Extension Study of Efficacy and Safety of LTP001 in Pulmonary Arterial Hypertension Participants
Model scores of the 29,894 trials active now.
Model score 25% for any early termination, 4% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 20% of the time (389 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Terminated on 2024-05-14, after 2023-03-27 start.
Reason given by the sponsor: “business”
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 2024-05-14. 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) (raises risk) · Wording
Phrases that raised it: long termpulmonarypostterm safetythe long
Phrases that lowered it: participantparticipantsand safetyefficacy andweeks before -
Sponsor's past termination rate: 16.5% (raises risk) · Sponsor's track record
-
Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 2 (raises risk) · Design
-
Sponsor's past trials: 1522 (raises risk) · Sponsor's track record
-
Has a data monitoring committee: Yes (raises risk) · Design
-
Design: single group (raises risk) · Design
-
Drug's FAERS reports with a death: no FAERS history (raises risk) · Drug's FDA history
-
Trials the sponsor started in the prior 2 years: 167 (lowers risk) · Sponsor's track record
-
Drug's FAERS reports marked serious: no FAERS history (raises risk) · Drug's FDA history
-
Primary purpose: treatment (raises risk) · Design
-
Minimum age: 18 (raises risk) · Who can join
-
Disease area, cancer: No (lowers risk) · Disease area
-
Disease area, respiratory: Yes (raises risk) · Disease area
-
Drug's FAERS reports before start: 0 (raises risk) · Drug's FDA history
-
Disease area, cardiovascular: Yes (raises risk) · Disease area
-
Collaborators: 0 (raises risk) · Design
-
Maximum age: 75 (raises risk) · Who can join
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
- 1 (typical: 2)
- Allocation
- not applicable (typical: randomized)
- Design
- single group (typical: parallel)
- Primary purpose
- treatment
- Blinding
- none
- Has a data monitoring committee
- Yes (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 1
Who can join
- Minimum age
- 18
- Maximum age
- 75 (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
- 1522 (typical: 32)
- Sponsor's past termination rate
- 16.5% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 167 (typical: 19)
Drug's FDA history
- Drugs with FDA adverse-event history
- 0 (typical: 1)
- Drug has FAERS history
- No (typical: 64% yes)
- Drug's FAERS reports before start
- 0 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 0 (typical: 412.5)
- Drug's FAERS reports marked serious
- no FAERS history (typical: 85.6%)
- Drug's FAERS reports with a death
- no FAERS history (typical: 15.9%)
Disease area and drugs
- Disease areas
- cardiovascular, respiratory
- Drugs matched to FDA substances
- none matched
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
- Long-Term, Open Label Extension Study of Pemziviptadil (PB1046) in PAH Subjects Following Completion of Study PB1046-PT-CL-0004 NCT03795428 · started 2019 · scored riskier than 83% of active trials terminated
- Safety and Efficacy of BIA 5-1058 in PAH NCT06009185 · started 2019 · scored riskier than 33% of active trials completed
- Long-term Safety and Efficacy of Ralinepag in Pulmonary Arterial Hypertension NCT02279745 · started 2015 · scored riskier than 99% of active trials completed
- A Study of Sotatercept for the Treatment of Pulmonary Arterial Hypertension (MK-7962-003/A011-11)(STELLAR) NCT04576988 · started 2021 · scored riskier than 81% of active trials completed
- Tamoxifen Therapy to Treat Pulmonary Arterial Hypertension NCT03528902 · started 2018 · scored riskier than 87% 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.