The Effectiveness of L-ornithine-L-aspartate (LOLA) on Plasma Ammonia in Cirrhotic Patients After TIPS
Model scores of the 29,894 trials active now.
Model score 16% for any early termination, 7% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 10% of the time (30 trials).
Finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
How it ended
Completed on 2012-12-31, after 2011-12-31 start.
The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
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 2012-12-31. 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: refractorymalignancyorgan18 yearsliver
Phrases that lowered it: plasmathe aimaim oflabelevaluate the -
Accepts healthy volunteers: No (raises risk) · Who can join
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Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
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Phase: 2/3 (raises risk) · Design
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Sponsor type: academic or other (raises risk) · Sponsor's track record
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Design: parallel (raises risk) · Design
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Drug's FAERS reports with a death: 18.4% (lowers risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
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Responsible party: principal investigator (lowers risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Number of arms: 2 (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Trials the sponsor started in the prior 2 years: 4 (raises risk) · Sponsor's track record
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Maximum age: 65 (lowers risk) · Who can join
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Drug's FAERS reports marked serious: 89.3% (raises risk) · Drug's FDA history
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Collaborators: 0 (raises risk) · Design
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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
- 2/3 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- principal investigator (typical: sponsor)
- Collaborators
- 0
- Keywords listed
- 6 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 65 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 0 (typical: 32)
- Sponsor's past termination rate
- no earlier finished trials (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 4 (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
- 206 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 39 (typical: 412.5)
- Drug's FAERS reports marked serious
- 89.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 18.4% (typical: 15.9%)
Disease area and drugs
- Disease areas
- digestive
- Drugs matched to FDA substances
- aspartate, ornithine
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
- Phase 2B Efficacy/Safety of Ornithine Phenylacetate in Hospitalized Cirrhotic Patients With Hepatic Encephalopathy (STOP-HE) NCT01966419 · started 2014 · scored riskier than 47% of active trials completed
- Effects of the Administration of Ornithine Phenylacetate in Patients With Cirrhosis and Upper Gastrointestinal Bleeding NCT01434108 · started 2011 · scored riskier than 17% of active trials completed
- Rifaximin vs Placebo for the Prevention of Encephalopathy in Patients Treated by TIPS NCT02016196 · started 2013 · scored riskier than 87% of active trials completed
- Deprescribing Proton Pump Inhibitors to Reduce Post-TIPS Hepatic Encephalopathy NCT05070351 · started 2022 · scored riskier than 73% of active trials completed
- Randomized Controlled Trial to Assess the Effects of Sapropterin on Hepatic and Systemic Hemodynamics in Patients With Liver Cirrhosis and Portal Hypertension NCT01456286 · started 2011 · scored riskier than 66% 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.