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NCT00846131 · ClinicalTrials.gov registry record · Phase 1
Y-90 Alone or With Sorafenib for Pre-Transplant Hepatocellular Carcinoma
A Phase 1 study of Hepatocellular Carcinoma, sponsored by Northwestern University.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT00846131: Completed Phase 1 study of Hepatocellular Carcinoma, sponsored by Northwestern University.
NCT00846131 is a Phase 1 study of Hepatocellular Carcinoma that has completed, run by Northwestern University. The registered enrollment target is 24 participants, below the 257-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00846131, a Phase 1 study of Hepatocellular Carcinoma, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
A research study to determine the safety, efficacy, and tolerability of Therasphere® (also known as Y-90, or Y-90 Therasphere) combined with or without sorafenib (Nexavar®), in patients with hepatocellular carcinoma (HCC, or liver cancer), awaiting liver transplantation.
Primary Outcome
Subjects randomized to receive Sorafenib take the drug for 2 weeks before treatment with Y90. They have imaging (CT/MRI) 2 weeks after starting Sorafenib then are treated. Post-treatment patients have blood drawn and adverse event evaluation at 2 weeks, 4 weeks, 6 weeks, and then every 6 weeks up to 1 year or time of transplant. Repeat imaging is done at 4 weeks, and then every 3 months post-treatment. Subjects not receiving Sorafenib are treated with Y90 and then are evaluated post-treatment th
Conditions Studied
Interventions
- DRUG Sorafenib
- DRUG Yttrium-90 (Y-90)
Study Locations (1)
Illinois
- Northwestern Memorial Hospital - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2009-02 |
| Est. Completion | 2016-09 |
| Phase | Phase 1 |
What the finished NCT00846131 record still lists
NCT00846131 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 257-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Hepatocellular Carcinoma appearing as the primary indexed condition, and to 2 interventions - of which Sorafenib is the first listed.
NCT00846131 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT00846131 about?
NCT00846131 is a clinical study titled "Y-90 Alone or With Sorafenib for Pre-Transplant Hepatocellular Carcinoma". A research study to determine the safety, efficacy, and tolerability of Therasphere® (also known as Y-90, or Y-90 Therasphere) combined with or without sorafenib (Nexavar®), in patients with hepatocellular carcinoma (HCC, or liver cancer), awaiting liver transplantation.
What is the current status of trial NCT00846131?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2009-02. Estimated completion is 2016-09.
What conditions does trial NCT00846131 study?
This clinical trial studies the following conditions: Hepatocellular Carcinoma.
What interventions are being tested in trial NCT00846131?
The interventions under investigation include: Sorafenib (DRUG), Yttrium-90 (Y-90) (DRUG).
Who is sponsoring clinical trial NCT00846131?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00846131 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hepatocellular Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00846131's enrollment target sits among peer trials
24 118th of 145 higher than 27 of 145 other Hepatocellular Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatocellular Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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