Study to Evaluate the Efficacy and Safety of Deferasirox Film-coated Tablet Versus Phlebotomy in Patients With Hereditary Hemochromatosis (HH)
Model scores of the 29,894 trials active now.
Model score 23% for any early termination, 9% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 11% of the time (493 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2023-04-17, after 2018-01-11 start.
Reason given by the sponsor: “enrollment”
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 2023-04-17. 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: carcinomaironhepatitisgenotypecardiac
Phrases that lowered it: visitand safetyevaluate theto evaluatetablet -
Sponsor's past termination rate: 14.7% (raises risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 2 (raises risk) · Design
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Design: parallel (raises risk) · Design
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Sponsor's past trials: 1070 (raises risk) · Sponsor's track record
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Drug's FAERS reports with a death: 33.1% (raises risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 174 (lowers risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Primary purpose: treatment (raises risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Has a data monitoring committee: No (lowers risk) · Design
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Disease area, metabolic: Yes (lowers risk) · Disease area
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Drug's FAERS reports marked serious: 89.4% (raises risk) · Drug's FDA history
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Responsible party: sponsor (lowers risk) · Design
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Collaborators: 0 (raises 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
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 4 (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
- industry (typical: academic or other)
- Sponsor's past trials
- 1070 (typical: 32)
- Sponsor's past termination rate
- 14.7% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 174 (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
- 19626 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1428 (typical: 412.5)
- Drug's FAERS reports marked serious
- 89.4% (typical: 85.6%)
- Drug's FAERS reports with a death
- 33.1% (typical: 15.9%)
Disease area and drugs
- Disease areas
- metabolic
- Drugs matched to FDA substances
- deferasirox
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
- Open-label, Multicenter Study Assessing Preference for Deferasirox Film-coated Tablet Compared to Dispersible Tablet NCT02993224 · started 2017 · scored riskier than 63% of active trials completed
- Deferasirox in Treating Patients With Very Low, Low, or Intermediate-Risk Red Blood Cell Transfusion Dependent Anemia or Myelodysplastic Syndrome NCT02943668 · started 2017 · scored riskier than 72% of active trials terminated
- Safety of SP-420 in the Treatment of Transfusional Iron Overload NCT04741542 · started 2021 · scored riskier than 38% of active trials terminated
- Pilot Study to Assess the Safety, PK and Iron Chelating Activity of DST-0509 (Deferasirox) in Thalassemia Patients Refractory to Chelation NCT03637556 · started 2019 · scored riskier than 63% of active trials completed
- Study of DISC-0974 to Assess the Safety, Tolerability, PK and PD of DISC-0974 in Participants With CKD and Anemia NCT05745883 · started 2023 · scored riskier than 58% 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.