A Trial to Improve Quality of Life in People With Cirrhosis
Model scores of the 29,894 trials active now.
Model score 17% for any early termination, 8% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 16% of the time (112 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2022-11-01, after 2021-11-10 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 2022-11-01. 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: mrictlifeimprovemalignancy
Phrases that lowered it: trialevaluatehepaticindexhistory -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 12.2% (raises risk) · Sponsor's track record
-
Has a data monitoring committee: not given (lowers risk) · Design
-
Trials the sponsor started in the prior 2 years: 119 (lowers risk) · Sponsor's track record
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Drug's FAERS reports with a death: 18.7% (lowers risk) · Drug's FDA history
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Design: parallel (raises risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Disease area, neurology: Yes (raises risk) · Disease area
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Primary purpose: treatment (raises risk) · Design
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Phase: 2/3 (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
-
Disease area, cancer: No (lowers risk) · Disease area
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Responsible party: principal investigator (lowers risk) · Design
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Sponsor's past trials: 681 (raises risk) · Sponsor's track record
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Collaborators: 0 (raises risk) · Design
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Drug's FAERS reports marked serious: 89.3% (raises risk) · Drug's FDA history
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
- 2/3 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 3 (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
- 681 (typical: 32)
- Sponsor's past termination rate
- 12.2% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 119 (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
- 31207 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 3471 (typical: 412.5)
- Drug's FAERS reports marked serious
- 89.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 18.7% (typical: 15.9%)
Disease area and drugs
- Disease areas
- neurology, digestive, metabolic
- Drugs matched to FDA substances
- lactulose
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
- Effect of Probiotics in Treatment of Minimal Hepatic Encephalopathy (MHE) and Health Related Quality of Life NCT01008293 · started 2009 · scored riskier than 16% of active trials completed
- Comparison Between Lactulose and Lactulose-Paraffin in Cirrhotic Patients NCT02017119 · started 2011 · scored riskier than 20% of active trials completed
- Effect of Tolvaptan on Cognitive Function in Cirrhosis NCT01556646 · started 2011 · scored riskier than 78% of active trials completed
- LiveSMART Trial to Prevent Falls in Patients With Cirrhosis NCT05794555 · started 2023 · scored riskier than 43% of active trials completed
- PK Profile and Preliminary Efficacy of TNP-2092 Capsules in Liver Cirrhosis Patients With Hyperammonemia NCT06135675 · started 2020 · scored riskier than 6% 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.