Trial · NCT00003966
Defibrotide in Treating Patients With Liver Damage Following Peripheral Stem Cell Transplantation
NCT00003966, Phase 2, Completed, Dana-Farber Cancer Institute
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Defibrotide in Treating Patients With Liver Damage Following Peripheral Stem Cell Transplantation. Trials, record NCT00003966. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00003966
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Defibrotide in Treating Patients With Liver Damage Following Peripheral Stem Cell Transplantation
- NCT number
- NCT00003966
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 151 participants, actual
- Lead sponsor
- Dana-Farber Cancer Institute
- Conditions
- Veno-occlusive Disease
- Interventions
- defibrotide
- First posted
- 2003-01-27
- Last updated
- 2017-01-20
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete Response Rate as measured by a total bilirubin of < 2 mg/dL and resolution of multi-organ failure attributable to veno-occlusive disease (VOD) | 60 Days | |
| Secondary | Survival at 100 days following stem cell transplantation | 100 days following stem cell transplantation | |
| Secondary | Toxicity by NCI Common Toxicity Criteria version 2.0 during study and 30 days after study completion | during study and 30 Days after study completion | |
| Secondary | Grade 3-4 end organ dysfunction attributable to defibrotide as determined by NCI Common Toxicity Criteria version 2.0 during study and 30 days after study completion | during study and 30 Days after study completion | |
| Secondary | Occurrence of other adverse events by NCI Common Toxicity Criteria version 2.0 during study and 30 days after study completion | during study and 30 Days after study completion | |
| Secondary | Effect of drug on plasminogen activator inhibitor-1 (PAI-1) determination of dose-relationship between drug and/or VOD response as measured by survival, PAI-1 levels, and research assays at day 100 | 100 Days | |
| Secondary | Feasibility of pharmacokinetics (PK) across dose arms and the PK of defibrotide by PK analysis |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA015704 | Cancer Center Support Grant | LYNCH, THOMAS JAMES | FRED HUTCHINSON CANCER CENTER | NATIONAL CANCER INSTITUTE | 1985 to 2025 |
Source NIH RePORTER
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/NCT00003966
GET https://conductscience.org/api/trials/v1/NCT00003966/registered