Hydroxyurea Therapy: Optimizing Access in Pediatric Populations Everywhere
Model scores of the 29,894 trials active now.
Model score 13% for any early termination, 12% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 30% of the time (107 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2022-01-20, after 2019-06-10 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 2022-01-20. 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
-
Design: crossover (lowers risk) · Design
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Sponsor's past termination rate: 15.7% (raises risk) · Sponsor's track record
-
Phase: 2 (raises risk) · Design
-
Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: sickleinfantsanemiato determinecell
Phrases that lowered it: participantparticipantscountpharmacokineticsof normal -
Has a data monitoring committee: Yes (raises risk) · Design
-
Disease area, cancer: No (lowers risk) · Disease area
-
Sponsor type: academic or other (raises risk) · Sponsor's track record
-
Drug's FAERS reports with a death: 18.4% (lowers risk) · Drug's FDA history
-
Minimum age: 0.75 (lowers risk) · Who can join
-
Primary purpose: treatment (raises risk) · Design
-
Drug's FAERS reports marked serious: 80.5% (lowers risk) · Drug's FDA history
-
Maximum age: 18 (raises risk) · Who can join
-
Blinding: none (raises risk) · Design
-
Collaborators: 0 (raises risk) · Design
-
Disease area, neurology: No (lowers risk) · Disease area
-
Trials the sponsor started in the prior 2 years: 14 (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
- 2
- Number of arms
- 2
- Allocation
- randomized
- Design
- crossover (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 0.75 (typical: 18)
- Maximum age
- 18 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- academic or other
- Sponsor's past trials
- 121 (typical: 32)
- Sponsor's past termination rate
- 15.7% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 14 (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
- 10587 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 1929 (typical: 412.5)
- Drug's FAERS reports marked serious
- 80.5% (typical: 85.6%)
- Drug's FAERS reports with a death
- 18.4% (typical: 15.9%)
Disease area and drugs
- Disease areas
- hematology
- Drugs matched to FDA substances
- hydroxyurea
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
- Pharmacokinetics (PK) of Liquid Hydroxyurea in Pediatric Patients With Sickle Cell Anemia NCT01506544 · started 2011 · scored riskier than 23% of active trials completed
- Pharmacokinetics of Oral Hydroxyurea Solution NCT03763656 · started 2019 · scored riskier than 28% of active trials completed
- A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of Oral GSK4172239D Compared With Placebo in Sickle Cell Disease Participants Aged 18 to 50 Years NCT05660265 · started 2023 · scored riskier than 16% of active trials terminated
- Hydroxyurea Management in Kids: Intensive Versus Stable Dosage Strategies NCT03020615 · started 2017 · scored riskier than 75% of active trials completed
- Safety, Tolerability and Pharmacokinetics of FTX-6058 NCT04586985 · started 2020 · scored riskier than 8% 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.