CompletedNCT02876601LPS_DFUpdated Dec 19, 2019Results posted

Defibrotide in the Human Endotoxemia Model --- an Exploratory Trial Investigating the Effects and the Mechanisms of Defibrotide

A Phase 4 interventional study of Defibrotide and Placebo (0.9% sodium chloride) in Healthy Volunteers and Endotoxemia, sponsored by Bernd Jilma. Completed at 1 site in Austria. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-12-19.

Sponsored by Bernd Jilma · Phase 4, Interventional, and Basic science

Phase: Phase 4
Study type: Interventional
Enrollment: 20
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

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.

Read the detailed description

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.

Conditions studied

Healthy Volunteers
Endotoxemia

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Keywords

Coagulation
Inflammation
Defibrotide
Fibrinolysis

In context

Endotoxemia

81 studies on the registry are indexed under Endotoxemia; 7 are open to participants now.

This study's enrollment of 20 is below the median of 31 across 70 interventional studies indexed under Endotoxemia.

Browse Endotoxemia studies →

Lead sponsor

This is the only study on the registry with Bernd Jilma as lead sponsor.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

>18 years of age
\<90kg body weight
Normal findings in medical history and physical examination unless the investigator considers the abnormality to be clinically irrelevant
Normal laboratory values unless the investigator considers abnormalities to be clinically irrelevant
Ability to understand the purpose and nature of the study, as well as the associated risks

Exclusion criteria

Exclusion Criteria:

Intake of any drugs that may interfere with the trial's endpoints or drugs (i.e. inhibitors, anticoagulants, etc.)
Positive results of or hepatitis virology
Acute illness with systemic inflammatory reactions
Known allergies, or intolerances to any of the used substances
Acute or recent bleeding episodes, increased risk of bleeding at the discretion of the investigator
Participation in an LPS trial within 6 weeks of the first study day
Pregnancy or breastfeeding

Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Study design

Phase: Phase 4
Primary purpose: Basic science
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 20 participants (actual)

Study arms

Active comparator
Defibrotide/LPS
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
Drug: Defibrotide · Drug: Lipopolysaccharide
Placebo comparator
Placebo/LPS
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
Drug: Placebo (0.9% sodium chloride) · Drug: Lipopolysaccharide
Other
Defibrotide/Placebo
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
Drug: Defibrotide · Drug: Placebo (0.9% sodium chloride bolus)
Other
Placebo/Placebo
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
Drug: Placebo (0.9% sodium chloride) · Drug: Placebo (0.9% sodium chloride bolus)

Interventions

DrugDefibrotide
6.25mg/kg bodyweight over 2h infusion
DrugPlacebo (0.9% sodium chloride)
(0.9% sodium chloride) infusion over 2h infusion
DrugLipopolysaccharide
bolus infusion of 2ng/kg bodyweight lps
DrugPlacebo (0.9% sodium chloride bolus)
(0.9% sodium chloride) bolus infusion

What researchers measure

Primary outcomes

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
Time frame: The parameter was assessed at baseline, at 0h, 1h, 2h, 4h, 6h, 24h.

Secondary outcomes

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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: This parameter was assessed at baseline, at 0h, 1h, 2h, 4h, 6h and AUC was calculated based on these measurements.

Results

Posted Dec 19, 2019

Participant flow

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.

First Intervention (24 Hours)

Participant flow — First Intervention (24 Hours)
Milestone	LPS+ First Defibrotide, Then Placebo	LPS+ First Placebo, Then Defibrotide	Placebo+ First Defibrotide, Then Placebo	Placebo+ First Placebo, Then Defibrotide
Started	8	8	2	2
Completed	8	8	2	2
Not completed	0	0	0	0

Washout (Minimum of 6 Weeks)

Participant flow — Washout (Minimum of 6 Weeks)
Milestone	LPS+ First Defibrotide, Then Placebo	LPS+ First Placebo, Then Defibrotide	Placebo+ First Defibrotide, Then Placebo	Placebo+ First Placebo, Then Defibrotide
Started	8	8	2	2
Completed	8	8	1	2
Not completed	0	0	1	0
Withdrew: Unforeseen unavailability	0	0	1	0

Second Intervention (24 Hours)

Participant flow — Second Intervention (24 Hours)
Milestone	LPS+ First Defibrotide, Then Placebo	LPS+ First Placebo, Then Defibrotide	Placebo+ First Defibrotide, Then Placebo	Placebo+ First Placebo, Then Defibrotide
Started	8	8	1	2
Completed	8	8	1	2
Not completed	0	0	0	0

Outcome measures

PrimaryProthrombin 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

Time frame:: The parameter was assessed at baseline, at 0h, 1h, 2h, 4h, 6h, 24h.
Reported as:: Median · fold-change*h

Prothrombin Fragments f1+2
fold-change*h	LPS Plus Defibrotide	LPS Plus Placebo	Placebo Plus Defibrotide	Placebo Plus Placebo
Prothrombin Fragments f1+2	31.1 (16.96 to 61.6)	34.08 (20.38 to 60.8)	27.41 (27.21 to 46.48)	36.02 (23.64 to 51.95)

Statistical analysis

LPS Plus Defibrotide vs LPS Plus Placebo · Wilcoxon (Mann-Whitney) · p = 0.408

SecondaryThrombin-Antithrombin Complexes

Time frame:: This parameter was assessed at baseline, at 0h, 1h, 2h, 4h, 6h, 24h and AUC was calculated based on these measurements.
Reported as:: Median · fold*h

Thrombin-Antithrombin Complexes
fold*h	LPS Plus Defibrotide	LPS Plus Placebo	Placebo Plus Defibrotide	Placebo Plus Placebo
Thrombin-Antithrombin Complexes	23.39 (15.19 to 32.52)	27.4 (21.47 to 41.57)	17.46 (15.58 to 20.46)	21.83 (16.09 to 23.26)

Statistical analysis

LPS Plus Defibrotide vs LPS Plus Placebo · Wilcoxon (Mann-Whitney) · p = 0.148

SecondaryPlasmin-Antiplasmin Complexes

Time frame:: This parameter was assessed at baseline, at 0h, 1h, 2h, 4h, and 6h and AUC was calculated based on these measurements.
Reported as:: Median · fold*h

Plasmin-Antiplasmin Complexes
fold*h	LPS Plus Defibrotide	LPS/Placebo	Placebo Plus Defibrotide	Placebo Plus Placebo
Plasmin-Antiplasmin Complexes	11.8 (9.59 to 15.12)	9.99 (8.15 to 13.16)	7 (6.31 to 7.19)	7.12 (6.34 to 7.79)

Statistical analysis

LPS Plus Defibrotide vs LPS/Placebo · Wilcoxon (Mann-Whitney) · p = 0.039

SecondaryTumor Necrosis Factor (TNF)-Alpha

Time frame:: This parameter was assessed at baseline, at 0h, 1h, 2h, 4h, 6h, 24h and AUC was calculated based on these measurements.
Reported as:: Median · fold*h

Tumor Necrosis Factor (TNF)-Alpha
fold*h	LPS Plus Defibrotide	LPS Plus Placebo	Placebo Plus Defibrotide	Placebo Plus Placebo
Tumor Necrosis Factor (TNF)-Alpha	286 (162 to 453)	326 (172 to 366)	28.08 (22.19 to 28.35)	21.01 (16.75 to 25.27)

Statistical analysis

LPS Plus Defibrotide vs LPS Plus Placebo · Wilcoxon (Mann-Whitney) · p = 0.642

SecondaryTissue-type Plasminogen Activator

Time frame:: This parameter was assessed at baseline, at 0h, 1h, 2h, 4h, 6h, 24h and AUC was calculated based on these measurements.
Reported as:: Median · fold*h

Tissue-type Plasminogen Activator
fold*h	LPS Plus Defibrotide	LPS Plus Placebo	Placebo Plus Defibrotide	Placebo Plus Placebo
Tissue-type Plasminogen Activator	21.8 (14.9 to 29.3)	17 (13.9 to 23.9)	20.57 (19.75 to 21.45)	23.54 (21.72 to 24.78)

Statistical analysis

LPS Plus Defibrotide vs LPS Plus Placebo · Wilcoxon (Mann-Whitney) · p = 0.026

SecondaryInterleukin-6

Time frame:: This parameter was assessed at baseline, at 0h, 1h, 2h, 4h, 6h, 24h and AUC was calculated based on these measurements.
Reported as:: Median · fold*h

Interleukin-6
fold*h	LPS Plus Defibrotide	LPS Plus Placebo	Placebo Plus Defibrotide	Placebo Plus Placebo
Interleukin-6	1543 (815 to 2919)	1144 (22 to 1923)	35 (32 to 113)	31 (23 to 51)

Statistical analysis

LPS Plus Defibrotide vs LPS Plus Placebo · Wilcoxon (Mann-Whitney) · p = 0.326

SecondaryE-Selectin

Time frame:: This parameter was assessed at baseline, at 0h, 1h, 2h, 4h, 6h, 24h and AUC was calculated based on these measurements.
Reported as:: Median · fold*h

E-Selectin
fold*h	LPS Plus Defibrotide	LPS Plus Placebo	Placebo Plus Defibrotide	Placebo Plus Placebo
E-Selectin	35 (32 to 40)	33 (24 to 45)	21 (18 to 36)	41 (20 to 63)

Statistical analysis

LPS Plus Defibrotide vs LPS Plus Placebo · Wilcoxon (Mann-Whitney) · p = 0.796

SecondaryPlasminogen Activator Inhibitor 1

Time frame:: This parameter was assessed at baseline, at 0h, 1h, 2h, 4h, 6h, 24h and AUC was calculated based on these measurements.
Reported as:: Median · fold*h

Plasminogen Activator Inhibitor 1
fold*h	LPS Plus Defibrotide	LPS Plus Placebo	Placebo Plus Defibrotide	Placebo Plus Placebo
Plasminogen Activator Inhibitor 1	216 (32 to 898)	477 (49 to 1000)	25 (25 to 29.5)	24.86 (22.7 to 25)

Statistical analysis

LPS Plus Defibrotide vs LPS Plus Placebo · Wilcoxon (Mann-Whitney) · p = 0.918

SecondaryVon 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.

Time frame:: This parameter was assessed at baseline, at 0h, 1h, 2h, 4h, 6h, 24h and AUC was calculated based on these measurements.
Reported as:: Median · %*h

Von Willebrand Factor Antigen
%*h	LPS Plus Defibrotide	LPS Plus Placebo	Placebo Plus Defibrotie	Placebo Plus Placebo
Von Willebrand Factor Antigen	54 (41 to 70)	53 (41 to 65)	27 (27 to 31)	26 (24 to 29)

Statistical analysis

LPS Plus Defibrotide vs LPS Plus Placebo · Wilcoxon (Mann-Whitney) · p = 0.877

SecondaryClotting 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.

Time frame:: This parameter was assessed at baseline, at 0h, 1h, 2h, 4h, 6h, 24h and AUC was calculated based on these measurements.
Reported as:: Median · fold*h

Clotting Time in Thromboelastometry
fold*h	LPS Plus Defibrotide	LPS Plus Placebo	Placebo Plus Defibrotide	Placebo Plus Placebo
Clotting Time in Thromboelastometry	1.12 (0.8 to 1.43)	1.12 (1.04 to 1.41)	-0.2 (-6 to 2.17)	2.14 (0.31 to 4.28)

Statistical analysis

LPS Plus Defibrotide vs LPS Plus Placebo · Wilcoxon (Mann-Whitney) · p = 0.423

SecondaryMaximum Lysis in Thromboelastometry

Time frame:: This parameter was assessed at baseline, at 0h, 1h, 2h, 4h, 6h and AUC was calculated based on these measurements.
Reported as:: Median · fold*h

Maximum Lysis in Thromboelastometry
fold*h	LPS Plus Defibrotide	LPS Plus Placebo	Placebo Plus Defibrotide	Placebo Plus Placebo
Maximum Lysis in Thromboelastometry	7.9 (7.1 to 10.1)	7.7 (6.6 to 9)	6.84 (6.72 to 7.07)	6.85 (6.32 to 7.05)

Statistical analysis

LPS Plus Defibrotide vs LPS Plus Placebo · Wilcoxon (Mann-Whitney) · p = 0.938

Adverse events

Collected over 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.. Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Defibrotide Plus LPS	0/16 (0%)	0/16 (0%)	13/16 (81.3%)
Placebo Plus LPS	0/16 (0%)	0/16 (0%)	15/16 (93.8%)
Defibrotide Plus Placebo	0/3 (0%)	0/3 (0%)	1/3 (33.3%)
Placebo/Placebo	0/4 (0%)	0/4 (0%)	1/4 (25%)

Most frequent other events

Showing 10 of 11

Most frequent other events
Event	Defibrotide Plus LPS	Placebo Plus LPS	Defibrotide Plus Placebo	Placebo/Placebo
HeadacheNervous system disorders	13/16	11/16	0/3	1/4
ArthralgiaGeneral disorders	2/16	7/16	0/3	0/4
Flu-like SymptomsGeneral disorders	6/16	6/16	0/3	0/4
ChillsGeneral disorders	3/16	6/16	0/3	0/4
Urticarial rashSkin and subcutaneous tissue disorders	0/16	0/16	1/3	0/4
NauseaGeneral disorders	2/16	1/16	0/3	0/4
VertigoNervous system disorders	1/16	0/16	0/3	0/4
Impaired ConcentrationGeneral disorders	0/16	1/16	0/3	0/4
FatigueGeneral disorders	0/16	1/16	0/3	0/4
PrecollapseGeneral disorders	1/16	0/16	0/3	0/4

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	LPS+ First Defibrotide, Then Placebo	LPS+ First Placebo, Then Defibrotide	Placebo+ First Defibrotide, Then Placebo	Placebo+ First Placebo, Then Defibrotide	Total
<=18 years	0	0	0	0	0
Between 18 and 65 years	8	8	2	2	20
>=65 years	0	0	0	0	0

Age, Continuous
Age, Continuous(years)	LPS+ First Defibrotide, Then Placebo	LPS+ First Placebo, Then Defibrotide	Placebo+ First Defibrotide, Then Placebo	Placebo+ First Placebo, Then Defibrotide	Total
Mean	32 ± 9	29 ± 7	41 ± 8	21 ± 0	31 ± 9

Sex: Female, Male
Sex: Female, Male(Participants)	LPS+ First Defibrotide, Then Placebo	LPS+ First Placebo, Then Defibrotide	Placebo+ First Defibrotide, Then Placebo	Placebo+ First Placebo, Then Defibrotide	Total
Female	0	0	0	2	2
Male	8	8	2	0	18

Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)	LPS+ First Defibrotide, Then Placebo	LPS+ First Placebo, Then Defibrotide	Placebo+ First Defibrotide, Then Placebo	Placebo+ First Placebo, Then Defibrotide	Total
Count of participants	—	—	—	—	0

Region of Enrollment
Region of Enrollment(participants)	LPS+ First Defibrotide, Then Placebo	LPS+ First Placebo, Then Defibrotide	Placebo+ First Defibrotide, Then Placebo	Placebo+ First Placebo, Then Defibrotide	Total
Austria	8	8	2	2	20

Study locations

1 site

Department of Clinical Pharmacology, Medical University of Vienna
Vienna, 1090, Austria

References and documents

Study documents

Protocol and statistical analysis plan ↗ · Jul 24, 2017

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No — 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)

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2017 to primary completion in Feb 2018, 9 months.

Results were first posted in Dec 2019, 1 year 10 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered: Jun 27, 2016
First posted: Aug 24, 2016
StartActual: Apr 18, 2017
Primary completionActual: Feb 12, 2018
CompletionActual: Feb 12, 2018
Results first posted: Dec 19, 2019
Last update: Dec 19, 2019

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Dec 19, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02876601
Lead sponsor: Bernd Jilma
Responsible party: Bernd Jilma (Ao.Univ.Prof.Dr.med, Medical University of Vienna) — Sponsor-investigator
First posted: Aug 24, 2016
Start date: Apr 18, 2017
Primary completion: Feb 12, 2018
Completion: Feb 12, 2018
Results posted: Dec 19, 2019
Last update: Dec 19, 2019

Study contacts

Bernd Jilma, MD

principal investigator · Medical University of Vienna

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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Defibrotide in the Human Endotoxemia Model --- an Exploratory Trial Investigating the Effects and the Mechanisms of Defibrotide

Study summary

Conditions studied

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Keywords

In context

Endotoxemia

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Who can participate

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Interventions

What researchers measure

Primary outcomes

Secondary outcomes

Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

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References and documents

Study documents

Individual participant data

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Follow this study

Discussion

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