Safety, PK/PD (Pharmacokinetics/Pharmacodynamics) and Efficacy of ACP-001 Weekly Versus Daily hGH in Children With Growth Hormone Deficiency (GHD)

NCT01947907 on ClinicalTrials.gov Phase 2 Ascendis Pharma A/S (industry) Started 2013-07-31 Completed

Riskier than 19% of active trials

Model scores of the 29,894 trials active now.

Model score 11% for any early termination, 2% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 19% of the time (731 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 2015-09-30, after 2013-07-31 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 2015-09-30. 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

Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
Accepts healthy volunteers: No (raises risk) · Who can join
Wording of the registration (title, summary, criteria) (lowers risk) · Wording Phrases that raised it: childrengrowthhumantherapystage
Phrases that lowered it: dailypharmacokineticsefficacyparallelhistory or
Phase: 2 (raises risk) · Design
Number of arms: 4 (lowers risk) · Design
Disease area, neurology: Yes (raises risk) · Disease area
Disease area, cancer: No (lowers risk) · Disease area
Minimum age: 3 (lowers risk) · Who can join
Has a data monitoring committee: Yes (raises risk) · Design
Design: parallel (raises risk) · Design
Primary purpose: treatment (raises risk) · Design
Drug's FAERS reports with a death: 13.8% (lowers risk) · Drug's FDA history
Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
Drug's FAERS reports marked serious: 95.3% (raises risk) · Drug's FDA history
Maximum age: 12 (raises risk) · Who can join
Sponsor type: industry (lowers risk) · Sponsor's track record
Sponsor's past trials: 2 (lowers risk) · Sponsor's track record
Collaborators: 0 (raises risk) · Design
Blinding: none (raises 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: randomized
Design: parallel
Primary purpose: treatment
Blinding: none
Has a data monitoring committee: Yes (typical: 56% yes)
Responsible party: sponsor
Collaborators: 0
Keywords listed: 4 (typical: 1)

Who can join

Minimum age: 3 (typical: 18)
Maximum age: 12 (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: 2 (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: 2105 (typical: 2148)
Drug's FAERS reports in the prior 12 months: 670 (typical: 412.5)
Drug's FAERS reports marked serious: 95.3% (typical: 85.6%)
Drug's FAERS reports with a death: 13.8% (typical: 15.9%)

Disease area and drugs

Disease areas: neurology, musculoskeletal, endocrine
Drugs matched to FDA substances: somatropin

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 Safety, Pharmacokinetic and Pharmacodynamic Study of ACP-001 (TransCon hGH) in Adults With Growth Hormone Deficiency NCT01247675 · started 2010 · scored riskier than 10% of active trials completed
A Phase 3 Trial of the Safety, Tolerability and Efficacy of TransCon hGH Weekly Versus Daily hGH in Children With Growth Hormone Deficiency (GHD) NCT02781727 · started 2016 · scored riskier than 43% of active trials completed
Versartis Trial in Children to Assess Long-Acting Growth Hormone NCT01718041 · started 2012 · scored riskier than 44% of active trials completed
Efficacy and Safety of DA-3002 in Children With Idiopathic Short Stature NCT01786902 · started 2012 · scored riskier than 6% of active trials completed
Investigating Efficacy and Safety of Once-weekly NNC0195-0092 Treatment Compared to Daily Growth Hormone Treatment (Norditropin® FlexPro®) in Growth Hormone Treatment naïve Pre-pubertal Children With Growth Hormone Deficiency NCT02616562 · started 2016 · scored riskier than 35% 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.