Pharmacokinetic/Pharmacodynamic Study of 3 Subcutaneous Single Dose Epoetin Alfa Formulations in Healthy Volunteers

NCT03822884 on ClinicalTrials.gov Phase 1 Bio Sidus SA (industry) Started 2016-09-30 Completed

Among the lowest-risk 1% of active trials

Model scores of the 29,894 trials active now.

Model score 2% 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 14% of the time (117 trials).

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

How it ended

Completed on 2016-12-31, after 2016-09-30 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 2016-12-31. 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

Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: alfaevidence ofhearteffectivewomen
Phrases that lowered it: volunteershealthydepressiveblood pressureformulations
Accepts healthy volunteers: Yes (lowers risk) · Who can join
Design: crossover (lowers risk) · Design
Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
Primary purpose: other (lowers risk) · Design
Phase: 1 (lowers risk) · Design
Minimum age: 21 (lowers risk) · Who can join
Has a data monitoring committee: No (lowers risk) · Design
Drug's FAERS reports with a death: 23.8% (raises risk) · Drug's FDA history
Disease area, cancer: No (lowers risk) · Disease area
Sponsor type: industry (lowers risk) · Sponsor's track record
Drug's FAERS reports before start: 18477 (raises risk) · Drug's FDA history
Maximum age: 55 (lowers risk) · Who can join
Number of arms: 3 (lowers risk) · Design
Disease area, neurology: No (lowers risk) · Disease area
Disease area, psychiatry: No (lowers risk) · Disease area
Drug's FAERS reports marked serious: 75.5% (lowers 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: 1 (typical: 2)
Number of arms: 3 (typical: 2)
Allocation: randomized
Design: crossover (typical: parallel)
Primary purpose: other (typical: treatment)
Blinding: single (typical: 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: 21 (typical: 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: 1 (typical: 32)
Sponsor's past termination rate: 0% (typical: 9.9%)
Trials the sponsor started in the prior 2 years: 0 (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: 18477 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 2070 (typical: 412.5)
Drug's FAERS reports marked serious: 75.5% (typical: 85.6%)
Drug's FAERS reports with a death: 23.8% (typical: 15.9%)

Disease area and drugs

Disease areas: hematology
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

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 · started 2018 · scored riskier than 3% of active trials completed
Generation of Positive Biological Samples to Epoetin for Doping Control. NCT02920372 · started 2016 · scored riskier than 2% of active trials completed
PK and PD Parallel Study After Multiple Dose, Intravenous Administration of Two Epoetin Alfa, Human Recombinant NCT01685359 · started 2013 · scored riskier than 1% of active trials completed
Pharmacokinetics and Pharmacodynamics Assessment of Drug Eritromax Compared to Eprex in Healthy Subjects. NCT03572647 · started 2012 · scored riskier than 1% 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.