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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: Completed Phase 2 study of Clinically Significant Portal Hypertension, sponsored by Yale University.
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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower). The trial reports 6 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Number of participants with a decrease in HPVG that was \> 10% of baseline
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 |
What the finished NCT01714609 record still lists
NCT01714609 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (92% lower).
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 lists 6 locations in 5 states (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
How this trial's enrollment target compares
Where NCT01714609's enrollment target sits among peer trials
10 1968th of 2000 higher than 12 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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