Trial · NCT00628498
Defibrotide for Patients With Hepatic Veno-occlusive Disease: A Treatment IND Study
NCT00628498, Phase 3, Completed, Jazz Pharmaceuticals; results first posted 2017-11-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Defibrotide for Patients With Hepatic Veno-occlusive Disease: A Treatment IND Study. Trials, record NCT00628498. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00628498
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Defibrotide for Patients With Hepatic Veno-occlusive Disease: A Treatment IND Study
- NCT number
- NCT00628498
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,206 participants, actual
- Lead sponsor
- Jazz Pharmaceuticals
- Conditions
- Hepatic Veno-Occlusive Disease
- Interventions
- Defibrotide, Defibrotide
- First posted
- 2008-03-05
- Last updated
- 2017-11-30
- Results first posted
- 2017-11-30
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Survival by Day+100 Post Stem Cell Transplant or Chemotherapy | Day +100 from HSCT or 100 days from start of chemotherapy |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Survival by Day+100 Post Stem Cell Transplant or Chemotherapy | Day +100 from HSCT or 100 days from start of chemotherapy | ITT Efficacy Population | Percentage of participants alive | NUMBER |
Source ClinicalTrials.gov
Results by group1
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Survival by Day+100 Post Stem Cell Transplant or Chemotherapy | Defibrotide | 49.9 | 95% Confidence Interval 45.8 to 54.0 | Percentage of participants alive |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Defibrotide | 1,206 | |
| Overall Study | COMPLETED | Defibrotide | 1,154 | |
| Overall Study | NOT COMPLETED | Defibrotide | 52 |
Source ClinicalTrials.gov
Adverse events281
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hypotension | Vascular disorders | Defibrotide | 93 | 1,154 | |
| other | Diarrhoea | Gastrointestinal disorders | Defibrotide | 70 | 1,154 | |
| other | Vomiting | Gastrointestinal disorders | Defibrotide | 63 | 1,154 | |
| serious | Febrile neutropenia | Blood and lymphatic system disorders | Defibrotide | 6 | 1,154 | |
| serious | Coagulopathy | Blood and lymphatic system disorders | Defibrotide | 5 | 1,154 | |
| serious | Disseminated intravascular coagulation | Blood and lymphatic system disorders | Defibrotide | 5 | 1,154 | |
| serious | Anaemia | Blood and lymphatic system disorders | Defibrotide | 2 | 1,154 | |
| serious | Thrombocytopenia | Blood and lymphatic system disorders | Defibrotide | 2 | 1,154 | |
| serious | Haemolysis | Blood and lymphatic system disorders | Defibrotide | 1 | 1,154 | |
| serious | Haemolytic anaemia | Blood and lymphatic system disorders | Defibrotide | 1 | 1,154 |
1 to 10 of 281Source ClinicalTrials.gov
See all 281 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Defibrotide | ||
| Total, other adverse events | Defibrotide | 166 | 1,154 |
| Total, serious adverse events | Defibrotide | 598 | 1,154 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00628498
GET https://conductscience.org/api/trials/v1/NCT00628498/events?page=2