Study to Assess the Pharmacokinetics of Pelacarsen (TQJ230) in Participants With Mild Hepatic Impairment Compared to Matched Healthy Participants
Model scores of the 29,894 trials active now.
Model score 8% for any early termination, 1% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 5% of the time (4,470 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2022-10-19, after 2021-11-23 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 2022-10-19. 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) (lowers risk) · Wording
Phrases that raised it: treatmentpriorbaselinemonthsdefined
Phrases that lowered it: participantparticipantshealthymildexamination -
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 15.2% (raises risk) · Sponsor's track record
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Primary purpose: other (lowers risk) · Design
-
Phase: 1 (lowers risk) · Design
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Sponsor's past trials: 1413 (raises risk) · Sponsor's track record
-
Has a data monitoring committee: not given (lowers risk) · Design
-
Design: parallel (raises risk) · Design
-
Trials the sponsor started in the prior 2 years: 154 (lowers risk) · Sponsor's track record
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Drug's FAERS reports with a death: 0% (lowers risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
-
Drug's FAERS reports marked serious: 100% (raises risk) · Drug's FDA history
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
-
Disease area, neurology: No (lowers risk) · Disease area
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
- 1 (typical: 2)
- Number of arms
- 2
- Allocation
- non randomized (typical: randomized)
- Design
- parallel
- Primary purpose
- other (typical: treatment)
- Blinding
- none
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 4 (typical: 1)
Who can join
- Minimum age
- 18
- Maximum age
- 75 (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
- 1413 (typical: 32)
- Sponsor's past termination rate
- 15.2% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 154 (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
- 2 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 2 (typical: 412.5)
- Drug's FAERS reports marked serious
- 100% (typical: 85.6%)
- Drug's FAERS reports with a death
- 0% (typical: 15.9%)
Disease area and drugs
- Disease areas
- none of the 14 tracked areas
- Drugs matched to FDA substances
- pelacarsen
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 Study to Investigate the Pharmacokinetics and Safety of Remibrutinib in Participants With Hepatic Impairment Compared With Matched Healthy Participants NCT05753592 · started 2022 · scored riskier than 3% of active trials completed
- A Study to Assess the Phamacokinetics of BV100 in Participants with Varying Degrees of Hepatic Impairment NCT05537142 · started 2022 · scored riskier than 4% of active trials completed
- Study of Hydroxynidone Capsules in Patients With Hepatic Impairment and Matched Healthy Controls NCT07394309 · started 2026 · scored riskier than 2% of active trials completed
- A Study of Camlipixant in Male and Female Healthy Participants and Participants With Hepatic Impairment Aged 18-75 Years of Age NCT06222892 · started 2024 · scored riskier than 3% of active trials completed
- A Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of KP-001 NCT06619054 · started 2024 · scored riskier than 2% 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.