Recombinant Human Growth Hormone (RH-GH) For Accelerating Immune Reconstitution Post Unrelated Cord Blood Transplant

NCT00737113 on ClinicalTrials.gov Phase 1 Mitchell Horwitz, MD (academic or other) Started 2008-09-30 Terminated

Riskier than 65% of active trials

Model scores of the 29,894 trials active now.

Model score 19% for any early termination, 8% for termination due to slow enrollment. Past trials like this one (phase, sponsor type and disease area, started 2008–2016) ended terminated 11% of the time (918 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

Terminated on 2013-12-31, after 2008-09-30 start.

Reason given by the sponsor: “enrollment”

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 2013-12-31. 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: celltransplantationallogeneicstempatients must
Phrases that lowered it: kgcriteria patientsefficacymgday
Primary purpose: not given (lowers risk) · Design
Accepts healthy volunteers: No (raises risk) · Who can join
Phase: 1 (lowers risk) · Design
Responsible party: sponsor investigator (raises risk) · Design
Minimum age: 12 (lowers risk) · Who can join
Trials the sponsor started in the prior 2 years: 0 (raises risk) · Sponsor's track record
Sponsor's past termination rate: no earlier finished trials (lowers risk) · Sponsor's track record
Design: single group (raises risk) · Design
Sponsor type: academic or other (raises risk) · Sponsor's track record
Disease area, cancer: No (lowers risk) · Disease area
Maximum age: not given (raises risk) · Who can join
Has a data monitoring committee: No (lowers risk) · Design
Drug's FAERS reports before start: 0 (lowers risk) · Drug's FDA history
Drug's FAERS reports in the prior 12 months: 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.

The trial

Design

Phase: 1 (typical: 2)
Number of arms: not given (typical: 2)
Allocation: not applicable (typical: randomized)
Design: single group (typical: parallel)
Primary purpose: not given (typical: treatment)
Blinding: none
Has a data monitoring committee: No (typical: 56% yes)
Responsible party: sponsor investigator (typical: sponsor)
Collaborators: 1 (typical: 0)
Keywords listed: 3 (typical: 1)

Who can join

Minimum age: 12 (typical: 18)
Maximum age: not given (typical: 71)
Sex: all
Accepts healthy volunteers: No (typical: 9% yes)

Sponsor's track record

Sponsor type: academic or other
Sponsor's past trials: 0 (typical: 32)
Sponsor's past termination rate: no earlier finished trials (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: 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: none of the 14 tracked areas
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

Study of Pregnyl as Adjunct Therapy for High-Risk or Refractory Acute GVHD NCT02525029 · started 2016 · scored riskier than 97% of active trials completed
Safety and Efficacy Study of Recombinant Human Growth Hormone in Adult Growth Hormone Deficiency Patients NCT01822340 · started 2011 · scored riskier than 18% of active trials completed
RGI-2001 for the Prevention of Acute Graft-vs-Host Disease in Subjects Following Allogeneic Hematopoietic Stem Cell Transplantation NCT04014790 · started 2019 · scored riskier than 90% of active trials completed
2018-0674 - IL-7 for T-Cell Recovery Post Haplo and CB Transplant - Phase I/II NCT03941769 · started 2020 · scored riskier than 90% 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

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.