Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Participants With Chronic Genotype 2 HCV Infection
Model scores of the 29,894 trials active now.
Model score 4% 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 6% of the time (876 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2017-05-11, after 2016-04-12 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 2017-05-11. 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: tolerabilitykeytherapychronicinfection
Phrases that lowered it: participantsgenotypeevaluate theefficacy andand safety -
Minimum age: 20 (lowers risk) · Who can join
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Accepts healthy volunteers: No (raises risk) · Who can join
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Phase: 3 (lowers risk) · Design
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Drug's FAERS reports marked serious: 52.3% (lowers risk) · Drug's FDA history
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Drug's FAERS reports with a death: 4.7% (lowers risk) · Drug's FDA history
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Sponsor's past termination rate: 10.4% (raises risk) · Sponsor's track record
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Disease area, cancer: No (lowers risk) · Disease area
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Trials the sponsor started in the prior 2 years: 109 (lowers risk) · Sponsor's track record
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Design: parallel (raises risk) · Design
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Has a data monitoring committee: No (lowers risk) · Design
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Number of arms: 3 (lowers risk) · Design
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Drug's FAERS reports in the prior 12 months: 36234 (lowers risk) · Drug's FDA history
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Primary purpose: treatment (raises risk) · Design
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Drug's FAERS reports before start: 81197 (lowers risk) · Drug's FDA history
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Disease area, neurology: No (lowers risk) · Disease area
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Blinding: none (lowers risk) · Design
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Sponsor's past trials: 270 (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
- 3 (typical: 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
- 0 (typical: 1)
Who can join
- Minimum age
- 20 (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
- 270 (typical: 32)
- Sponsor's past termination rate
- 10.4% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 109 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 3 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 81197 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 36234 (typical: 412.5)
- Drug's FAERS reports marked serious
- 52.3% (typical: 85.6%)
- Drug's FAERS reports with a death
- 4.7% (typical: 15.9%)
Disease area and drugs
- Disease areas
- infectious disease, digestive
- Drugs matched to FDA substances
- ledipasvir sofosbuvir, ribavirin, sofosbuvir
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
- Safety and Efficacy of Ledipasvir/Sofosbuvir (LDV/SOF) Fixed Dose Combination Tablet With Ribavirin for 12 Weeks in Treatment-naive Adults With Chronic HCV Genotype 3 Infection NCT02413593 · started 2015 · scored riskier than 8% of active trials completed
- Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Participants With Chronic Genotype 1 HCV Infection NCT02021656 · started 2013 · scored riskier than 7% of active trials completed
- Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Treatment-Naive and Treatment-Experienced Subjects With Chronic Genotype 4 or 5 HCV Infection NCT02081079 · started 2014 · scored riskier than 12% of active trials completed
- Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 1 or 4 HCV and HIV-1 Co-infection NCT02073656 · started 2014 · scored riskier than 8% of active trials completed
- Safety and Efficacy of Ledipasvir/Sofosbuvir in Adults With Chronic HCV Infection NCT02472886 · started 2015 · 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.