Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Defibrotide is an anti-inflammatory and anti-coagulatory agent approved for treatment of veno-occlusive disease. Although it has been in clinical use for almost 30 years, the exact mechanism of action has never been fully elucidated. Thus, the effects of defibrotide will be investigated in the human endotoxemia model in order to gather further information on its actions.
Defibrotide (DF) is a highly complex polydisperse mixture of single-stranded phosphodiester oligodeoxyribonucleotides derived from the controlled depolymerization of porcine intestinal mucosal DNA. The entire mode of action remains unknown. Its actions may be summarized to pro-fibrinolytic, anti-inflammatory and anti-coagulatory actions. To better define the mechanisms of Defibrotide the effects of the substance will be investigated in the well-established endotoxemia model. Sixteen healthy volunteers will be randomized to receive LPS±defibrotide/placebo and four subjects will be randomized to receive Placebo± defibrotide/placebo in a single center, randomized, double blind, placebo controlled, two-way crossover trial. Immediately after a 2h infusion of 6,25mg/kg bodyweight defibrotide or placebo a LPS bolus of 2ng/kg bodyweight will be infused. Analyses will be performed by blood sampling at pre-defined time-points.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Defibrotide/LPS | Active Comparator | 2ng/kg lipopolysaccharide period I: 6.25mg/kg bodyweight defibrotide or placebo (0.9% sodium chloride) period II: vice versa 16 healthy volunteers will receive 2ng/kg bodyweight LPS plus Defibrotide or Placebo 4 healthy volunteers will receive 0.9% saline (NO LPS) plus Defibrotide or Placebo |
|
| Placebo/LPS | Placebo Comparator | 2ng/kg lipopolysaccharide period I: 6.25mg/kg bodyweight defibrotide or placebo (0.9% sodium chloride) period II: vice versa 16 healthy volunteers will receive 2ng/kg bodyweight LPS plus Defibrotide or Placebo 4 healthy volunteers will receive 0.9% saline (NO LPS) plus Defibrotide or Placebo |
|
| Defibrotide/Placebo | Other | Placebo (0.9% sodium chloride) period I: 6.25mg/kg bodyweight defibrotide or placebo (0.9% sodium chloride) period II: vice versa 16 healthy volunteers will receive 2ng/kg bodyweight LPS plus Defibrotide or Placebo 4 healthy volunteers will receive 0.9% saline (NO LPS) plus Defibrotide or Placebo |
|
| Placebo/Placebo | Other | Placebo (0.9% sodium chloride) period I: 6.25mg/kg bodyweight defibrotide or placebo (0.9% sodium chloride) period II: vice versa 16 healthy volunteers will receive 2ng/kg bodyweight LPS plus Defibrotide or Placebo 4 healthy volunteers will receive 0.9% saline (NO LPS) plus Defibrotide or Placebo |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Defibrotide | Drug | 6.25mg/kg bodyweight over 2h infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Prothrombin Fragments f1+2 | Based on the changes from baseline an area-under the concentration-time curve will be calculated and will be compared between the placebo and the verum phase within each subject. The respective arbitrary unit therefore is fold*h. The "placebo period" (4 subjects who did not receive lipopolysaccharide) was only included for a descriptive comparison, but not for statistical comparison | The parameter was assessed at baseline, at 0h, 1h, 2h, 4h, 6h, 24h. |
| Measure | Description | Time Frame |
|---|---|---|
| Thrombin-Antithrombin Complexes | Based on the changes from baseline an area-under the concentration-time curve will be calculated and will be compared between the placebo and the verum phase within each subject. The respective arbitrary unit therefore is fold*h. The "placebo period" (4 subjects who did not receive lipopolysaccharide) was only included for a descriptive comparison, but not for statistical comparison |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Bernd Jilma, MD | Medical University of Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Clinical Pharmacology, Medical University of Vienna | Vienna | 1090 | Austria |
Data will be published in a peer-reviewed medical journal, individual data will not be presented or published, but may be made available by direct request to the PI (data may be made available in an anonymized fashion)
Not provided
Not provided
Not provided
Not provided
Not provided
This was a crossover study. Of 20 healthy volunteers 16 were randomly assigned to receive LPS, while 4 received Placebo only. All participants underwent two study periods: A defibrotide and a placebo period.
The system will not let us enter this study design of a crossover study. Only 20 healthy volunteers participated.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | LPS+ First Defibrotide, Then Placebo | First Intervention: LPS: 2ng/kg bodyweight Defibrotide: 6.25mg/kg bodyweight over 2h infusion Washout for 6 weeks: Second Intervention: LPS: 2ng/kg bodyweight Placebo: 0.9% sodium chloride infusion over 2h infusion |
| FG001 | LPS+ First Placebo, Then Defibrotide |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First Intervention (24 Hours) |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 24, 2017 |
Not provided
Subjects will be randomized to receive LPS (n=16) or placebo (n=4) first. In each group they will undergo two study periods (crossover trial): a placebo period and a defibrotide period. The placebo group (n=4) will only be analyzed descriptively.
Not provided
Not provided
Not provided
|
| Placebo (0.9% sodium chloride) | Drug | (0.9% sodium chloride) infusion over 2h infusion |
|
| Lipopolysaccharide | Drug | bolus infusion of 2ng/kg bodyweight lps |
|
| Placebo (0.9% sodium chloride bolus) | Drug | (0.9% sodium chloride) bolus infusion |
|
| This parameter was assessed at baseline, at 0h, 1h, 2h, 4h, 6h, 24h and AUC was calculated based on these measurements. |
| Plasmin-Antiplasmin Complexes | Based on the changes from baseline an area-under the concentration-time curve will be calculated and will be compared between the placebo and the verum phase within each subject. The respective arbitrary unit therefore is fold*h. The "placebo period" (4 subjects who did not receive lipopolysaccharide) was only included for a descriptive comparison, but not for statistical comparison | This parameter was assessed at baseline, at 0h, 1h, 2h, 4h, and 6h and AUC was calculated based on these measurements. |
| Tumor Necrosis Factor (TNF)-Alpha | Based on the changes from baseline an area-under the concentration-time curve will be calculated and will be compared between the placebo and the verum phase within each subject. The respective arbitrary unit therefore is fold*h. | This parameter was assessed at baseline, at 0h, 1h, 2h, 4h, 6h, 24h and AUC was calculated based on these measurements. |
| Tissue-type Plasminogen Activator | Based on the changes from baseline an area-under the concentration-time curve will be calculated and will be compared between the placebo and the verum phase within each subject. The respective arbitrary unit therefore is fold*h. | This parameter was assessed at baseline, at 0h, 1h, 2h, 4h, 6h, 24h and AUC was calculated based on these measurements. |
| Interleukin-6 | Based on the changes from baseline an area-under the concentration-time curve will be calculated and will be compared between the placebo and the verum phase within each subject. The respective arbitrary unit therefore is fold*h. | This parameter was assessed at baseline, at 0h, 1h, 2h, 4h, 6h, 24h and AUC was calculated based on these measurements. |
| E-Selectin | Based on the changes from baseline an area-under the concentration-time curve will be calculated and will be compared between the placebo and the verum phase within each subject. The respective arbitrary unit therefore is fold*h. | This parameter was assessed at baseline, at 0h, 1h, 2h, 4h, 6h, 24h and AUC was calculated based on these measurements. |
| Plasminogen Activator Inhibitor 1 | Based on the changes from baseline an area-under the concentration-time curve will be calculated and will be compared between the placebo and the verum phase within each subject. The respective arbitrary unit therefore is fold*h. | This parameter was assessed at baseline, at 0h, 1h, 2h, 4h, 6h, 24h and AUC was calculated based on these measurements. |
| Von Willebrand Factor Antigen | Based on the changes from baseline an area-under the concentration-time curve will be calculated and will be compared between the placebo and the verum phase within each subject. The quantification of von Willebrand Factor is based on reference values and results are in % of "normal". The respective arbitrary unit therefore is %*h. | This parameter was assessed at baseline, at 0h, 1h, 2h, 4h, 6h, 24h and AUC was calculated based on these measurements. |
| Clotting Time in Thromboelastometry | In this analysis, first of all a ratio of the measurement time point to the baseline was calculated. Thereafter deltas (baeline-ratio) were calculated. With the results an AUC was calculated. The respective arbitrary unit therefore is fold*h. | This parameter was assessed at baseline, at 0h, 1h, 2h, 4h, 6h, 24h and AUC was calculated based on these measurements. |
| Maximum Lysis in Thromboelastometry | Based on the changes from baseline an area-under the concentration-time curve will be calculated and will be compared between the placebo and the verum phase within each subject. The respective arbitrary unit therefore is fold*h. | This parameter was assessed at baseline, at 0h, 1h, 2h, 4h, 6h and AUC was calculated based on these measurements. |
First Intervention: LPS: 2ng/kg bodyweight Placebo: 0.9% sodium chloride infusion over 2h infusion Washout for 6 weeks: Second Intervention: LPS: 2ng/kg bodyweight Defibrotide: 6.25mg/kg bodyweight over 2h infusion |
| FG002 | Placebo+ First Defibrotide, Then Placebo | 4 healthy volunteers were randomized not to receive LPS. However, they still received Placebo or Defibrotide. This group was included as another control group and to investigate the effects of Defibrotide in vivo. First Intervention: Placebo: bolus infusion of 0.9% sodium chloride solution Defibrotide: 6.25mg/kg bodyweight Defibrotide over 2 hours Washout: 6 weeks Second Intervention: Placebo: bolus infusion of 0.9% sodium chloride solution Placebo: 0.9% sodium chloride solution infusion over 2h |
| FG003 | Placebo+ First Placebo, Then Defibrotide | 4 healthy volunteers were randomized not to receive LPS. However, they still received Placebo or Defibrotide. This group was included as another control group and to investigate the effects of Defibrotide in vivo. 4 healthy volunteers were randomized not to receive LPS. However, they still received Placebo or Defibrotide. This group was included as another control group and to investigate the effects of Defibrotide in vivo. First Intervention: Placebo: bolus infusion of 0.9% sodium chloride solution Placebo: 0.9% sodium chloride solution infusion over 2h Washout: 6 weeks Second Intervention: Placebo: bolus infusion of 0.9% sodium chloride solution Defibrotide: 6.25mg/kg bodyweight Defibrotide over 2 hours |
| COMPLETED |
|
| NOT COMPLETED |
|
| Washout (Minimum of 6 Weeks) |
|
|
| Second Intervention (24 Hours) |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | LPS+ First Defibrotide, Then Placebo | First Intervention: LPS: 2ng/kg bodyweight Defibrotide: 6.25mg/kg bodyweight over 2h infusion Washout for 6 weeks: Second Intervention: LPS: 2ng/kg bodyweight Placebo: 0.9% sodium chloride infusion over 2h infusion |
| BG001 | LPS+ First Placebo, Then Defibrotide | First Intervention: LPS: 2ng/kg bodyweight Placebo: 0.9% sodium chloride infusion over 2h infusion Washout for 6 weeks: Second Intervention: LPS: 2ng/kg bodyweight Defibrotide: 6.25mg/kg bodyweight over 2h infusion |
| BG002 | Placebo+ First Defibrotide, Then Placebo | 4 healthy volunteers were randomized not to receive LPS. However, they still received Placebo or Defibrotide. This group was included as another control group and to investigate the effects of Defibrotide in vivo. First Intervention: Placebo: bolus infusion of 0.9% sodium chloride solution Defibrotide: 6.25mg/kg bodyweight Defibrotide over 2 hours Washout: 6 weeks Second Intervention: Placebo: bolus infusion of 0.9% sodium chloride solution Placebo: 0.9% sodium chloride solution infusion over 2h |
| BG003 | Placebo+ First Placebo, Then Defibrotide | 4 healthy volunteers were randomized not to receive LPS. However, they still received Placebo or Defibrotide. This group was included as another control group and to investigate the effects of Defibrotide in vivo. 4 healthy volunteers were randomized not to receive LPS. However, they still received Placebo or Defibrotide. This group was included as another control group and to investigate the effects of Defibrotide in vivo. First Intervention: Placebo: bolus infusion of 0.9% sodium chloride solution Placebo: 0.9% sodium chloride solution infusion over 2h Washout: 6 weeks Second Intervention: Placebo: bolus infusion of 0.9% sodium chloride solution Defibrotide: 6.25mg/kg bodyweight Defibrotide over 2 hours |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| |||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| ||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Prothrombin Fragments f1+2 | Based on the changes from baseline an area-under the concentration-time curve will be calculated and will be compared between the placebo and the verum phase within each subject. The respective arbitrary unit therefore is fold*h. The "placebo period" (4 subjects who did not receive lipopolysaccharide) was only included for a descriptive comparison, but not for statistical comparison | The main statistical comparison was done for all subjects receiving LPS (defibrotide vs. placebo). The "placebo period" (4 subjects who did not receive lipopolysaccharide) was only included for a descriptive comparison, but not for statistical comparison | Posted | Median | Inter-Quartile Range | fold-change*h | The parameter was assessed at baseline, at 0h, 1h, 2h, 4h, 6h, 24h. |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Thrombin-Antithrombin Complexes | Based on the changes from baseline an area-under the concentration-time curve will be calculated and will be compared between the placebo and the verum phase within each subject. The respective arbitrary unit therefore is fold*h. The "placebo period" (4 subjects who did not receive lipopolysaccharide) was only included for a descriptive comparison, but not for statistical comparison | The main statistical comparison was done for all subjects receiving LPS (defibrotide vs. placebo). The "placebo period" (4 subjects who did not receive lipopolysaccharide) was only included for a descriptive comparison, but not for statistical comparison | Posted | Median | Inter-Quartile Range | fold*h | This parameter was assessed at baseline, at 0h, 1h, 2h, 4h, 6h, 24h and AUC was calculated based on these measurements. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Plasmin-Antiplasmin Complexes | Based on the changes from baseline an area-under the concentration-time curve will be calculated and will be compared between the placebo and the verum phase within each subject. The respective arbitrary unit therefore is fold*h. The "placebo period" (4 subjects who did not receive lipopolysaccharide) was only included for a descriptive comparison, but not for statistical comparison | The main statistical comparison was done for all subjects receiving LPS (defibrotide vs. placebo). The "placebo period" (4 subjects who did not receive lipopolysaccharide) was only included for a descriptive comparison, but not for statistical comparison | Posted | Median | Inter-Quartile Range | fold*h | This parameter was assessed at baseline, at 0h, 1h, 2h, 4h, and 6h and AUC was calculated based on these measurements. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Tumor Necrosis Factor (TNF)-Alpha | Based on the changes from baseline an area-under the concentration-time curve will be calculated and will be compared between the placebo and the verum phase within each subject. The respective arbitrary unit therefore is fold*h. | The "placebo period" (4 subjects who did not receive lipopolysaccharide) was only included for a descriptive comparison, but not for statistical comparison | Posted | Median | Inter-Quartile Range | fold*h | This parameter was assessed at baseline, at 0h, 1h, 2h, 4h, 6h, 24h and AUC was calculated based on these measurements. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Tissue-type Plasminogen Activator | Based on the changes from baseline an area-under the concentration-time curve will be calculated and will be compared between the placebo and the verum phase within each subject. The respective arbitrary unit therefore is fold*h. | The main statistical comparison was done for all subjects receiving LPS (defibrotide vs. placebo). The "placebo period" (4 subjects who did not receive lipopolysaccharide) was only included for a descriptive comparison, but not for statistical comparison | Posted | Median | Inter-Quartile Range | fold*h | This parameter was assessed at baseline, at 0h, 1h, 2h, 4h, 6h, 24h and AUC was calculated based on these measurements. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Interleukin-6 | Based on the changes from baseline an area-under the concentration-time curve will be calculated and will be compared between the placebo and the verum phase within each subject. The respective arbitrary unit therefore is fold*h. | The main statistical comparison was done for all subjects receiving LPS (defibrotide vs. placebo). The "placebo period" (4 subjects who did not receive lipopolysaccharide) was only included for a descriptive comparison, but not for statistical comparison | Posted | Median | Inter-Quartile Range | fold*h | This parameter was assessed at baseline, at 0h, 1h, 2h, 4h, 6h, 24h and AUC was calculated based on these measurements. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | E-Selectin | Based on the changes from baseline an area-under the concentration-time curve will be calculated and will be compared between the placebo and the verum phase within each subject. The respective arbitrary unit therefore is fold*h. | The main statistical comparison was done for all subjects receiving LPS (defibrotide vs. placebo). The "placebo period" (4 subjects who did not receive lipopolysaccharide) was only included for a descriptive comparison, but not for statistical comparison | Posted | Median | Inter-Quartile Range | fold*h | This parameter was assessed at baseline, at 0h, 1h, 2h, 4h, 6h, 24h and AUC was calculated based on these measurements. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Plasminogen Activator Inhibitor 1 | Based on the changes from baseline an area-under the concentration-time curve will be calculated and will be compared between the placebo and the verum phase within each subject. The respective arbitrary unit therefore is fold*h. | The main statistical comparison was done for all subjects receiving LPS (defibrotide vs. placebo). The "placebo period" (4 subjects who did not receive lipopolysaccharide) was only included for a descriptive comparison, but not for statistical comparison | Posted | Median | Inter-Quartile Range | fold*h | This parameter was assessed at baseline, at 0h, 1h, 2h, 4h, 6h, 24h and AUC was calculated based on these measurements. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Von Willebrand Factor Antigen | Based on the changes from baseline an area-under the concentration-time curve will be calculated and will be compared between the placebo and the verum phase within each subject. The quantification of von Willebrand Factor is based on reference values and results are in % of "normal". The respective arbitrary unit therefore is %*h. | The main statistical comparison was done for all subjects receiving LPS (defibrotide vs. placebo). The "placebo period" (4 subjects who did not receive lipopolysaccharide) was only included for a descriptive comparison, but not for statistical comparison. | Posted | Median | Inter-Quartile Range | %*h | This parameter was assessed at baseline, at 0h, 1h, 2h, 4h, 6h, 24h and AUC was calculated based on these measurements. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Clotting Time in Thromboelastometry | In this analysis, first of all a ratio of the measurement time point to the baseline was calculated. Thereafter deltas (baeline-ratio) were calculated. With the results an AUC was calculated. The respective arbitrary unit therefore is fold*h. | The main statistical comparison was done for all subjects receiving LPS (defibrotide vs. placebo). The "placebo period" (4 subjects who did not receive lipopolysaccharide) was only included for a descriptive comparison, but not for statistical comparison. | Posted | Median | Inter-Quartile Range | fold*h | This parameter was assessed at baseline, at 0h, 1h, 2h, 4h, 6h, 24h and AUC was calculated based on these measurements. |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Maximum Lysis in Thromboelastometry | Based on the changes from baseline an area-under the concentration-time curve will be calculated and will be compared between the placebo and the verum phase within each subject. The respective arbitrary unit therefore is fold*h. | The main statistical comparison was done for all subjects receiving LPS (defibrotide vs. placebo). The "placebo period" (4 subjects who did not receive lipopolysaccharide) was only included for a descriptive comparison, but not for statistical comparison. | Posted | Median | Inter-Quartile Range | fold*h | This parameter was assessed at baseline, at 0h, 1h, 2h, 4h, 6h and AUC was calculated based on these measurements. |
|
For the individual subject, adverse events were assessed during every study visit (screening, study day1, study day 2, follow up) during the whole study. The whole study period lastet for a minimum of 8 weeks, but could be longer for individual subjects (washout period was a minimum of 6 weeks). The respective time frame could therefore differ between the individual subjects but was a minimum of 8 weeks.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Defibrotide Plus LPS | Intervention: 6.25mg/kg bodyweight defibrotide infusion plus 2ng/kg bodyweight LPS infusion | 0 | 16 | 0 | 16 | 13 | 16 |
| EG001 | Placebo Plus LPS | Intervention: placebo infusion (0.9% sodium chloride solution) plus 2ng/kg bodyweight LPS infusion | 0 | 16 | 0 | 16 | 15 | 16 |
| EG002 | Defibrotide Plus Placebo | Intervention: 6.25mg/kg bodyweight defibrotide infusion plus placebo bolus infusion (0.9% sodium chloride solution) | 0 | 3 | 0 | 3 | 1 | 3 |
| EG003 | Placebo/Placebo | Intervention: placebo infusion (0.9% sodium chloride solution) plus placebo bolus infusion (0.9% sodium chloride solution) | 0 | 4 | 0 | 4 | 1 | 4 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Vertigo | Nervous system disorders | Systematic Assessment |
| ||
| Flu-like Symptoms | General disorders | Systematic Assessment |
| ||
| Arthralgia | General disorders | Systematic Assessment |
| ||
| Chills | General disorders | Systematic Assessment | Feeling Cold |
| |
| Impaired Concentration | General disorders | Systematic Assessment |
| ||
| Fatigue | General disorders | Systematic Assessment |
| ||
| Precollapse | General disorders | Systematic Assessment |
| ||
| Dizziness | General disorders | Systematic Assessment |
| ||
| Nausea | General disorders | Systematic Assessment |
| ||
| Urticarial rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Univ.Prof. Dr. Bernd Jilma | Medical University of Vienna | +4314040029810 | bernd.jilma@meduniwien.ac.at |
| Aug 18, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D019446 | Endotoxemia |
| D013927 | Thrombosis |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D016470 | Bacteremia |
| D018805 | Sepsis |
| D007239 | Infections |
| D014115 | Toxemia |
| D018746 | Systemic Inflammatory Response Syndrome |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C036901 | defibrotide |
| D012965 | Sodium Chloride |
| D008070 | Lipopolysaccharides |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D011135 | Polysaccharides, Bacterial |
| D011134 | Polysaccharides |
| D008055 | Lipids |
| D000942 | Antigens, Bacterial |
| D000941 | Antigens |
| D001685 | Biological Factors |
| D004731 | Endotoxins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
Not provided
Not provided
|
|
|
|
|
| OG003 | Placebo Plus Placebo | Intervention: placebo infusion (0.9% sodium chloride) plus placebo bolus infusion (0.9% sodium chloride) |
|
|
|
| OG003 | Placebo Plus Placebo | Intervention: placebo infusion (0.9% sodium chloride) and placebo bolus infusion (0.9% sodium chloride) |
|
|
|
Intervention: placebo infusion (0.9% sodium chloride) plus placebo bolus infusion (0.9% sodium chloride) |
|
|
|
| Placebo Plus Placebo |
Intervention: placebo bolus (0.9% sodium chloride) plus placebo (0.9% sodium chloride) infusion |
|
|
|
| Placebo Plus Placebo |
Intervention: Placebo (0.9% sodium chloride) bolus infusion plus placebo (0.9% sodium chloride) infusion |
|
|
|
| Placebo Plus Placebo |
Intervention: placebo infusion (0.9% sodium chloride) plus placebo bolus infusion (0.9% sodium chloride) |
|
|
|
| Placebo Plus Placebo |
Intervention: placebo (0.9% sodium chloride) infusion plus placebo (0.9% sodium chloride) bolus infusion |
|
|
|
| OG003 | Placebo Plus Placebo | Intervention: Placebo (0.9% sodium chloride solution) infusion plus placebo bolus infusion (0.9% sodium chloride) |
|
|
|
| OG003 |
| Placebo Plus Placebo |
Intervention: placebo (0.9%sodium chloride solution) infusion plus placebo bolus infusion (0.9% sodium chloride solution) |
|
|
|
| Placebo Plus Placebo |
Intervention: placebo (0.9% sodium chloride) infusion plus placebo (0.9% sodium chloride) bolus infusion |
|
|
|