IFN-free Combination Therapy in HCV-infected Patients Treatment-naive:HCVerso1
Model scores of the 29,894 trials active now.
Model score 10% 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 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
How it ended
Completed on 2015-01-31, after 2012-12-31 start.
The score above never used this outcome: finished trial that started 2008–2014: scored by a model trained without any trial from its start year, so its own outcome was never used.
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 2015-01-31. 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: patientspriorcarcinomato randomizationserum
Phrases that lowered it: hcvmalescreeningribavirinfemale -
Accepts healthy volunteers: No (raises risk) · Who can join
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Has a data monitoring committee: not given (lowers risk) · Design
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Sponsor's past termination rate: 5.3% (lowers risk) · Sponsor's track record
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Phase: 3 (lowers risk) · Design
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Trials the sponsor started in the prior 2 years: 159 (lowers risk) · Sponsor's track record
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Drug's FAERS reports with a death: 4.7% (lowers risk) · Drug's FDA history
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Drug's FAERS reports marked serious: 60.3% (lowers risk) · Drug's FDA history
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Design: parallel (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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Sponsor's past trials: 152 (lowers risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
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Drug's FAERS reports in the prior 12 months: 12809 (lowers risk) · Drug's FDA history
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Primary purpose: treatment (raises risk) · Design
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Number of arms: 3 (lowers risk) · Design
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Responsible party: sponsor (lowers risk) · Design
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Maximum age: 75 (lowers risk) · Who can join
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
- double (typical: none)
- Has a data monitoring committee
- not given (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 0 (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
- 152 (typical: 32)
- Sponsor's past termination rate
- 5.3% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 159 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 2 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 19976 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 12809 (typical: 412.5)
- Drug's FAERS reports marked serious
- 60.3% (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
- deleobuvir, faldaprevir, ribavirin
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
- Efficacy and Safety of BI 201335 (Faldaprevir) in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-naïve Genotype 1 Hepatitis C Infected Patients (STARTverso 2) NCT01297270 · started 2011 · scored riskier than 12% of active trials completed
- Efficacy and Safety of BI 201335 (Faldaprevir) in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-naïve Genotype 1 Hepatitis C Infected Patients (STARTverso 1) NCT01343888 · started 2011 · scored riskier than 13% of active trials completed
- A Rollover Study of BI 201335 in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-experienced Genotype 1 Hepatitis C Infected Patients NCT01330316 · started 2011 · scored riskier than 11% of active trials completed
- Phase 3 Study of BI 207127 in Combination With Faldaprevir and Ribavirin for Treatment of Patients With Hepatitis C Infection, Including Patients Who Are Not Eligible to Receive Peginterferon: HCVerso2 NCT01728324 · started 2012 · scored riskier than 7% of active trials completed
- Standard of Care (SOC) With or Without CTS-1027 in Hepatitis C (HCV) Null-Responders NCT01273064 · started 2011 · scored riskier than 49% 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.