GBT021601-022: A Study of GBT021601 in Participants With Sickle Cell Disease (SCD)
Model scores of the 29,894 trials active now.
Model score 22% for any early termination, 1% for termination due to slow enrollment. Past trials like this one (phase and sponsor type, started 2008–2016) ended terminated 16% of the time (370 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2025-02-13, after 2023-01-05 start.
Reason given by the sponsor: “safety”
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 2025-02-13. 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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Sponsor's past termination rate: 15.9% (raises risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
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Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: extension studysicklelast doselong termchildbearing potential
Phrases that lowered it: participantevaluate thesafety ofto evaluateopen label -
Sponsor's past trials: 2123 (raises risk) · Sponsor's track record
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Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
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Has a data monitoring committee: No (lowers risk) · Design
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Design: single group (raises risk) · Design
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Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 181 (lowers risk) · Sponsor's track record
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Phase: 2/3 (raises risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Disease area, neurology: No (lowers risk) · Disease area
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Drug's FAERS reports before start: 0 (raises risk) · Drug's FDA history
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Maximum age: not given (raises risk) · Who can join
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Drug's FAERS reports in the prior 12 months: 0 (raises risk) · Drug's FDA history
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
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (typical: 1)
Who can join
- Minimum age
- 0.5 (typical: 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
- 2123 (typical: 32)
- Sponsor's past termination rate
- 15.9% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 181 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 0 (typical: 1)
- Drug has FAERS history
- No (typical: 64% yes)
- Drug's FAERS reports before start
- 0 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 0 (typical: 412.5)
- Drug's FAERS reports marked serious
- no FAERS history (typical: 85.6%)
- Drug's FAERS reports with a death
- no FAERS history (typical: 15.9%)
Disease area and drugs
- Disease areas
- hematology
- Drugs matched to FDA substances
- none matched
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
- An Extension Study to Further Evaluate the Safety, Tolerability of GBT440 in Patients With Sickle Cell Disease Who Participated in the Study GBT440-001 NCT03041909 · started 2016 · scored riskier than 31% 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
- Extension Study to Evaluate the Safety and Efficacy of Luspatercept in Participants With β-Thalassemia Previously Enrolled in A536-04 (A536-06/MK-6143-004) NCT02268409 · started 2014 · scored riskier than 67% of active trials completed
- Safety, Tolerability and Pharmacokinetics of FTX-6058 NCT04586985 · started 2020 · scored riskier than 8% of active trials completed
- A Study to Evaluate the Long-term Safety of Inclacumab Administered to Participants With Sickle Cell Disease NCT05348915 · started 2022 · scored riskier than 74% of active trials terminated
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.