Evaluating the Safety and Effectiveness of Interferon-Free Treatment of Hepatitis C Virus Infection in HIV-Coinfected Adults on Antiretroviral Therapy
Model scores of the 29,894 trials active now.
Model score 13% for any early termination, 4% 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 (122 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2018-11-13, after 2015-09-16 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 2018-11-13. 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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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: or equalequal todlgreatercell
Phrases that lowered it: participantsparticipantinfectedantiretroviralbmi -
Phase: 2 (raises risk) · Design
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Sponsor's past termination rate: 5.9% (lowers risk) · Sponsor's track record
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Trials the sponsor started in the prior 2 years: 99 (lowers risk) · Sponsor's track record
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Drug's FAERS reports marked serious: 59.4% (lowers risk) · Drug's FDA history
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Design: parallel (raises risk) · Design
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Has a data monitoring committee: Yes (raises risk) · Design
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Drug's FAERS reports with a death: 4.6% (lowers risk) · Drug's FDA history
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Disease area, cancer: No (lowers risk) · Disease area
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Number of arms: 4 (lowers risk) · Design
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Minimum age: 18 (raises risk) · Who can join
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Primary purpose: treatment (raises risk) · Design
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Collaborators: 0 (raises risk) · Design
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Responsible party: sponsor (lowers risk) · Design
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Maximum age: 70 (lowers risk) · Who can join
-
Blinding: none (lowers risk) · Design
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
- 4 (typical: 2)
- Allocation
- non randomized (typical: randomized)
- Design
- 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
- 18
- Maximum age
- 70 (typical: 71)
- Sex
- all
- Accepts healthy volunteers
- No (typical: 9% yes)
Sponsor's track record
- Sponsor type
- government (typical: academic or other)
- Sponsor's past trials
- 1055 (typical: 32)
- Sponsor's past termination rate
- 5.9% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 99 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 4 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 46767 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 11920 (typical: 412.5)
- Drug's FAERS reports marked serious
- 59.4% (typical: 85.6%)
- Drug's FAERS reports with a death
- 4.6% (typical: 15.9%)
Disease area and drugs
- Disease areas
- infectious disease, digestive, immunology, urogenital
- Drugs matched to FDA substances
- dasabuvir, ombitasvir, paritaprevir, paritaprevir ritonavir, 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
- Evaluating the Effectiveness of Boceprevir, Pegylated-Interferon Alfa 2b and Ribavirin in Treating Hepatitis C Virus (HCV) Infection in Adults With HIV and HCV Infection NCT01482767 · started 2012 · scored riskier than 23% of active trials completed
- Nitazoxanide Plus Ribavirin and Peginterferon for Therapy of Treatment Naive HCV Genotype 1 and HIV Coinfected Subjects NCT00991289 · started 2010 · scored riskier than 49% of active trials completed
- Study of A Combination Pill With GS-7977 and GS-5885 for Hepatitis C in People With HIV NCT01878799 · started 2013 · scored riskier than 48% of active trials completed
- Safety, Tolerability, and Efficacy of Asunaprevir and Daclatasvir in Subjects Coinfected With HIV-HCV NCT02124044 · started 2014 · scored riskier than 41% of active trials completed
- Randomised Study of Interferon-free Treatment for Recently Acquired Hepatitis C in PWID and People With HIV Coinfection. NCT02625909 · started 2017 · scored riskier than 36% 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.