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NCT01849588 · ClinicalTrials.gov registry record · Phase 4
HCV-RNA Kinetics During Sorafenib for Hepatocellular Carcinoma (HCC)
A Phase 4 study, sponsored by Massachusetts General Hospital.
- Terminated
- Registry status
- Phase 4
- Development phase
- 3
- Enrollment target
NCT01849588: Clinical Trial Phase 4 study, sponsored by Massachusetts General Hospital.
NCT01849588 is a Phase 4 study that was terminated before completion, run by Massachusetts General Hospital. The registered enrollment target is 3 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01849588, a Phase 4 study, was terminated before completion, sponsored by Massachusetts General Hospital.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 3 participants
- Enrollment target
Study Summary
This research study is a Phase IV clinical trial. Phase IV trials are used to further test and monitor the safety of a drug approved by the FDA and to see if the drug has any other indications that can be used to treat different diseases. Sorafenib is a new drug, which is approved under the brand name Nexavar for the treatment of liver cancer. It is also currently being tested in various other cancers. Sorafenib works by slowing down and/or stopping the development of new cancer cells and new blood vessels. By slowing down and/or stopping the growth of new blood vessels around a tumor, it is believed that sorafenib prevents or slows down the growth of tumors. The researchers of this study would like to study the effects of sorafenib on hepatitis C by drawing additional research blood samples from people infected with hepatitis C who are receiving sorafenib treatment for liver cancer. These tests will measure certain proteins in the blood (HCV-RNA) which may indicate if sorafenib has any effect on the hepatitis C virus.
Primary Outcome
Successful decline in HCV (hepatitis C virus)-RNA level, with success defined as a decrease of at least two logs of HCV-RNA between baseline and any subsequent measurement.
Interventions
- DRUG Sorafenib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2013-05 |
| Est. Completion | 2017-01 |
| Phase | Phase 4 |
Why NCT01849588 stopped before completion
NCT01849588 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Sorafenib is the first listed.
NCT01849588 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01849588 about?
NCT01849588 is a clinical study titled "HCV-RNA Kinetics During Sorafenib for Hepatocellular Carcinoma (HCC)". This research study is a Phase IV clinical trial. Phase IV trials are used to further test and monitor the safety of a drug approved by the FDA and to see if the drug has any other indications that can be used to treat different diseases. Sorafenib is a new drug, which is approved under the brand n...
What is the current status of trial NCT01849588?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 3 participants. The study started on 2013-05. Estimated completion is 2017-01.
What interventions are being tested in trial NCT01849588?
The interventions under investigation include: Sorafenib (DRUG).
Who is sponsoring clinical trial NCT01849588?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01849588's enrollment target sits among peer trials
3 1995th of 2000 higher than 3 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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