Trial · NCT00149890
Efficacy and Safety of Basiliximab, Cyclosporine/Cyclosporine Microemulsion, and Steroids in Pediatric de Novo Liver Transplant Recipients Avoiding Intraoperative Steroids
NCT00149890, Phase 3, Completed, Novartis; results first posted 2011-09-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Basiliximab, Cyclosporine/Cyclosporine Microemulsion, and Steroids in Pediatric de Novo Liver Transplant Recipients Avoiding Intraoperative Steroids. Trials, record NCT00149890. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00149890
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Basiliximab, Cyclosporine/Cyclosporine Microemulsion, and Steroids in Pediatric de Novo Liver Transplant Recipients Avoiding Intraoperative Steroids
- NCT number
- NCT00149890
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 77 participants, actual
- Lead sponsor
- Novartis
- Conditions
- Liver Transplantation, Infection
- Interventions
- Basiliximab, Cyclosporine/cyclosporine microemulsion, Steroid
- First posted
- 2005-09-08
- Last updated
- 2011-09-22
- Results first posted
- 2011-09-22
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With at Least One Biopsy Proven Acute Rejection (BPAR) Episode, Graft Loss or Death Within the First Three Months Post-transplantation | 3 months after treatment | Graft loss is defined as being listed for a re-transplantation. The analysis was based on the locally performed biopsy assessments. Generally, patients not experiencing a relevant event (i.e., acute rejection, graft loss or death) were censored with the last visit date. |
| Secondary | Number of Participants With Biopsy Proven Acute Rejection (BPAR) Episodes Within the First Three Months | 3 months | At biopsy of transplanted tissue sample, acute rejection has an onset 2-60 days after transplantation, with interstitial vascular endothelial cell swelling, interstitial accumulation of lymphocytes, plasma cells, immunoblasts, macrophages, neutrophils; tubular separation with edema/necrosis of tubular epithelium; swelling and vacuolization of the endothelial cells, vascular edema, bleeding and inflammation. Clinical signs and symptoms include malaise, fever, and hypertension. |
| Secondary | Number of Participants With Steroid Resistant Rejection Episodes Within Three and Six Months | 3 and 6 months | To evaluate the efficacy of a regimen with intraoperative versus without intraoperative steroids in combination with basiliximab, cyclosporine/cyclosporine microemulsion and steroids as measured by the incidence of steroid resistant rejection episodes within three and six months. |
| Secondary | Percentage of Participants Experiencing Death or Graft Loss Within Three and Six Months After Transplantation | 3 months and 6 months | Graft loss is defined as being listed for a re-transplantation. |
| Secondary | Number of Participants With Bacterial, Viral and Fungal Infections During Six Months | 6 months | To evaluate the safety of a regimen with intraoperative versus without intraoperative steroids in combination with basiliximab, cyclosporine/cyclosporine microemulsion and steroids as measured by the episodes of bacterial, viral and fungal infections during six months. |
| Secondary | Time of Onset of a First Biopsy Proven Acute Rejection | 6 months | Biopsied Tissue shows rejection at onset 2-60 days after transplantation, with interstitial vascular endothelial cell swelling, interstitial accumulation of lymphocytes, plasma cells, immunoblasts, macrophages, neutrophils; tubular separation with edema/necrosis of tubular epithelium; swelling and vacuolization of the endothelial cells, vascular edema, bleeding and inflammation. Clinical signs and symptoms include malaise, fever and hypertension . |
| Secondary | Percentage of Participants With Treatment Failure Within Three and Six Months | 3 and 6 months | To evaluate the proportion of patients with treatment failure treated with a therapy consisting of intraoperative versus without intraoperative steroids in combination with basiliximab, cyclosporine/cyclosporine microemulsion and steroids within three and six months. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With at Least One Biopsy Proven Acute Rejection (BPAR) Episode, Graft Loss or Death Within the First Three Months Post-transplantation | 3 months after treatment | safety/Intent to Treat (ITT) population | Participants | NUMBER |
| SECONDARY | Number of Participants With Biopsy Proven Acute Rejection (BPAR) Episodes Within the First Three Months | 3 months | safety/Intent to Treat (ITT) population | Participants | NUMBER |
| SECONDARY | Number of Participants With Steroid Resistant Rejection Episodes Within Three and Six Months | 3 and 6 months | safety/Intent to Treat (ITT) population | Participants | NUMBER |
| SECONDARY | Percentage of Participants Experiencing Death or Graft Loss Within Three and Six Months After Transplantation | 3 months and 6 months | safety/Intent to Treat (ITT) population | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Bacterial, Viral and Fungal Infections During Six Months | 6 months | Safety Population | Participants | NUMBER |
| SECONDARY | Time of Onset of a First Biopsy Proven Acute Rejection | 6 months | safety/Intent to Treat (ITT) population | Months | MEDIAN |
| SECONDARY | Percentage of Participants With Treatment Failure Within Three and Six Months | 3 and 6 months | Intention to treat population | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group40
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With at Least One Biopsy Proven Acute Rejection (BPAR) Episode, Graft Loss or Death Within the First Three Months Post-transplantation | With Intraoperative Steroids | Stratum age < 2 years (N=21, 24) | 8 | Participants | |
| Number of Participants With at Least One Biopsy Proven Acute Rejection (BPAR) Episode, Graft Loss or Death Within the First Three Months Post-transplantation | Without Intraoperative Steroids | Stratum age < 2 years (N=21, 24) | 15 | Participants | |
| Number of Participants With at Least One Biopsy Proven Acute Rejection (BPAR) Episode, Graft Loss or Death Within the First Three Months Post-transplantation | With Intraoperative Steroids | Stratum age 2-16 years (N=18, 14) | 14 | Participants | |
| Number of Participants With at Least One Biopsy Proven Acute Rejection (BPAR) Episode, Graft Loss or Death Within the First Three Months Post-transplantation | Without Intraoperative Steroids | Stratum age 2-16 years (N=18, 14) | 11 | Participants | |
| Number of Participants With at Least One Biopsy Proven Acute Rejection (BPAR) Episode, Graft Loss or Death Within the First Three Months Post-transplantation | With Intraoperative Steroids | Total (N= 39, 38) | 22 | Participants | |
| Number of Participants With at Least One Biopsy Proven Acute Rejection (BPAR) Episode, Graft Loss or Death Within the First Three Months Post-transplantation | Without Intraoperative Steroids | Total (N= 39, 38) | 26 | Participants | |
| Number of Participants With Biopsy Proven Acute Rejection (BPAR) Episodes Within the First Three Months | With Intraoperative Steroids | 20 | Participants | ||
| Number of Participants With Biopsy Proven Acute Rejection (BPAR) Episodes Within the First Three Months | Without Intraoperative Steroids | 26 | Participants | ||
| Number of Participants With Steroid Resistant Rejection Episodes Within Three and Six Months | With Intraoperative Steroids | Within 3 months post treatment | 2 | Participants | |
| Number of Participants With Steroid Resistant Rejection Episodes Within Three and Six Months | Without Intraoperative Steroids | Within 3 months post treatment | 2 | Participants |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | With Intraoperative Steroids | 39 | |
| Overall Study | STARTED | Without Intraoperative Steroids | 38 | |
| Overall Study | COMPLETED | With Intraoperative Steroids | 26 | |
| Overall Study | COMPLETED | Without Intraoperative Steroids | 20 | |
| Overall Study | NOT COMPLETED | With Intraoperative Steroids | 13 | |
| Overall Study | NOT COMPLETED | Without Intraoperative Steroids | 18 |
Source ClinicalTrials.gov
Adverse events408
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 | Anaemia | Blood and lymphatic system disorders | With Intraoperative Steroids | 17 | 39 | |
| other | Anaemia | Blood and lymphatic system disorders | Without Intraoperative Steroids | 17 | 38 | |
| other | Coagulopathy | Blood and lymphatic system disorders | With Intraoperative Steroids | 2 | 39 | |
| other | Coagulopathy | Blood and lymphatic system disorders | Without Intraoperative Steroids | 6 | 38 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | With Intraoperative Steroids | 3 | 39 | |
| other | Iron deficiency anaemia | Blood and lymphatic system disorders | Without Intraoperative Steroids | 1 | 38 | |
| other | Leukocytosis | Blood and lymphatic system disorders | With Intraoperative Steroids | 2 | 39 | |
| other | Leukocytosis | Blood and lymphatic system disorders | Without Intraoperative Steroids | 6 | 38 | |
| other | Leukopenia | Blood and lymphatic system disorders | With Intraoperative Steroids | 1 | 39 | |
| other | Leukopenia | Blood and lymphatic system disorders | Without Intraoperative Steroids | 4 | 38 |
1 to 10 of 408Source ClinicalTrials.gov
See all 408 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | With Intraoperative Steroids | ||
| Total, all-cause mortality | Without Intraoperative Steroids | ||
| Total, other adverse events | With Intraoperative Steroids | 39 | 39 |
| Total, other adverse events | Without Intraoperative Steroids | 38 | 38 |
| Total, serious adverse events | With Intraoperative Steroids | 18 | 39 |
| Total, serious adverse events | Without Intraoperative Steroids | 23 | 38 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| With Intraoperative Steroids vs Without Intraoperative Steroids: Number of Participants With Biopsy Proven Acute Rejection (BPAR) Episodes Within the First Three Months | Trial comparisons |
| With Intraoperative Steroids vs Without Intraoperative Steroids: serious adverse events | Trial comparisons |
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/NCT00149890
GET https://conductscience.org/api/trials/v1/NCT00149890/results?page=2