Yttrium-90 Radioembolization for Cirrhosis-Associated Thrombocytopenia
TerminatedNAResults postedLast updated 3 February 2025
What this trial tests
NA trial testing TheraSphere® Yttrium-90 Glass Microspheres, BTG International Inc. in Thrombocytopenia in 7 participants. Terminated before completion.
Timeline
16 March 2017
Primary endpoint 4 April 2024
4 April 2024
Quick facts
Lead sponsor
Northwestern University
Phase
NA
Status
Terminated
Study type
INTERVENTIONAL
Allocation
na
Design
single group
Masking
none
Primary purpose
treatment
Enrollment
7
Start date
16 March 2017
Primary completion
4 April 2024
Estimated completion
4 April 2024
Sites
1 location across United States
Drugs / interventions tested
TheraSphere® Yttrium-90 Glass Microspheres, BTG International Inc.
Adults 18 to 99, any sex, with Thrombocytopenia or Cirrhosis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The Primary Objective of This Pilot Study is to Evaluate the Safety of 90Y TARE for the Treatment of Thrombocytopenia in the Setting of Cirrhosis. Evaluation of Overall AE Reporting in All Categories.Primary· 6 months
The number and the severity of ALL adverse events will be recorded to evaluate safety. Events will be reported by subjects at follow up visits.
Scale: Common Terminology Criteria for Adverse Events (CTCAE) CT CAE v 4.0.3 Grades range from 1-5 with 5 being the worst (Death), descriptions of each grade for specific AE's are available here: https://evs.nci.nih.gov/ftp1/CTCAE/CTCAE\_4.03/CTCAE\_4.03\_2010-06-14\_QuickReference\_8.5x11.pdf Total AE's of different types are collected and for each grade are reported as a group
Grade 1 AE
Group
Value
95% CI
Subjects With Thrombocytopenia Secondary to Cirrhosis
49
Grade 2 AE
Group
Value
95% CI
Subjects With Thrombocytopenia Secondary to Cirrhosis
34
Grade 3 AE
Group
Value
95% CI
Subjects With Thrombocytopenia Secondary to Cirrhosis
28
Grade 4 AE
Group
Value
95% CI
Subjects With Thrombocytopenia Secondary to Cirrhosis
15
Grade 5 AE
Group
Value
95% CI
Subjects With Thrombocytopenia Secondary to Cirrhosis
0
Safety of 90Y RE for the Treatment of Thrombocytopenia in the Setting of Cirrhosis. Reporting of Splenic Abscess.Primary· 6 months
The number and the severity of adverse events related to splenic abscess will be recorded to evaluate safety. Events will be reported by subjects at follow up visits.
Scale: Common Terminology Criteria for Adverse Events (CTCAE) CT CAE v 4.0.3 Grades range from 1-5 with 5 being the worst (Death), Grade 1 (Mild):Small abscess with minimal symptoms, often not requiring intervention.
Grade 2 (Moderate):Larger abscess causing moderate symptoms, may require antibiotics or drainage procedures.
Grade 3 (Severe):Large abscess with significant symptoms, potentially causing systemic effects, requirin
Grade 1
Group
Value
95% CI
Subjects With Thrombocytopenia Secondary to Cirrhosis
0
Grade 2
Group
Value
95% CI
Subjects With Thrombocytopenia Secondary to Cirrhosis
0
Grade 3
Group
Value
95% CI
Subjects With Thrombocytopenia Secondary to Cirrhosis
0
Grade 4
Group
Value
95% CI
Subjects With Thrombocytopenia Secondary to Cirrhosis
0
Grade 5
Group
Value
95% CI
Subjects With Thrombocytopenia Secondary to Cirrhosis
0
Safety of 90Y RE for the Treatment of Thrombocytopenia in the Setting of Cirrhosis. AE's Related to Infection.Primary· 6 months
The number and the severity of adverse events related to infection will be recorded to evaluate safety. Events will be reported by subjects at follow up visits.
Common Terminology Criteria for Adverse Events (CTCAE) CT CAE v 4.0.3, Grades range from 1-5 with 5 being the worst (Death) Grade 1 (Mild): Asymptomatic or mild symptoms, only requiring clinical observation, no intervention needed.
Grade 2 (Moderate): Symptoms limiting some daily activities, minimal intervention may be required.
Grade 3 (Severe): Symptoms significantly impacting self-care, requiring hospitalization or prolonged stay
Grade 1
Group
Value
95% CI
Subjects With Thrombocytopenia Secondary to Cirrhosis
0
Grade 2
Group
Value
95% CI
Subjects With Thrombocytopenia Secondary to Cirrhosis
1
Grade 3
Group
Value
95% CI
Subjects With Thrombocytopenia Secondary to Cirrhosis
2
Grade 4
Group
Value
95% CI
Subjects With Thrombocytopenia Secondary to Cirrhosis
0
Grade 5
Group
Value
95% CI
Subjects With Thrombocytopenia Secondary to Cirrhosis
0
Asses the Need for Technetium Albumin Aggregated (TC-MAA 99m) Injection to Determine Shunting Prior to Y90 AdministrationPrimary· 6 months
MAA injection will be done and nuclear medicine PET scan to evaluate shunting and evaluated for the first 4 patients. If shunt is \<5% subsequently enrolled patients will not undergo MAA, if shunt is \>5% all subsequent patients will undergo MAA. This will be evaluated post MAA injection before Y90 treatment.
Group
Value
95% CI
Subjects With Thrombocytopenia Secondary to Cirrhosis
0
Achieve a 50% Increase in Platelet Count Six Months After Therapy.Secondary· 6 months
Complete Blood Count with platelets will be drawn at baseline, treatment, 2, 4, 6, 8 weeks and 3, 4, 5, 6 months post treatment. Comparison made with screening platelet count and 6 month follow up visit platelet count.
Achieved 50% increase in 6 months
Group
Value
95% CI
Subjects With Thrombocytopenia Secondary to Cirrhosis
0
Did not achieve 50% increase in 6 months
Group
Value
95% CI
Subjects With Thrombocytopenia Secondary to Cirrhosis
7
Achieve 20% Decrease in Functional Splenic Volume Six Months After TreatmentSecondary· 6 months
Assessed via cross sectional CT or MR of the abdomen at screening and at 4 weeks, 3 months, and 6 months post treatment. Comparison made with screening CT or MR and 6 month follow up imaging.
Achieved 20% decrease in volume
Group
Value
95% CI
Subjects With Thrombocytopenia Secondary to Cirrhosis
1
Did not achieve 20% decrease in volume
Group
Value
95% CI
Subjects With Thrombocytopenia Secondary to Cirrhosis
6
Adverse events — posted to ClinicalTrials.gov
Time frame: 6 months.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Subjects With Thrombocytopenia Secondary to Cirrhosis
NCT06886516 — Apixaban in Thrombocytopenia
· EARLY_PHASE1
· recruiting
Other Northwestern University trials
Trials by the same sponsor.
NCT06545695 — Epidermal Growth Factor Receptor Inhibition for Keratinopathies
· Phase 1, PHASE2
· not yet recruiting
NCT07261657 — N-803 in Patients With Progressive Synovial Sarcoma and Myxoid/Round Cell Liposarcoma Previously Treated With Adoptive C
· EARLY_PHASE1
· not yet recruiting
NCT07392775 — ALDH2 Genetic Testing in East Asian Community
· NA
· not yet recruiting
NCT06886776 — Implementing A Secure Firearm Storage Program in Illinois Health Centers in Partnership With AllianceChicago and the Ill
· NA
· not yet recruiting
NCT07469176 — Co-Designing and Evaluating Additional Mothers and Babies Program Content for Expectant and New Parents of Children With
· NA
· not yet recruiting
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Northwestern University
Last refreshed: 3 February 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03059030.