Trial · NCT03781414
Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Liver Transplant Recipients With Additional 12-month Follow-up and Long-term Extension
NCT03781414, Phase 2, Terminated, Novartis Pharmaceuticals; results first posted 2024-07-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Liver Transplant Recipients With Additional 12-month Follow-up and Long-term Extension. Trials, record NCT03781414. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03781414
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Liver Transplant Recipients With Additional 12-month Follow-up and Long-term Extension
- NCT number
- NCT03781414
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 129 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Liver Transplant Rejection
- Interventions
- CFZ533, Tacrolimus - MMF - corticosteroids
- First posted
- 2018-12-19
- Last updated
- 2025-05-16
- Other registries' IDs
- eudract:2018-001836-24
- Results first posted
- 2024-07-03
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Patients With Composite Event (Biopsy Proven Acute Rejection (BPAR), Graft Loss or Death) Over 12 Months | Baseline to Month 12 | The occurrence of biopsy proven acute rejection (BPAR) was evaluated based on central pathologist evaluation. Graft loss and death was evaluated as per local evaluation. |
| Secondary | Mean Change in Estimated Glomerular Filtration Rate (eGFR) From Randomization to Month 12 | Baseline to Month 12 | Renal function as measured by estimated Glomerular Filtration Rate (eGFR) was evaluated using the MDRD formula: eGFR = 175 x (serum concentration of creatinine (SCr))-1.154 x (age)-0.203 x 0.742 \[if female\] x 1.212 \[if Black\]. |
| Secondary | Number of Participants With Treatment Emergent Adverse Events | Baseline up to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. | The distribution of adverse events was done via the analysis of frequencies for treatment emergent Adverse Event (TEAEs), Serious Adverse Event (TESAEs), Deaths due to AEs and TEAEs leading to discontinuation, through the monitoring of relevant clinical and laboratory safety parameters. |
| Secondary | Percentage of Patients With Dose Interruptions and Permanent Discontinuation of Study Treatment | Baseline to Month 24 | The number and percentage of participants with dose changes (MMF and TAC), dose interruptions (only in cases of ascites drainage), and permanent discontinuation was summarized. In the CFZ533 arms, during the immediate peri and post-transplant period, TAC was given to provide immunological coverage but TAC needed to be completely weaned off by Day 22. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Patients With Composite Event (Biopsy Proven Acute Rejection (BPAR), Graft Loss or Death) Over 12 Months | Baseline to Month 12 | Full Analysis Set (FAS) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Change in Estimated Glomerular Filtration Rate (eGFR) From Randomization to Month 12 | Baseline to Month 12 | Full Analysis Set (FAS) | mL/min/1.73 m^2 | MEAN |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Events | Baseline up to 14 weeks after last dose of study medication (CFZ533 participants) and until 12 weeks for TAC participants, up to approx. 184 weeks. | Safety Set (SAF) | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Patients With Dose Interruptions and Permanent Discontinuation of Study Treatment | Baseline to Month 24 | Safety Set (SAF) | Participants | COUNT_OF_PARTICIPANTS |
| POST_HOC | All Collected Deaths | On-treatment deaths: Up to approximately 184 weeks. Post-treatment deaths: Up to approximately 184 weeks. | Safety Set (SAF) | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group43
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Patients With Composite Event (Biopsy Proven Acute Rejection (BPAR), Graft Loss or Death) Over 12 Months | CFZ533 300 mg Regimen (CFZ533 300 mg + MMF) | 8 | Participants | ||
| Percentage of Patients With Composite Event (Biopsy Proven Acute Rejection (BPAR), Graft Loss or Death) Over 12 Months | CFZ533 600 mg Regimen (CFZ533 600 mg + MMF) | 12 | Participants | ||
| Percentage of Patients With Composite Event (Biopsy Proven Acute Rejection (BPAR), Graft Loss or Death) Over 12 Months | TAC Control (TAC + MMF) | 3 | Participants | ||
| Mean Change in Estimated Glomerular Filtration Rate (eGFR) From Randomization to Month 12 | CFZ533 300 mg Regimen (CFZ533 300 mg + MMF) | 2.05 | Full Range -60.4 to 71.5 | mL/min/1.73 m^2 | |
| Mean Change in Estimated Glomerular Filtration Rate (eGFR) From Randomization to Month 12 | CFZ533 600 mg Regimen (CFZ533 600 mg + MMF) | -9.31 | Full Range -55.8 to 28.7 | mL/min/1.73 m^2 | |
| Mean Change in Estimated Glomerular Filtration Rate (eGFR) From Randomization to Month 12 | TAC Control (TAC + MMF) | -14.74 | Full Range -104.0 to 20.6 | mL/min/1.73 m^2 | |
| Number of Participants With Treatment Emergent Adverse Events | CFZ533 300 mg Regimen (CFZ533 300 mg + MMF) | TEAEs | 48 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events | CFZ533 600 mg Regimen (CFZ533 600 mg + MMF) | TEAEs | 44 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events | TAC Control (TAC + MMF) | TEAEs | 32 | Participants | |
| Number of Participants With Treatment Emergent Adverse Events | CFZ533 300 mg Regimen (CFZ533 300 mg + MMF) | TESAEs | 30 | Participants |
1 to 10 of 43Source ClinicalTrials.gov
See all 43 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | CFZ533 300 mg Regimen (CFZ533 300 mg + MMF) | 48 | |
| Overall Study | STARTED | CFZ533 600 mg Regimen (CFZ533 600 mg + MMF) | 48 | |
| Overall Study | STARTED | TAC Control (TAC + MMF) | 32 | |
| Overall Study | Safety Set (SAF) | CFZ533 300 mg Regimen (CFZ533 300 mg + MMF) | 48 | |
| Overall Study | Safety Set (SAF) | CFZ533 600 mg Regimen (CFZ533 600 mg + MMF) | 47 | |
| Overall Study | Safety Set (SAF) | TAC Control (TAC + MMF) | 32 | |
| Overall Study | COMPLETED | CFZ533 300 mg Regimen (CFZ533 300 mg + MMF) | 0 | |
| Overall Study | COMPLETED | CFZ533 600 mg Regimen (CFZ533 600 mg + MMF) | 0 | |
| Overall Study | COMPLETED | TAC Control (TAC + MMF) | 0 | |
| Overall Study | NOT COMPLETED | CFZ533 300 mg Regimen (CFZ533 300 mg + MMF) | 48 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events1,296
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 | CFZ533 300 mg Regimen (CFZ533 300 mg + MMF) (On-Treatment) | 4 | 48 | |
| other | Anaemia | Blood and lymphatic system disorders | CFZ533 600 mg Regimen (CFZ533 600 mg + MMF) (On-Treatment) | 5 | 47 | |
| other | Anaemia | Blood and lymphatic system disorders | TAC Control (TAC + MMF) (On-Treatment) | 4 | 32 | |
| other | Anaemia | Blood and lymphatic system disorders | CFZ533 300 mg Regimen (CFZ533 300 mg + MMF) (Post-Treatment) | 0 | ||
| other | Anaemia | Blood and lymphatic system disorders | CFZ533 600 mg Regimen (CFZ533 600 mg + MMF) (Post-Treatment) | 0 | ||
| other | Anaemia | Blood and lymphatic system disorders | TAC Control (TAC + MMF) (Post-Treatment) | 0 | ||
| other | Leukopenia | Blood and lymphatic system disorders | CFZ533 300 mg Regimen (CFZ533 300 mg + MMF) (On-Treatment) | 17 | 48 | |
| other | Leukopenia | Blood and lymphatic system disorders | CFZ533 600 mg Regimen (CFZ533 600 mg + MMF) (On-Treatment) | 16 | 47 | |
| other | Leukopenia | Blood and lymphatic system disorders | TAC Control (TAC + MMF) (On-Treatment) | 9 | 32 | |
| other | Leukopenia | Blood and lymphatic system disorders | CFZ533 300 mg Regimen (CFZ533 300 mg + MMF) (Post-Treatment) | 0 |
1 to 10 of 1,296Source ClinicalTrials.gov
See all 1,296 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | CFZ533 300 mg Regimen (CFZ533 300 mg + MMF) (On-Treatment) | 1 | 48 |
| Total, all-cause mortality | CFZ533 600 mg Regimen (CFZ533 600 mg + MMF) (On-Treatment) | 3 | 47 |
| Total, all-cause mortality | TAC Control (TAC + MMF) (On-Treatment) | 0 | 32 |
| Total, all-cause mortality | CFZ533 300 mg Regimen (CFZ533 300 mg + MMF) (Post-Treatment) | 0 | 47 |
| Total, all-cause mortality | CFZ533 600 mg Regimen (CFZ533 600 mg + MMF) (Post-Treatment) | 1 | 44 |
| Total, all-cause mortality | TAC Control (TAC + MMF) (Post-Treatment) | 0 | 32 |
| Total, other adverse events | CFZ533 300 mg Regimen (CFZ533 300 mg + MMF) (On-Treatment) | 45 | 48 |
| Total, other adverse events | CFZ533 600 mg Regimen (CFZ533 600 mg + MMF) (On-Treatment) | 42 | 47 |
| Total, other adverse events | TAC Control (TAC + MMF) (On-Treatment) | 30 | 32 |
| Total, other adverse events | CFZ533 300 mg Regimen (CFZ533 300 mg + MMF) (Post-Treatment) | 0 | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers0
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 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/NCT03781414
GET https://conductscience.org/api/trials/v1/NCT03781414/results?page=2