An Extension Study of HGT-HIT-045 Evaluating Long-Term Safety and Clinical Outcomes of Idursulfase-IT in Conjunction With Elaprase in Pediatric Participants With Hunter Syndrome and Cognitive Impairment

Model scores of the 29,894 trials active now.

Model score 18% 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 15% of the time (95 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.

Cumulative chance of ending terminated (red) or completed (green) by each year from its start; it actually ended on 2024-04-30. 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.

• Accepts healthy volunteers: No (raises risk) · Who can join
• Phase: 1/2 (raises risk) · Design
• Sponsor's past termination rate: 13.4% (raises risk) · Sponsor's track record
• Wording of the registration (title, summary, criteria) (raises risk) · Wording Phrases that raised it: syndromeextensionlongterm safetypediatric
  Phrases that lowered it: participantparticipantsclinicaldisorderbody
• Disease area, neurology: Yes (raises risk) · Disease area
• Design: parallel (raises risk) · Design
• Keywords listed: 27 (raises risk) · Design
• Trials the sponsor started in the prior 2 years: 42 (lowers risk) · Sponsor's track record
• Drug's FAERS reports with a death: 18.9% (lowers risk) · Drug's FDA history
• Has a data monitoring committee: No (lowers risk) · Design
• Sponsor's past trials: 179 (lowers risk) · Sponsor's track record
• Sponsor type: industry (lowers risk) · Sponsor's track record
• Disease area, dermatology: Yes (raises risk) · Disease area
• Disease area, cancer: No (lowers risk) · Disease area
• Maximum age: 18 (raises risk) · Who can join
• Primary purpose: treatment (raises risk) · Design
• Blinding: none (raises risk) · Design
• Drug's FAERS reports marked serious: 99.0% (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.

• Study of Long Term Safety and Clinical Outcomes of Idursulfase IT and Elaprase Treatment in Pediatric Participants Who Have Completed Study HGT-HIT-094 NCT02412787 · started 2015 · scored riskier than 39% of active trials completed
• An Extension Study to Determine Safety and Efficacy for Pediatric Patients With MPS Type IIIA Disease Who Participated in Study HGT-SAN-093. NCT02350816 · started 2015 · scored riskier than 93% of active trials terminated
• Study of Intrathecal Idursulfase-IT Administered in Conjunction With Elaprase® in Pediatric Patients With Hunter Syndrome and Early Cognitive Impairment NCT02055118 · started 2014 · scored riskier than 84% of active trials completed
• A Safety and Dose Ranging Study of Idursulfase (Intrathecal) Administration Via an Intrathecal Drug Delivery Device in Pediatric Patients With Hunter Syndrome Who Have Central Nervous System Involvement and Are Receiving Treatment With Elaprase® NCT00920647 · started 2009 · scored riskier than 74% of active trials completed
• Extension of Study HGT-SAN-055 Evaluating Administration of rhHNS in Patients With Sanfilippo Syndrome Type A (MPS IIIA) NCT01299727 · started 2011 · scored riskier than 76% 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.