Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01714609 · ClinicalTrials.gov registry record · Phase 2
The Effect of Sorafenib on Portal Pressure
A Phase 2 study of Clinically Significant Portal Hypertension, sponsored by Yale University.
- Completed
- Registry status
- Phase 2
- Development phase
- 10
- Enrollment target
- 6
- Study locations
NCT01714609 is a Phase 2 study of Clinically Significant Portal Hypertension that has completed, run by Yale University. The registered enrollment target is 10 participants. The trial reports 6 study locations across 5 states.
The verdict
NCT01714609, a Phase 2 study of Clinically Significant Portal Hypertension, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 10 participants
- Enrollment target
- 6
- Study locations
Study Summary
Sorafenib is approved by the US FDA for the treatment of unresectable (can not operate) liver cancer and for renal cell carcinoma. Sorafenib is a drug that inhibits the growth of cancer cells and prevents the formation of new blood vessels that would otherwise help the cancer spread. Studies in experimental animals have shown that sorafenib may also lower portal vein pressure (the pressure of the blood passing from the intestine through the liver.) This study seeks to determine if sorafenib lowers the blood pressure in liver blood vessels (portal vein pressure) in patients with cirrhosis who have high portal vein pressure. The study will also obtain information whether sorafenib is safe in this patient population. Half of the patients will be given sorafenib and half will be given a placebo (a pill without any medicine in it.) This allows a comparison of the reactions of people who take sorafenib to those who do not.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Sorafenib
Study Locations (6)
Connecticut
- Yale Cancer Center - New Haven
- VA Medical Center West Haven - West Haven
Massachusetts
- Brigham & Womens - Boston
New York
- New York University Langone Medical Center - New York
Pennsylvania
- University of Pennsylvania School of Medicine - Philadelphia
Texas
- The University of Texas Health Science Center at Houston - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2011-08 |
| Est. Completion | 2014-09 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01714609
The ClinicalTrials.gov registry entry for NCT01714609 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 10 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Clinically Significant Portal Hypertension appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01714609 reports 6 study locations spanning 5 distinct geographic areas - top geographies include Connecticut, Massachusetts, New York.
Frequently Asked Questions
What is clinical trial NCT01714609 about?
NCT01714609 is a clinical study titled "The Effect of Sorafenib on Portal Pressure". Sorafenib is approved by the US FDA for the treatment of unresectable (can not operate) liver cancer and for renal cell carcinoma. Sorafenib is a drug that inhibits the growth of cancer cells and prevents the formation of new blood vessels that would otherwise help the cancer spread. Studies in exp...
What is the current status of trial NCT01714609?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 10 participants. The study started on 2011-08. Estimated completion is 2014-09.
What conditions does trial NCT01714609 study?
This clinical trial studies the following conditions: Clinically Significant Portal Hypertension.
What interventions are being tested in trial NCT01714609?
The interventions under investigation include: Placebo (DRUG), Sorafenib (DRUG).
Who is sponsoring clinical trial NCT01714609?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01714609 being conducted?
This trial has 6 study locations across Connecticut, Massachusetts, New York, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.