ThrombocytopeniaNCT03059030

Yttrium-90 Radioembolization for Cirrhosis-Associated Thrombocytopenia

A study testing TheraSphere® Yttrium-90 Glass Microspheres, BTG International Inc. in people with Thrombocytopenia and Cirrhosis, run by Northwestern University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Evaluate the safety and efficacy of Yttrium-90 (90Y) radioembolization for the management of thrombocytopenia. Read more about this study

Who is it for?: Ages 18 to 99 years
Conditions the study is for: Thrombocytopenia, Cirrhosis
What is being tested?: TheraSphere® Yttrium-90 Glass Microspheres, BTG International Inc.
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 7 participants
Where: 1 siteUnited States
Study dates: 16 Mar 2017to 4 Apr 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female, 18 years of age or older, of any ethnic or racial group.
Diagnosis of cirrhosis or portal hypertension with a serum platelet count less than or equal to 80 × 109/L. [Rationale: platelet count <100 × 109/L triples the rate of liver-related adverse events (3) and worsens postoperative survival in the setting of hepatocellular carcinoma (HCC) (4). Initial platelet count of 80 × 109/L can allow the majority of patients who successfully respond to 90Y-RE (clinical endpoint of 50% platelet count increase) to exceed the 100 × 109/L threshold.]
Cirrhosis is defined by one of three criteria:
Liver Biopsy/histology consistent with cirrhotic architectural liver changes
Portal hypertension (Hepatic venous pressure gradient ≥10 mm Hg)
Evidence of esophageal and/or gastric varices

Show all 13Show fewer

Patients must have evidence of splenomegaly as determined by screening cross-sectional imaging.
No evidence of myelosuppression (e.g. lymphopenia) as evidenced by normal hematology values at Screening
Adequate baseline organ function(with the exception of cirrhosis) as evidenced by normal BUN/Cr and electrolytes on screening chemistry.
Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0-2
Patient has a life expectancy of greater than 6 months without intervention.
Patient is willing to participate in the study and has signed the study informed consent.
Women of childbearing potential must have a negative serum pregnancy test within 28 days prior to screening and must not be breastfeeding.

Who cannot join

Patients with serum platelet count less than 10 × 109/L.
History of bleeding disorder attributed to another cause other than cirrhosis (e.g. Von Willebrand disease)
Declines or unable to provide informed consent
History of prior partial splenic embolization (PSE) or splenectomy
Use of any medication known to increase platelet count 1 month prior to Baseline.
History of allergy or sensitivity to TheraSphere® or its components.

Show all 12Show fewer

History of severe peripheral allergy or intolerance to contrast agents, narcotics, sedatives or atropine that cannot be managed medically
Contraindications to angiography and selective visceral catheterization such as bleeding, diathesis or coagulopathy that is not correctable by usual therapy or hemostatic agents (e.g. closure device)
Previous randomization in a trial using 90Y RE
Patient must not have participated or enrolled in a clinical trial with an investigational device / therapy within 30 days prior to randomization
Any serious medical condition likely to impede successful completion of the study, such as certain mental disorders, cardiac arrhythmias, and uncontrolled congestive heart failure or respiratory disease.
Patients actively on chemotherapy.

Trial locations and contacts

1 site in 1 country.

United States1 site

Northwestern University/Northwestern Memorial Hospital
Chicago, Illinois, 60611

Other trials in United States

About this study

Evaluate the safety and efficacy of Yttrium-90 (90Y) radioembolization for the management of thrombocytopenia.

Read the detailed description

This protocol will provide access to TheraSphere® treatment for patients who have refractory thrombocytopenia secondary to cirrhosis. This protocol will utilize splenic artery-directed TheraSphere® treatment.

Conditions: Thrombocytopenia, Cirrhosis
Being tested: TheraSphere® Yttrium-90 Glass Microspheres, BTG International Inc.
Keywords: Thrombocytopenia, cirrhosis, Therasphere®, Y90, Radioembolization
Medical subject headings: Thrombocytopenia, Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TheraSphere® Yttrium-90 Glass Microspheres, BTG International Inc.Device
The Interventional Radiologists will inject a dose of Yttrium 90 into your spleen through a small catheter placed in your femoral artery.The entire treatment visit is an outpatient procedure. You will only be admitted to the hospital if the physician deems it necessary due to any symptoms you may experience after the treatment is given. This visit may take 6 to 8 hours.

Study groups in NCT03059030
Study group	Role	What they receive
Subjects with thrombocytopenia secondary to cirrhosis	Experimental	Evaluate the safety and efficacy of 90Y radioembolization for the management of thrombocytopenia. Receives: Device: TheraSphere® Yttrium-90 Glass Microspheres, BTG International Inc.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
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
Measured: 6 months
Safety of 90Y RE for the Treatment of Thrombocytopenia in the Setting of Cirrhosis. Reporting of Splenic Abscess.
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, requiring hospitalization and aggressive management.
Grade 4 (Life-threatening):Abscess with immediate life-threatening complications, requiring urgent intervention.
Grade 5 Death
Measured: 6 months
Safety of 90Y RE for the Treatment of Thrombocytopenia in the Setting of Cirrhosis. AE's Related to Infection.
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 4 (Life-threatening): Urgent intervention needed due to life-threatening complications.
Grade 5 (Death): Death directly related to the infection.
Measured: 6 months
Asses the Need for Technetium Albumin Aggregated (TC-MAA 99m) Injection to Determine Shunting Prior to Y90 Administration
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.
Measured: 6 months

Secondary outcomes (3)

Achieve a 50% Increase in Platelet Count Six Months After Therapy.
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.
Measured: 6 months
Achieve 20% Decrease in Functional Splenic Volume Six Months After Treatment
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.
Measured: 6 months
Evaluate Length of Hospital Stay After Procedure
Determine the average length of stay in the hospital in days after treatment.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Mar 20174 Apr 2024

First posted23 Feb 2017
Study start16 Mar 2017
Primary completion4 Apr 2024
Study completion4 Apr 2024

Why it stopped: Low enrollment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for ThrombocytopeniaStudies of the same condition, open and under way.
More trials run by Northwestern UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 7 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03059030
Sponsor's protocol ID: STU 00203772
Status last verified: Jan 2025
First submitted: 8 Feb 2017
Last updated: 3 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
A Study in Children and, Adults With Congenital Thrombotic Thrombocytopenic Purpura (cTTP) Treated With Adzynma
Thrombotic Thrombocytopenic Purpura (TTP)
RecruitingPhase 3
rhTPO for Thrombocytopenia in Chronic Liver Disease Patients Undergoing Elective Invasive Procedures.
Thrombocytopenia Associated With Chronic Liver Disease
RecruitingPhase 2
A Study to Assess the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients With Primary Immune Thrombocytopenia (ITP)
Primary Immune Thrombocytopenia (ITP), Primary Evans Syndrome (ES)
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
RecruitingPhase 1/2
A Study of Pirtobrutinib in Participants With Immune Thrombocytopenia
Immune Thrombocytopenia (ITP)

All Thrombocytopenia trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Yttrium-90 Radioembolization for Cirrhosis-Associated Thrombocytopenia
ClinicalTrials.gov ID: NCT03059030
Acronym / sponsor ID: STU 00203772
Conditions: Thrombocytopenia, Cirrhosis
Keywords: Thrombocytopenia, cirrhosis, Therasphere®, Y90, Radioembolization
Study type: Interventional
Recruitment status: TerminatedReason stopped: Low enrollment
Enrolment: 7 participants (actual)
Lead sponsor: Northwestern UniversityUniversity, hospital or other
Collaborators: BTG International Inc.
Study start: 16 Mar 2017 (actual)
Primary completion: 4 Apr 2024 (actual)
Study completion: 4 Apr 2024 (actual)
First posted: 23 Feb 2017 (actual)
Results: Posted 3 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Evaluate the safety and efficacy of Yttrium-90 (90Y) radioembolization for the management of thrombocytopenia.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Subjects with thrombocytopenia secondary to cirrhosis	Experimental	Device: TheraSphere® Yttrium-90 Glass Microspheres, BTG International Inc.Evaluate the safety and efficacy of 90Y radioembolization for the management of thrombocytopenia.

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (13 listed)

Male or female, 18 years of age or older, of any ethnic or racial group.
Diagnosis of cirrhosis or portal hypertension with a serum platelet count less than or equal to 80 × 109/L. [Rationale: platelet count <100 × 109/L triples the rate of liver-related adverse events (3) and worsens postoperative survival in the setting of hepatocellular carcinoma (HCC) (4). Initial platelet count of 80 × 109/L can allow the majority of patients who successfully respond to 90Y-RE (clinical endpoint of 50% platelet count increase) to exceed the 100 × 109/L threshold.]
Liver Biopsy/histology consistent with cirrhotic architectural liver changes
Portal hypertension (Hepatic venous pressure gradient ≥10 mm Hg)
Evidence of esophageal and/or gastric varices

Key exclusion criteria (12 listed)

Patients with serum platelet count less than 10 × 109/L.
History of bleeding disorder attributed to another cause other than cirrhosis (e.g. Von Willebrand disease)
Declines or unable to provide informed consent
History of prior partial splenic embolization (PSE) or splenectomy
Use of any medication known to increase platelet count 1 month prior to Baseline.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TheraSphere® Yttrium-90 Glass Microspheres, BTG International Inc.The Interventional Radiologists will inject a dose of Yttrium 90 into your spleen through a small catheter placed in your femoral artery.The entire treatment visit is an outpatient procedure. You will only be admitted to the hospital if the physician deems it necessary due to any symptoms you may experience after the treatment is given. This visit may take 6 to 8 hours.	Device	Subjects with thrombocytopenia secondary to cirrhosis

Primary outcome

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.
Time frame: 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
Safety of 90Y RE for the Treatment of Thrombocytopenia in the Setting of Cirrhosis. Reporting of Splenic Abscess.
Time frame: 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, requiring hospitalization and aggressive management. Grade 4 (Life-threatening):Abscess with immediate life-threatening complications, requiring urgent intervention. Grade 5 Death
Safety of 90Y RE for the Treatment of Thrombocytopenia in the Setting of Cirrhosis. AE's Related to Infection.
Time frame: 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 4 (Life-threatening): Urgent intervention needed due to life-threatening complications. Grade 5 (Death): Death directly related to the infection.
Asses the Need for Technetium Albumin Aggregated (TC-MAA 99m) Injection to Determine Shunting Prior to Y90 Administration
Time frame: 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.

3 secondary outcomes

Achieve a 50% Increase in Platelet Count Six Months After Therapy.
Time frame: 6 months
Achieve 20% Decrease in Functional Splenic Volume Six Months After Treatment
Time frame: 6 months
Evaluate Length of Hospital Stay After Procedure
Time frame: 6 months

Results and safety

Results posted to the registry on 3 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Subjects With Thrombocytopenia Secondary to Cirrhosis	7	7

Primary outcome: 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.

Time frame: 6 months. Number. Unit: events

Measure	Subjects With Thrombocytopenia Secondary to Cirrhosis n = 7
Grade 1 AE	49
Grade 2 AE	34
Grade 3 AE	28
Grade 4 AE	15
Grade 5 AE	0

Population analysed: All subjects enrolled received treatment per protocol.

Primary outcome: Safety of 90Y RE for the Treatment of Thrombocytopenia in the Setting of Cirrhosis. Reporting of Splenic Abscess.

Time frame: 6 months. Number. Unit: events

Measure	Subjects With Thrombocytopenia Secondary to Cirrhosis n = 7
Grade 1	0
Grade 2	0
Grade 3	0
Grade 4	0
Grade 5	0

Population analysed: All subjects treated on study.

Primary outcome: Safety of 90Y RE for the Treatment of Thrombocytopenia in the Setting of Cirrhosis. AE's Related to Infection.

Time frame: 6 months. Number. Unit: events

Measure	Subjects With Thrombocytopenia Secondary to Cirrhosis n = 7
Grade 1	0
Grade 2	1
Grade 3	2
Grade 4	0
Grade 5	0

Population analysed: 3 subjects reported infections these were unrelated to treatment on study. Pneumonia grade 3, lung infection grade 3, vaginal infection grade 2. All resolved before the study was completed.

Primary outcome: Asses the Need for Technetium Albumin Aggregated (TC-MAA 99m) Injection to Determine Shunting Prior to Y90 Administration

Time frame: 6 months. Number. Unit: participants

Measure	Subjects With Thrombocytopenia Secondary to Cirrhosis n = 4
Value	0

Population analysed: All four patients that received Tc-MAA to determine shunting prior to Y90 RE had a lung shunt fraction \<5%. Given this finding no subsequent patients needed MAA or lung shunt study performed.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Subjects With Thrombocytopenia Secondary to Cirrhosis	0 of 7 (0%)	7 of 7 (100%)	0 of 7

Limitations and caveats (from the sponsor): Enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results. There were too few eligible candidates or willing participants over several years even with several clinics and a multidisciplinary team reviewing potential candidates. The trial was terminated for low enrollment.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Thrombocytopenia

RecruitingObservational study
A Study in Children and, Adults With Congenital Thrombotic Thrombocytopenic Purpura (cTTP) Treated With Adzynma
Thrombotic Thrombocytopenic Purpura (TTP)
RecruitingPhase 3
rhTPO for Thrombocytopenia in Chronic Liver Disease Patients Undergoing Elective Invasive Procedures.
Thrombocytopenia Associated With Chronic Liver Disease
RecruitingPhase 2
A Study to Assess the Tolerability of Ianalumab (VAY736) With Investigator's Choice Thrombopoietin Receptor Agonist (IC TPO-RA) in Patients With Primary Immune Thrombocytopenia (ITP)
Primary Immune Thrombocytopenia (ITP), Primary Evans Syndrome (ES)
Enrolling by invitationObservational study
Screening for Hematology Branch Protocols
Hematologic Disease and Disorders, Donors
RecruitingPhase 1/2
A Study of Pirtobrutinib in Participants With Immune Thrombocytopenia
Immune Thrombocytopenia (ITP)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Riad Salem, MD principal investigator

Northwestern University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing TheraSphere® Yttrium-90 Glass Microspheres, BTG International Inc. in people with Thrombocytopenia and Cirrhosis, run by Northwestern University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03059030.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2025.