Norfloxacin Therapy for Patients With Cirrhosis and Severe Liver Failure
Model scores of the 29,894 trials active now.
Model score 22% for any early termination, 11% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 14% of the time (741 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
Terminated on 2015-11-30, after 2010-04-30 start.
Reason given by the sponsor: “enrollment”
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 2015-11-30. 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: cirrhosispatientto assessfailureplacebo controlled
Phrases that lowered it: oral administrationinflammatoryadministration ofparticipatewith severe -
Sponsor's past termination rate: 21.0% (raises risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 3 (lowers risk) · Design
-
Blinding: triple (raises risk) · Design
-
Design: parallel (raises risk) · Design
-
Primary purpose: prevention (lowers risk) · Design
-
Trials the sponsor started in the prior 2 years: 151 (lowers risk) · Sponsor's track record
-
Has a data monitoring committee: Yes (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 98.3% (raises risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
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Drug's FAERS reports with a death: 20.7% (raises risk) · Drug's FDA history
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Sponsor's past trials: 124 (lowers risk) · Sponsor's track record
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
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- prevention (typical: treatment)
- Blinding
- triple (typical: none)
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 2 (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
- 124 (typical: 32)
- Sponsor's past termination rate
- 21.0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 151 (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
- 241 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 44 (typical: 412.5)
- Drug's FAERS reports marked serious
- 98.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 20.7% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- norfloxacin
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
- Rifaximin and Norfloxacin for Prevention of SBP in Adults With Decompensated Cirrhosis NCT03695705 · started 2016 · scored riskier than 26% of active trials completed
- Primary Prophylaxis for Spontaneous Bacterial Peritonitis NCT04775329 · started 2020 · scored riskier than 48% of active trials terminated
- Efficacy of the Combination of Simvastatin Plus Rifaximin in Patients With Decompensated Cirrhosis to Prevent ACLF Development NCT03780673 · started 2019 · scored riskier than 68% of active trials completed
- Simvastatin Plus Rifaximin in Decompensated Cirrhosis NCT03150459 · started 2017 · scored riskier than 78% of active trials completed
- Rifaximin Prophylaxis for Spontaneous Bacterial Peritonitis and Hepatorenal Syndrome in Cirrhotic Patients NCT05621005 · started 2019 · scored riskier than 59% 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.