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
Model scores of the 29,894 trials active now.
Model score 23% for any early termination, 5% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 13% of the time (1,304 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2023-04-20, after 2019-10-07 start.
Reason given by the sponsor: “efficacy”
The score above never used this outcome: finished trial that started in 2015 or later: the model never saw it during training.
Termination over time, as the model saw it at the start
Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2023-04-20. The rest of the way to 100% is still running.
From the competing-risks survival model (termination vs completion, still-running trials censored), fit to trials that started 2008–2014 and recalibrated to termination rates over 2022–2024, since termination has become more common. Checked on past years, it still ran a little low when the rise continued.
What moved the score
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: donortransplantationtransplantcelltherapy
Phrases that lowered it: screeningperiodpharmacokineticshcvpharmacokinetic -
Accepts healthy volunteers: No (raises risk) · Who can join
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Sponsor's past termination rate: 15% (raises risk) · Sponsor's track record
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Phase: 2 (raises risk) · Design
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Sponsor's past trials: 1260 (raises risk) · Sponsor's track record
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Trials the sponsor started in the prior 2 years: 153 (lowers risk) · Sponsor's track record
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Design: parallel (raises risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
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Number of arms: 3 (lowers risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Drug's FAERS reports with a death: 19.1% (lowers risk) · Drug's FDA history
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Drug's FAERS reports in the prior 12 months: 12559 (lowers risk) · Drug's FDA history
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Drug's FAERS reports before start: 74291 (lowers risk) · Drug's FDA history
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Collaborators: 0 (raises risk) · Design
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Drug's FAERS reports marked serious: 89.7% (raises risk) · Drug's FDA history
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Keywords listed: 6 (lowers risk) · Design
Every input that moved this score, largest first: SHAP contributions in log-odds, red raising risk and green lowering it. They describe the model, not causes of termination. Phrases are traced from the text features back to this registration's words, approximately.
The trial
Design
- Phase
- 2
- Number of arms
- 3 (typical: 2)
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 6 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 70 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- industry (typical: academic or other)
- Sponsor's past trials
- 1260 (typical: 32)
- Sponsor's past termination rate
- 15% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 153 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 74291 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 12559 (typical: 412.5)
- Drug's FAERS reports marked serious
- 89.7% (typical: 85.6%)
- Drug's FAERS reports with a death
- 19.1% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- iscalimab, tacrolimus
Typical values are among the trials active now. Sponsor and drug history are counted only up to this trial's start date.
Similar finished trials
- Efficacy and Safety of Concentration-controlled Everolimus to Eliminate or to Reduce Tacrolimus Compared to Tacrolimus in de Novo Liver Transplant Recipients NCT00622869 · started 2008 · scored riskier than 55% of active trials completed
- Efficacy of Sofosbuvir With Ribavirin Administered Pre-Transplant in Preventing Hepatitis C Virus (HCV) Recurrence Post-Transplant NCT01559844 · started 2012 · scored riskier than 33% of active trials completed
- Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Kidney Transplant Recipients NCT03663335 · started 2018 · scored riskier than 80% of active trials completed
- Delayed Infusion of DCreg in Living Donor Liver Transplantation NCT04208919 · started 2019 · scored riskier than 94% of active trials completed
- Early Treatment With Sofosbuvir (SOF) and Ledipasvir (LDV) to Prevent HCV Recurrence After Liver Transplantation (OLT) NCT02478229 · started 2015 · scored riskier than 42% of active trials terminated
Closest by meaning of the registration text (PubMedBERT embeddings), among finished trials. How they ended is context, not an input to this trial's score.