A Study Comparing The Effects Of Epoetin Hospira Single-Dose Vial (SDV) And Multi-Dose Vial (MDV) When Administered Subcutaneously To Normal Healthy Subjects

NCT03398473 on ClinicalTrials.gov Phase 1 Pfizer (industry) Started 2018-01-25 Completed

Riskier than 3% of active trials

Model scores of the 29,894 trials active now.

Model score 4% for any early termination, 0% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 5% of the time (4,470 trials).

Finished trial that started in 2015 or later: the model never saw it during training.

How it ended

Completed on 2018-05-07, after 2018-01-25 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 2018-05-07. 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

Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: to determinemultipledetermine thefailureovarian
Phrases that lowered it: healthymmhgsingle dosesubjects whopharmacokinetics
Accepts healthy volunteers: Yes (lowers risk) · Who can join
Design: crossover (lowers risk) · Design
Sponsor's past termination rate: 16.1% (raises risk) · Sponsor's track record
Phase: 1 (lowers risk) · Design
Sponsor's past trials: 1710 (raises risk) · Sponsor's track record
Has a data monitoring committee: No (lowers risk) · Design
Trials the sponsor started in the prior 2 years: 145 (lowers risk) · Sponsor's track record
Sponsor type: industry (lowers risk) · Sponsor's track record
Blinding: none (lowers risk) · Design
Drug's FAERS reports with a death: 23.6% (raises risk) · Drug's FDA history
Disease area, cancer: No (lowers risk) · Disease area
Drug's FAERS reports marked serious: 74.3% (lowers risk) · Drug's FDA history
Minimum age: 18 (raises risk) · Who can join
Primary purpose: basic science (raises risk) · Design
Maximum age: 55 (lowers risk) · Who can join
Disease area, neurology: No (lowers risk) · Disease area
Disease area, psychiatry: No (lowers risk) · Disease area

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: 1 (typical: 2)
Number of arms: 2
Allocation: randomized
Design: crossover (typical: parallel)
Primary purpose: basic science (typical: treatment)
Blinding: none
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 2 (typical: 1)

Who can join

Minimum age: 18
Maximum age: 55 (typical: 71)
Sex: all
Accepts healthy volunteers: Yes (typical: 9% yes)

Sponsor's track record

Sponsor type: industry (typical: academic or other)
Sponsor's past trials: 1710 (typical: 32)
Sponsor's past termination rate: 16.1% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 145 (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: 21000 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 2033 (typical: 412.5)
Drug's FAERS reports marked serious: 74.3% (typical: 85.6%)
Drug's FAERS reports with a death: 23.6% (typical: 15.9%)

Disease area and drugs

Disease areas: none of the 14 tracked areas
Drugs matched to FDA substances: epoetin

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

Pharmacokinetic/Pharmacodynamic Study of 3 Subcutaneous Single Dose Epoetin Alfa Formulations in Healthy Volunteers NCT03822884 · started 2016 · scored riskier than 0% of active trials completed
A Phase 3, Long-Term Safety Study of Subcutaneous Epoetin Hospira in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment. AiME -Anemia Management With Epoetin NCT01628120 · started 2012 · scored riskier than 90% of active trials completed
A Phase 3, Long-Term Safety Study of Intravenous Epoetin Hospira in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment. AiME - Anemia Management With Epoetin NCT01628107 · started 2012 · scored riskier than 87% of active trials completed
A Study of Epetraborole Tablets in Subjects With Degrees of Renal Function NCT05283746 · started 2022 · scored riskier than 2% of active trials completed
A Study Comparing the Effects of Epoetin Hospira and Epogen/Epoetin Alfa (Amgen) When Administered IV in Patients With Chronic Renal Failure Requiring Hemodialysis and Receiving Epoetin Maintenance Treatment NCT01170078 · started 2010 · scored riskier than 6% 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.