Immune Tolerance Study With Aldurazyme® (Laronidase)
Model scores of the 29,894 trials active now.
Model score 17% for any early termination, 6% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 8% of the time (60 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 2012-09-30, after 2008-09-30 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 2012-09-30. 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
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Wording of the registration (title, summary, criteria) (raises risk) · Wording
Phrases that raised it: purpose ofthe purposecardiovascular hepaticneurologic orgenotype
Phrases that lowered it: participanttrialparticipantsvaccinationpatients -
Sponsor's past termination rate: 14.2% (raises risk) · Sponsor's track record
-
Phase: 1/2 (raises risk) · Design
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Trials the sponsor started in the prior 2 years: 38 (lowers risk) · Sponsor's track record
-
Disease area, cancer: No (lowers risk) · Disease area
-
Primary purpose: treatment (raises risk) · Design
-
Design: single group (raises risk) · Design
-
Minimum age: not given (raises risk) · Who can join
-
Sponsor type: industry (lowers risk) · Sponsor's track record
-
Blinding: none (raises risk) · Design
-
Disease area, dermatology: Yes (raises risk) · Disease area
-
Sponsor's past trials: 120 (lowers risk) · Sponsor's track record
-
Number of arms: 2 (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
- 1/2 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 1 (typical: 0)
- Keywords listed
- 1
Who can join
- Minimum age
- not given (typical: 18)
- Maximum age
- 5 (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
- 120 (typical: 32)
- Sponsor's past termination rate
- 14.2% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 38 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 3 (typical: 1)
- Drug has FAERS history
- Yes (typical: 64% yes)
- Drug's FAERS reports before start
- 12408 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 3281 (typical: 412.5)
- Drug's FAERS reports marked serious
- 92.6% (typical: 85.6%)
- Drug's FAERS reports with a death
- 22.3% (typical: 15.9%)
Disease area and drugs
- Disease areas
- metabolic, dermatology
- Drugs matched to FDA substances
- azathioprine, cyclosporine, laronidase
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
- Efficacy and Safety of YW17 (Laronidase-CinnaGen) Compared to Aldurazyme® in MPS I Patients NCT06406153 · started 2022 · scored riskier than 6% of active trials completed
- Efficacy METAZYM for the Treatment Metachromatic Leukodystrophy Treated With Hematopoietic Stem Cell Transplantation NCT01303146 · started 2008 · scored riskier than 84% of active trials completed
- Gene Therapy in Patients With Mucopolysaccharidosis Disease NCT03173521 · started 2017 · scored riskier than 55% of active trials completed
- Safety and Dose Ranging Study of Insulin Receptor MAb-IDUA Fusion Protein in Patients With MPS I NCT02371226 · started 2015 · scored riskier than 66% of active trials completed
- Safety and Dose Ranging Study of Human Insulin Receptor MAb-IDUA Fusion Protein in Adults and Children With MPS I NCT03053089 · started 2015 · scored riskier than 70% 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.