Terlipressin for HRS-AKI in Liver Transplant Candidates (INFUSE)
Model scores of the 29,894 trials active now.
Model score 29% for any early termination, 12% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 19% of the time (90 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2023-12-27, after 2020-12-11 start.
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 2023-12-27. 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: transplantmg dlfailureacutegreater
Phrases that lowered it: daysevaluate thetrialscreeninglabel -
Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 3 (lowers risk) · Design
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Trials the sponsor started in the prior 2 years: 138 (lowers risk) · Sponsor's track record
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Sponsor's past termination rate: 8.7% (raises risk) · Sponsor's track record
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Drug's FAERS reports with a death: 37.7% (raises risk) · Drug's FDA history
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Design: single group (raises risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
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Primary purpose: treatment (raises risk) · Design
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Drug's FAERS reports marked serious: 98.1% (raises risk) · Drug's FDA history
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Number of arms: 1 (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Responsible party: sponsor (lowers risk) · Design
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Maximum age: not given (raises risk) · Who can join
-
Sponsor's past trials: 669 (lowers risk) · Sponsor's track record
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Collaborators: 0 (raises risk) · Design
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Has a data monitoring committee: No (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
- 3 (typical: 2)
- Number of arms
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- not given (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 669 (typical: 32)
- Sponsor's past termination rate
- 8.7% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 138 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 1
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 154 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 33 (typical: 412.5)
- Drug's FAERS reports marked serious
- 98.1% (typical: 85.6%)
- Drug's FAERS reports with a death
- 37.7% (typical: 15.9%)
Disease area and drugs
- Disease areas
- digestive, urogenital
- Drugs matched to FDA substances
- terlipressin
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
- A Placebo-Controlled, Double-Blind Study to Confirm the Reversal of Hepatorenal Syndrome Type 1 With Terlipressin NCT01143246 · started 2010 · scored riskier than 87% of active trials completed
- Study To Confirm Efficacy and Safety of Terlipressin in Hepatorenal Syndrome (HRS) Type 1 NCT02770716 · started 2016 · scored riskier than 96% of active trials completed
- A Study for Evaluation of BIV201 to Reduce Ascites and Complications in Patients With Cirrhosis and Refractory Ascites NCT04112199 · started 2021 · scored riskier than 83% of active trials terminated
- Safety and Pharmacokinetics of Ifetroban in Hepatorenal Syndrome Patients NCT01436500 · started 2011 · scored riskier than 85% of active trials completed
- Continuous Infusion Terlipressin for Patients With Cirrhosis and Refractory Ascites NCT03107091 · started 2017 · scored riskier than 74% of active trials completed
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.