD15- monocytic MDSCs, CD14+CD15- monocytic MDSCs, CD124+ monocytic MDSCs, CD14-CD15+ granulocytic MDSCs, CD124+ granulocytic MDSCs, CD14-CD15- immature MDSCs, CD124+ immature MDSCs), Monocyte panel (CD14+CD16+, CD14+human leukocyte antigen-D related (HLA-DR)+ CD11b, CD14+HLA-DR+ CD163+, CD14+HLA-DR+ CX3CR1+). Data for each of these were reported as categories. Only categories with values above the level of detection are reported. | Evaluable Population included all participants who received at least one PE treatment with albutein 5% and also had at least one baseline determination and a measurement of a primary efficacy variable at a subsequent visit. Number analyzed is the number of participants with detectable values for analyses of the specific category at the given time point. | Posted | Mean | Standard Deviation | percentage of CD45+ cells | Baseline, Weeks 4, 12, and 48 |
|
|
|
| Secondary | Change From Baseline in Plasma Neurofilament Levels | Levels of neurofilaments: Phosphorylated Neurofilament heavy chain (pNF-H) and Neurofilament light chain (NF-L) were measured by Enzyme-Linked Immunosorbent Assay (ELISA). | Evaluable Population included all participants who received at least one PE treatment with albutein 5% and also had at least one baseline determination and measurement of a primary efficacy variable at a subsequent visit. Number analyzed is the number of participants with data available for analyses of the specific category at the given time point. | Posted | Mean | Standard Deviation | ng/mL | Baseline (Week 0), before and after PE procedure at Weeks 4, 12, 24, and before PE for Weeks 36 and 48 |
|
|
|
| Secondary | Change From Baseline in Cerebrospinal Fluid (CSF) Neurofilament Levels | Levels of neurofilaments: Phosphorylated Neurofilament heavy chain (pNF-H) and Neurofilament light chain (NF-L) were measured by Enzyme-Linked Immunosorbent Assay (ELISA). | Evaluable Population included all participants who received at least one PE treatment with albutein 5% and also had at least one baseline determination and a measurement of a primary efficacy variable at a subsequent visit. Number analyzed is the number of participants with data available for analyses for the specific category at the given time point. | Posted | Mean | Standard Deviation | ng/mL | Baseline (Week 0), Weeks 12, and 25 |
|
|
|
| Other Pre-specified | Percentage of PE Sessions Associated With at Least One Adverse Reaction (AR) | Not Posted | During or within 72 hours after the completion of the product infusion | Participants |
| Other Pre-specified | Percentage of PE Sessions Associated With at Least One Adverse Event (AE), Irrespective of Causality | Not Posted | During or within 72 hours after the completion of the product infusion | Participants |
| Other Pre-specified | Incidence of All AEs | Not Posted | Weeks -2 to 48 | Participants |
| 1 |
| 12 |
| 2 |
| 12 |
| 10 |
| 12 |
| Myocardial infarction | Cardiac disorders | MedDRA (17.0) | Systematic Assessment |
|
| Eye swelling | Eye disorders | MedDRA (17.0) | Systematic Assessment |
|
| Ocular hyperaemia | Eye disorders | MedDRA (17.0) | Systematic Assessment |
|
| Abdominal distension | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Inguinal hernia | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Retching | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA (17.0) | Systematic Assessment |
|
| Catheter site erythema | General disorders | MedDRA (17.0) | Systematic Assessment |
|
| Catheter site inflammation | General disorders | MedDRA (17.0) | Systematic Assessment |
|
| Catheter site pain | General disorders | MedDRA (17.0) | Systematic Assessment |
|
| Catheter site pruritus | General disorders | MedDRA (17.0) | Systematic Assessment |
|
| Catheter site related reaction | General disorders | MedDRA (17.0) | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA (17.0) | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA (17.0) | Systematic Assessment |
|
| Feeling hot | General disorders | MedDRA (17.0) | Systematic Assessment |
|
| Gait disturbance | General disorders | MedDRA (17.0) | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA (17.0) | Systematic Assessment |
|
| Peripheral swelling | General disorders | MedDRA (17.0) | Systematic Assessment |
|
| Concussion | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
|
| Head injury | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
|
| Post lumbar puncture syndrome | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
|
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
|
| Skin laceration | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
|
| Wound complication | Injury, poisoning and procedural complications | MedDRA (17.0) | Systematic Assessment |
|
| Blood calcium decreased | Investigations | MedDRA (17.0) | Systematic Assessment |
|
| Blood fibrinogen decreased | Investigations | MedDRA (17.0) | Systematic Assessment |
|
| Blood potassium decreased | Investigations | MedDRA (17.0) | Systematic Assessment |
|
| Weight decreased | Investigations | MedDRA (17.0) | Systematic Assessment |
|
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
| Masticatory pain | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
| Muscle disorder | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
| Balance disorder | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
|
| Dysarthria | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
|
| Muscle contractions involuntary | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
|
| Muscular weakness | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
|
| Anxiety | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA (17.0) | Systematic Assessment |
|
| Nocturia | Renal and urinary disorders | MedDRA (17.0) | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (17.0) | Systematic Assessment |
|
| Cold sweat | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
| Livedo reticularis | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
| Scab | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA (17.0) | Systematic Assessment |
|
| Hypotension | Vascular disorders | MedDRA (17.0) | Systematic Assessment |
|
| Venous thrombosis | Vascular disorders | MedDRA (17.0) | Systematic Assessment |
|
Site may publish results from the Study, after providing Sponsor thirty days' notice prior to submitting a manuscript or other materials related to the Study to any outside party. At Sponsors' request, Site will remove any Confidential Information (other than Study results), and Site will upon Sponsors' request, delay publication or presentation for a period of up to one hundred twenty days to allow Sponsor to protect its interests in any Sponsor Inventions.
| D019636 | Neurodegenerative Diseases |
| D057177 | TDP-43 Proteinopathies |
| D009468 | Neuromuscular Diseases |
| D057165 | Proteostasis Deficiencies |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D001803 | Blood Transfusion |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D010956 | Plasmapheresis |
| D001781 | Blood Component Removal |
| D016060 | Sorption Detoxification |
| D005112 | Extracorporeal Circulation |
| D013514 | Surgical Procedures, Operative |
|
| Change at Week 12 |
|
|
| Change at Week 25 |
|
|
| Change at Week 36 |
|
|
| Change at Week 48 |
|
|
|
| Change at Week 48 |
|
|
|
| Change at Week 48 |
|
|
|
| Change at Week 48 |
|
|
|
| Right Tibialis Anterior, Change at Week 12 |
|
|
| Right Tibialis Anterior, Change at Week 25 |
|
|
| Right Tibialis Anterior, Change at Week 36 |
|
|
| Right Tibialis Anterior, Change at Week 48 |
|
|
| Left Tibialis Anterior, Baseline |
|
|
| Left Tibialis Anterior, Change at Week 4 |
|
|
| Left Tibialis Anterior, Change at Week 12 |
|
|
| Left Tibialis Anterior, Change at Week 25 |
|
|
| Left Tibialis Anterior, Change at Week 36 |
|
|
| Left Tibialis Anterior, Change at Week 48 |
|
|
| Right Thenar Eminence, Baseline |
|
|
| Right Thenar Eminence, Change at Week4 |
|
|
| Right Thenar Eminence, Change at Week 12 |
|
|
| Right Thenar Eminence, Change at Week 25 |
|
|
| Right Thenar Eminence, Change at Week 36 |
|
|
| Right Thenar Eminence, Change at Week 48 |
|
|
| Left Thenar Eminence, Baseline |
|
|
| Left Thenar Eminence, Change at Week 4 |
|
|
| Left Thenar Eminence, Change at Week 12 |
|
|
| Left Thenar Eminence, Change at Week 25 |
|
|
| Left Thenar Eminence, Change at Week 36 |
|
|
| Left Thenar Eminence, Change at Week 48 |
|
|
| Right Hypothenar Eminence, Baseline |
|
|
| Right Hypothenar Eminence, Change at Week 4 |
|
|
| Right Hypothenar Eminence, Change at Week 12 |
|
|
| Right Hypothenar Eminence, Change at Week 25 |
|
|
| Right Hypothenar Eminence, Change at Week 36 |
|
|
| Right Hypothenar Eminence, Change at Week 48 |
|
|
|
| ADL/independence Week 25 |
|
|
| ADL/independence Week 48 |
|
|
| Eating and drinking Week 25 |
|
|
| Eating and drinking Week 48 |
|
|
| Communication Week 25 |
|
|
| Communication Week 48 |
|
|
| Emotional functioning Week 25 |
|
|
| Emotional functioning Week 48 |
|
|
|
| After PE, Change at Week 4 |
|
|
| Before PE, Change at Week 12 |
|
|
| After PE, Change at Week 12 |
|
|
| Before PE, Change at Week 24 |
|
|
| After PE, Change at Week 24 |
|
|
| Before PE, Change at Week 36 |
|
|
| Before PE, Change at Week 48 |
|
|
|
| TGF beta1; After PE, Change at Week 4 |
|
|
| TGF beta1; Before PE, Change at Week 12 |
|
|
| TGF beta1; After PE, Change at Week 12 |
|
|
| TGF beta1; Before PE, Change at Week 24 |
|
|
| TGF beta1; After PE, Change at Week 24 |
|
|
| TGF beta1; Before PE, Change at Week 36 |
|
|
| TGF beta1; Before PE, Change at Week 48 |
|
|
| TGF beta2; Baseline |
|
|
| TGF beta2; Before PE, Change at Week 4 |
|
|
| TGF beta2; After PE, Change at Week 4 |
|
|
| TGF beta2; Before PE, Change at Week 12 |
|
|
| TGF beta2; After PE, Change at Week 12 |
|
|
| TGF beta2; Before PE, Change at Week 24 |
|
|
| TGF beta2; After PE, Change at Week 24 |
|
|
| TGF beta2; Before PE, Change at Week 36 |
|
|
| TGF beta2; Before PE, Change at Week 48 |
|
|
| TGF beta3; Baseline |
|
|
| IFN gamma; Baseline |
|
|
| IFN gamma; Before PE, Change at Week 4 |
|
|
| IFN gamma; Before PE, Change at Week 12 |
|
|
| IFN gamma; Before PE, Change at Week 24 |
|
|
| IFN gamma; Before PE, Change at Week 36 |
|
|
| IFN gamma; Before PE, Change at Week 48 |
|
|
| Interleukin (IL)-1beta; Baseline |
|
|
| IL-1Ra; Baseline |
|
|
| IL-1Ra; Before PE, Change at Week 4 |
|
|
| IL-1Ra; After PE, Change at Week 4 |
|
|
| IL-1Ra; Before PE, Change at Week 12 |
|
|
| IL-1Ra; After PE, Change at Week 12 |
|
|
| IL-1Ra; Before PE, Change at Week 24 |
|
|
| IL-1Ra; After PE, Change at Week 24 |
|
|
| IL-1Ra; Before PE, Change at Week 36 |
|
|
| IL-1Ra; Before PE, Change at Week 48 |
|
|
| IL-6; Baseline |
|
|
| IL-6; Before PE, Change at Week 4 |
|
|
| IL-6; After PE, Change at Week 4 |
|
|
| IL-6; Before PE, Change at Week 12 |
|
|
| IL-6; After PE, Change at Week 12 |
|
|
| IL-6; Before PE, Change at Week 24 |
|
|
| IL-6; After PE, Change at Week 24 |
|
|
| IL-6; Before PE, Change at Week 36 |
|
|
| IL-6; Before PE, Change at Week 48 |
|
|
| IL-8; Baseline |
|
|
| IL-8; Before PE, Change at Week 4 |
|
|
| IL-8; After PE, Change at Week 4 |
|
|
| IL-8; Before PE, Change at Week 12 |
|
|
| IL-8; After PE, Change at Week 12 |
|
|
| IL-8; Before PE, Change at Week 24 |
|
|
| IL-8; After PE, Change at Week 24 |
|
|
| IL-8; Before PE, Change at Week 36 |
|
|
| IL-8; Before PE, Change at Week 48 |
|
|
| IL-10; Baseline |
|
|
| IL-10; Before PE, Change at Week 4 |
|
|
| IL-10; After PE, Change at Week 4 |
|
|
| IL-10; Before PE, Change at Week 12 |
|
|
| IL-10; After PE, Change at Week 12 |
|
|
| IL-10; Before PE, Change at Week 24 |
|
|
| IL-10; After PE, Change at Week 24 |
|
|
| IL-10; Before PE, Change at Week 36 |
|
|
| IL-10; Before PE, Change at Week 48 |
|
|
| IL-12 p70; Baseline |
|
|
| IL-12 p70; Before PE, Change at Week 12 |
|
|
| IL-12 p70; Before PE, Change at Week 24 |
|
|
| IL-12 p70; After PE, Change at Week 24 |
|
|
| IL-12 p70; Before PE, Change at Week 36 |
|
|
| IL-12 p70; Before PE, Change at Week 48 |
|
|
| IL-17A; Baseline |
|
|
| IL-17A; Before PE, Change at Week 4 |
|
|
| IL-17A; After PE, Change at Week 4 |
|
|
| IL-17A; Before PE, Change at Week 12 |
|
|
| IL-17A; After PE, Change at Week 12 |
|
|
| IL-17A; Before PE, Change at Week 24 |
|
|
| IL-17A; After PE, Change at Week 24 |
|
|
| IL-17A; Before PE, Change at Week 36 |
|
|
| IL-17A; Before PE, Change at Week 48 |
|
|
| IP-10; Baseline |
|
|
| IP-10; Before PE, Change at Week 4 |
|
|
| IP-10; After PE, Change at Week 4 |
|
|
| IP-10; Before PE, Change at Week 12 |
|
|
| IP-10; After PE, Change at Week 12 |
|
|
| IP-10; Before PE, Change at Week 24 |
|
|
| IP-10; After PE, Change at Week 24 |
|
|
| IP-10; Before PE, Change at Week 36 |
|
|
| IP-10; Before PE, Change at Week 48 |
|
|
| Human Monocyte Chemoattractant Protein-1 (MCP-1); Baseline |
|
|
| MCP-1; Before PE, Change at Week 4 |
|
|
| MCP-1; After PE, Change at Week 4 |
|
|
| MCP-1; Before PE, Change at Week 12 |
|
|
| MCP-1; After PE, Change at Week 12 |
|
|
| MCP-1; Before PE, Change at Week 24 |
|
|
| MCP-1; After PE, Change at Week 24 |
|
|
| MCP-1; Before PE, Change at Week 36 |
|
|
| MCP-1; Before PE, Change at Week 48 |
|
|
| Macrophage-Derived Chemokine (MDC); Baseline |
|
|
| MDC; Before PE, Change at Week 4 |
|
|
| MDC; After PE, Change at Week 4 |
|
|
| MDC; Before PE, Change at Week 12 |
|
|
| MDC; After PE, Change at Week 12 |
|
|
| MDC; Before PE, Change at Week 24 |
|
|
| MDC; After PE, Change at Week 24 |
|
|
| MDC; Before PE, Change at Week 36 |
|
|
| MDC; Before PE, Change at Week 48 |
|
|
| Macrophage Inflammatory Protein (MIP-1) alpha; Baseline |
|
|
| MIP-1 alpha; Before PE, Change at Week 4 |
|
|
| MIP-1 alpha; After PE, Change at Week 4 |
|
|
| MIP-1 alpha; Before PE, Change at Week 12 |
|
|
| MIP-1 alpha; After PE, Change at Week 12 |
|
|
| MIP-1 alpha; Before PE, Change at Week 24 |
|
|
| MIP-1 alpha; After PE, Change at Week 24 |
|
|
| MIP-1 alpha; Before PE, Change at Week 36 |
|
|
| MIP-1 alpha; Before PE, Change at Week 48 |
|
|
| MIP-1 beta; Baseline |
|
|
| MIP-1 beta; Before PE, Change at Week 4 |
|
|
| MIP-1 beta; After PE, Change at Week 4 |
|
|
| MIP-1 beta; Before PE, Change at Week 12 |
|
|
| MIP-1 beta; After PE, Change at Week 12 |
|
|
| MIP-1 beta; Before PE, Change at Week 24 |
|
|
| MIP-1 beta; After PE, Change at Week 24 |
|
|
| MIP-1 beta; Before PE, Change at Week 36 |
|
|
| MIP-1 beta; Before PE, Change at Week 48 |
|
|
| Tumor Necrosis Factor-Alpha (TNF alpha); Baseline |
|
|
| TNF alpha; Before PE, Change at Week 4 |
|
|
| TNF alpha; After PE, Change at Week 4 |
|
|
| TNF alpha; Before PE, Change at Week 12 |
|
|
| TNF alpha; After PE, Change at Week 12 |
|
|
| TNF alpha; Before PE, Change at Week 24 |
|
|
| TNF alpha; After PE, Change at Week 24 |
|
|
| TNF alpha; Before PE, Change at Week 36 |
|
|
| TNF alpha; Before PE, Change at Week 48 |
|
|
| sCD40L; Baseline |
|
|
| sCD40L; Before PE, Change at Week 4 |
|
|
| sCD40L; After PE, Change at Week 4 |
|
|
| sCD40L; Before PE, Change at Week 12 |
|
|
| sCD40L; After PE, Change at Week 12 |
|
|
| sCD40L; Before PE, Change at Week 24 |
|
|
| sCD40L; After PE, Change at Week 24 |
|
|
| sCD40L; Before PE, Change at Week 36 |
|
|
| sCD40L; Before PE, Change at Week 48 |
|
|
| Fractalkine; Baseline |
|
|
| Fractalkine; Before PE, Change at Week 4 |
|
|
| Fractalkine; After PE, Change at Week 4 |
|
|
| Fractalkine; Before PE, Change at Week 12 |
|
|
| Fractalkine; After PE, Change at Week 12 |
|
|
| Fractalkine; Before PE, Change at Week 24 |
|
|
| Fractalkine; After PE, Change at Week 24 |
|
|
| Fractalkine; Before PE, Change at Week 36 |
|
|
| Fractalkine; Before PE, Change at Week 48 |
|
|
|
| Change at Week 25 |
|
|
|
| TGF beta2; Change at Week 25 |
|
|
| IL-1Ra; Baseline |
|
|
| IL-8; Baseline |
|
|
| IL-8; Change at Week 12 |
|
|
| IL-8; Change at Week 25 |
|
|
| IL-12 p70; Baseline |
|
|
| IL-17A; Baseline |
|
|
| IL-17A; Change at Week 12 |
|
|
| IL-17A; Change at Week 25 |
|
|
| IP-10; Baseline |
|
|
| IP-10; Change at Week 12 |
|
|
| IP-10; Change at Week 25 |
|
|
| MCP-1; Baseline |
|
|
| MCP-1; Change at Week 12 |
|
|
| MCP-1; Change at Week 25 |
|
|
| MDC; Baseline |
|
|
| MDC; Change at Week 12 |
|
|
| MIP-1 beta; Baseline |
|
|
| MIP-1 beta; Change at Week 12 |
|
|
| MIP-1 beta; Change at Week 25 |
|
|
| TNF alpha; Baseline |
|
|
| TNF alpha; Change at Week 12 |
|
|
| TNF alpha; Change at Week 25 |
|
|
| sCD40L; Baseline |
|
|
| sCD40L; Change at Week 12 |
|
|
| sCD40L; Change at Week 25 |
|
|
| Fractalkine; Baseline |
|
|
| Fractalkine; Change at Week 12 |
|
|
| Fractalkine; Change at Week 25 |
|
|
|
| Change at Week 12 |
|
|
| Change at Week 24 |
|
|
| Change at Week 25 |
|
|
| Change at Week 48 |
|
|
|
| Change at Week 25 |
|
|
|
| Absolute leukocyte count neutrophils, Change at Week 12 |
|
|
| Absolute leukocyte count neutrophils, Change at Week 48 |
|
|
| Absolute leukocyte count lymphocytes, Baseline |
|
|
| Absolute leukocyte count lymphocytes, Change at Week 4 |
|
|
| Absolute leukocyte count lymphocytes, Change at Week 12 |
|
|
| Absolute leukocyte count lymphocytes, Change at Week 48 |
|
|
| Absolute leukocyte count CD14+ monocytes, Baseline |
|
|
| Absolute leukocyte count CD14+ monocytes, Change at Week 4 |
|
|
| Absolute leukocyte count CD14+ monocytes, Change at Week 12 |
|
|
| Absolute leukocyte count CD14+ monocytes, Change at Week 48 |
|
|
| Absolute leukocyte count CD3+CD4+ T cells, Baseline |
|
|
| Absolute leukocyte count CD3+CD4+ T cells, Change at Week 4 |
|
|
| Absolute leukocyte count CD3+CD4+ T cells, Change at Week12 |
|
|
| Absolute leukocyte count CD3+CD4+ T cells, Change at Week 48 |
|
|
| Absolute leukocyte count CD3+CD8+ T cells, Baseline |
|
|
| Absolute leukocyte count CD3+CD8+ T cells, Change at Week 4 |
|
|
| Absolute leukocyte count CD3+CD8+ T cells, Change at Week 12 |
|
|
| Absolute leukocyte count CD3+CD8+ T cells, Change at Week 48 |
|
|
| Absolute leukocyte count CD19+ B cells, Baseline |
|
|
| Absolute leukocyte count CD19+ B cells, Change at Week 4 |
|
|
| Absolute leukocyte count CD19+ B cells, Change at Week 12 |
|
|
| Absolute leukocyte count CD19+ B cells, Change at Week 48 |
|
|
| Absolute leukocyte count CD56+ NK cells, Baseline |
|
|
| Absolute leukocyte count CD56+ NK cells Change at Week 4 |
|
|
| Absolute leukocyte count CD56+ NK cells, Change at Week 12 |
|
|
| Absolute leukocyte count CD56+ NK cells, Change at Week 48 |
|
|
|
| Leukocyte panel: neutrophils; Change at Week 12 |
|
|
| Leukocyte panel: neutrophils; Change at Week 48 |
|
|
| Leukocyte panel: lymphocytes; Baseline |
|
|
| Leukocyte panel: lymphocytes; Change at Week 4 |
|
|
| Leukocyte panel: lymphocytes; Change at Week 12 |
|
|
| Leukocyte panel: lymphocytes; Change at Week 48 |
|
|
| Leukocyte panel: CD14+ monos; Baseline |
|
|
| Leukocyte panel: CD14+ monos; Change at Week 4 |
|
|
| Leukocyte panel: CD14+ monos; Change at Week 12 |
|
|
| Leukocyte panel: CD14+ monos; Change at Week 48 |
|
|
| Leukocyte panel: CD3+CD4+ T cells; Baseline |
|
|
| Leukocyte panel: CD3+CD4+ T cells; Change at Week 4 |
|
|
| Leukocyte panel: CD3+CD4+ T cells; Change at Week 12 |
|
|
| Leukocyte panel: CD3+CD4+ T cells; Change at Week 48 |
|
|
| Leukocyte panel: CD3+CD8+ T cells; Baseline |
|
|
| Leukocyte panel: CD3+CD8+ T cells; Change at Week 4 |
|
|
| Leukocyte panel: CD3+CD8+ T cells; Change at Week 12 |
|
|
| Leukocyte panel: CD3+CD8+ T cells; Change at Week 48 |
|
|
| Leukocyte panel: CD19+ B cells; Baseline |
|
|
| Leukocyte panel: CD19+ B cells; Change at Week 4 |
|
|
| Leukocyte panel: CD19+ B cells; Change at Week 12 |
|
|
| Leukocyte panel: CD19+ B cells; Change at Week 48 |
|
|
| Leukocyte panel: CD56+ NK cells; Baseline |
|
|
| Leukocyte panel: CD56+ NK cells; Change at Week 4 |
|
|
| Leukocyte panel: CD56+ NK cells; Change at Week 12 |
|
|
| Leukocyte panel: CD56+ NK cells; Change at Week 48 |
|
|
| Regulatory T cells (Treg panel): CD4+FoxP3+CD127low/-; Baseline |
|
|
| Treg panel: CD4+FoxP3+CD127low/-; Change at Week 4 |
|
|
| Treg panel: CD4+FoxP3+CD127low/-; Change at Week 12 |
|
|
| Treg panel: CD4+FoxP3+CD127low/-; Change at Week 48 |
|
|
| Treg panel: CD4+FoxP3+CD127low/-CD39+; Baseline |
|
|
| Treg panel: CD4+FoxP3+CD127low/-CD39+; Change at Week 4 |
|
|
| Treg panel: CD4+FoxP3+CD127low/-CD39+; Change at Week 12 |
|
|
| Treg panel: CD4+FoxP3+CD127low/-CD39+; Change at Week 48 |
|
|
| Treg panel: CD4+FoxP3+CD127low/-CD45RA; Baseline |
|
|
| Treg panel: CD4+FoxP3+CD127low/-CD45RA; Change at Week 4 |
|
|
| Treg panel: CD4+FoxP3+CD127low/-CD45RA; Change at Week 12 |
|
|
| Treg panel: CD4+FoxP3+CD127low/-CD45RA; Change at Week 48 |
|
|
| Treg panel: CD4+FoxP3+CD127low/-CD152+; Baseline |
|
|
| Treg panel: CD4+FoxP3+CD127low/-CD152+; Change at Week 4 |
|
|
| Treg panel: CD4+FoxP3+CD127low/-CD152+; Change at Week 12 |
|
|
| Treg panel: CD4+FoxP3+CD127low/-CD152+; Change at Week 48 |
|
|
| Myeloid-Derived Suppressor Cells (MDSC) panel: CD14+CD15- monocytic MDSCs; Baseline |
|
|
| Myeloid-Derived Suppressor Cells (MDSC) panel: CD14+CD15- monocytic MDSCs; Change at Week 4 |
|
|
| Myeloid-Derived Suppressor Cells (MDSC) panel: CD14+CD15- monocytic MDSCs; Change at Week 12 |
|
|
| Myeloid-Derived Suppressor Cells (MDSC) panel: CD14+CD15- monocytic MDSCs; Change at Week 48 |
|
|
| MDSC panel: CD124+ monocytic MDSCs; Baseline |
|
|
| MDSC panel: CD124+ monocytic MDSCs; Change at Week 4 |
|
|
| MDSC panel: CD124+ monocytic MDSCs; Change at Week 12 |
|
|
| MDSC panel: CD124+ monocytic MDSCs; Change at Week 48 |
|
|
| MDSC panel: CD14-CD15+ granulocytic MDSCs; Baseline |
|
|
| MDSC panel: CD14-CD15+ granulocytic MDSCs; Change at Week 4 |
|
|
| MDSC panel: CD14-CD15+ granulocytic MDSCs; Change at Week 12 |
|
|
| MDSC panel: CD14-CD15+ granulocytic MDSCs; Change at Week 48 |
|
|
| MDSC panel: CD124+ granulocytic MDSCs; Baseline |
|
|
| MDSC panel: CD124+ granulocytic MDSCs; Change at Week 4 |
|
|
| MDSC panel: CD124+ granulocytic MDSCs; Change at Week 12 |
|
|
| MDSC panel: CD124+ granulocytic MDSCs; Change at Week 48 |
|
|
| MDSC panel: CD14-CD15- immature MDSCs; Baseline |
|
|
| MDSC panel: CD14-CD15- immature MDSCs; Change at Week 4 |
|
|
| MDSC panel: CD14-CD15- immature MDSCs; Change at Week 12 |
|
|
| MDSC panel: CD14-CD15- immature MDSCs; Change at Week 48 |
|
|
| MDSC panel: CD124+ immature MDSCs; Baseline |
|
|
| MDSC panel: CD124+ immature MDSCs; Change at Week 4 |
|
|
| Monocyte panel: CD14+CD16+; Baseline |
|
|
| Monocyte panel: CD14+CD16+; Change at Week 4 |
|
|
| Monocyte panel: CD14+CD16+; Change at Week 12 |
|
|
| Monocyte panel: CD14+CD16+; Change at Week 48 |
|
|
| Monocyte panel: CD14+CD16-; Baseline |
|
|
| Monocyte panel: CD14+CD16-; Change at Week 4 |
|
|
| Monocyte panel: CD14+CD16-; Change at Week 12 |
|
|
| Monocyte panel: CD14+CD16-; Change at Week 48 |
|
|
| Monocyte panel: CD14+HLA-DR+ CD11b+; Baseline |
|
|
| Monocyte panel: CD14+HLA-DR+ CD11b+; Change at Week 4 |
|
|
| Monocyte panel: CD14+HLA-DR+ CD11b+; Change at Week 12 |
|
|
| Monocyte panel: CD14+HLA-DR+ CD11b+; Change at Week 48 |
|
|
| Monocyte panel: CD14+HLA-DR+ CD163+; Baseline |
|
|
| Monocyte panel: CD14+HLA-DR+ CD163+; Change at Week 4 |
|
|
| Monocyte panel: CD14+HLA-DR+ CD163+; Change at Week 12 |
|
|
| Monocyte panel: CD14+HLA-DR+ CD163+; Change at Week 48 |
|
|
| Monocyte panel: CD14+HLA-DR+ CX3CR1+; Baseline |
|
|
| Monocyte panel: CD14+HLA-DR+ CX3CR1+; Change at Week 4 |
|
|
| Monocyte panel: CD14+HLA-DR+ CX3CR1+; Change at Week 12 |
|
|
| Monocyte panel: CD14+HLA-DR+ CX3CR1+; Change at Week 48 |
|
|
|
| pNF-heavy, After PE Change at Week 4 |
|
|
| pNF-heavy, Before PE Change at Week 12 |
|
|
| pNF-heavy, After PE Change at Week 12 |
|
|
| pNF-heavy, Before PE Change at Week 24 |
|
|
| pNF-heavy, After PE Change at Week 24 |
|
|
| pNF-heavy, Before PE Change at Week 36 |
|
|
| pNF-heavy, Before PE Change at Week 48 |
|
|
| NF-light, Baseline |
|
|
| NF-light, Before PE Change at Week 4 |
|
|
| NF-light, After PE Change at Week 4 |
|
|
| NF-light, Before PE Change at Week 12 |
|
|
| NF-light, After PE Change at Week 12 |
|
|
| NF-light, Before PE Change at Week 24 |
|
|
| NF-light, After PE Change at Week 24 |
|
|
| NF-light, Before PE Change at Week 36 |
|
|
| NF-light, Before PE Change at Week 48 |
|
|
|
| pNF-heavy, Change at Week 25 |
|
|
| NF-light, Baseline |
|
|
| NF-light, Change at Week 12 |
|
|
| NF-light, Change at Week 25 |
|
|