Comparative Study of Clinical Efficacy and Safety of GNR-069 and Nplate in Patients With ITP
Model scores of the 29,894 trials active now.
Model score 9% 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 9% of the time (336 trials).
Finished trial that started in 2015 or later: the model never saw it during training.
How it ended
Completed on 2023-10-19, after 2021-09-09 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 2023-10-19. 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
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Sponsor's past termination rate: 0% (lowers risk) · Sponsor's track record
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Accepts healthy volunteers: No (raises risk) · Who can join
-
Phase: 3 (lowers risk) · Design
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Wording of the registration (title, summary, criteria) (lowers risk) · Wording
Phrases that raised it: therapypatientrituximabcountplatelet
Phrases that lowered it: and safetyreferenceefficacy andscreeningsafety of -
Design: parallel (raises risk) · Design
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Disease area, cancer: No (lowers risk) · Disease area
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Drug's FAERS reports with a death: 19.1% (lowers risk) · Drug's FDA history
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Trials the sponsor started in the prior 2 years: 6 (raises risk) · Sponsor's track record
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Minimum age: 18 (raises risk) · Who can join
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Sponsor type: industry (lowers risk) · Sponsor's track record
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Has a data monitoring committee: No (lowers risk) · Design
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Primary purpose: treatment (raises risk) · Design
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Blinding: double (raises risk) · Design
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Keywords listed: 28 (raises risk) · Design
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Maximum age: 75 (lowers risk) · Who can join
-
Number of arms: 2 (raises risk) · Design
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Drug's FAERS reports marked serious: 80.4% (lowers risk) · Drug's FDA history
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Responsible party: sponsor (lowers 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
- 3 (typical: 2)
- Number of arms
- 2
- Allocation
- randomized
- Design
- parallel
- Primary purpose
- treatment
- Blinding
- double (typical: none)
- Has a data monitoring committee
- No (typical: 56% yes)
- Responsible party
- sponsor
- Collaborators
- 0
- Keywords listed
- 28 (typical: 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
- 9 (typical: 32)
- Sponsor's past termination rate
- 0% (typical: 9.9%)
- Trials the sponsor started in the prior 2 years
- 6 (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
- 11645 (typical: 2148)
- Drug's FAERS reports in the prior 12 months
- 554 (typical: 412.5)
- Drug's FAERS reports marked serious
- 80.4% (typical: 85.6%)
- Drug's FAERS reports with a death
- 19.1% (typical: 15.9%)
Disease area and drugs
- Disease areas
- immunology, hematology
- Drugs matched to FDA substances
- romiplostim
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
- Safety and Efficacy Study of PG2 to Treat Idiopathic Thrombocytopenic Purpura (ITP) Patients NCT00860600 · started 2008 · scored riskier than 67% of active trials completed
- Study of the Safety and Immunogenicity of Long-term GNR-069 Therapy in ITP Patients NCT05492409 · started 2022 · scored riskier than 13% of active trials completed
- A Study to Evaluate the Efficacy and Safety of Efgartigimod PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia NCT04687072 · started 2020 · scored riskier than 48% of active trials completed
- Study of a New Medication for Childhood Chronic Immune Thrombocytopenia (ITP), a Blood Disorder of Low Platelet Counts That Can Lead to Bruising Easily, Bleeding Gums, and/or Bleeding Inside the Body. NCT01520909 · started 2012 · scored riskier than 88% of active trials completed
- A Clinical Study on the Efficacy and Safety of HBM9161 in Patients With ITP NCT04428255 · started 2020 · scored riskier than 15% 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.