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NCT01592006 · ClinicalTrials.gov registry record · Phase 4
Pegylated Interferon, Ribavirin, Telaprevir in Hepatitis C Virus Infection in Orthotopic Liver Transplant Recipients
A Phase 4 study, sponsored by University of Chicago.
- Terminated
- Registry status
- Phase 4
- Development phase
- 3
- Enrollment target
NCT01592006 is a Phase 4 study that was terminated before completion, run by University of Chicago. The registered enrollment target is 3 participants.
The verdict
NCT01592006, a Phase 4 study, was terminated before completion, sponsored by University of Chicago.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 3 participants
- Enrollment target
Study Summary
Patients are being asked to be part of this study because they are a liver transplant recipient and have the Hepatitis C Virus (HCV). Current routine treatment for HCV for liver transplant patients includes taking two medications called pegylated interferon alfa-2a (Pegasys®) and ribavirin. Patients Pegasys and ribavirin are FDA approved for the treatment of HCV. This study will evaluate the safety and efficacy of adding a third drug called telaprevir for the experimental treatment of HCV in liver transplant patients. The combination of Pegasys, ribavirin and telaprevir is currently FDA approved for the treatment of HCV, but is specifically not FDA approved for HCV patients who have had a liver transplant. This is because more information is needed about possible drug interactions between telaprevir and cyclosporine, or telaprevir and tacrolimus-based immunosuppressive drugs, which are typically part of routine care for transplant patients. Studies have shown that the addition of telaprevir greatly increases the efficacy of Pegasys and ribavirin for the treatment of HCV. However, these studies did not include adequate information on transplant patients due to the potential drug interactions. The investigators hope to gather more information about the safety and efficacy of telaprevir given in combination with Pegasys and ribavirin in the liver transplant patients who have HCV that is not well controlled with Pegasys and ribavirin alone.
Interventions
- DRUG Ribavirin
- DRUG Peginterferon alfa-2a
- DRUG telaprevir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2012-04 |
| Est. Completion | 2014-09 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01592006
The ClinicalTrials.gov registry entry for NCT01592006 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Chicago, which has 796 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Ribavirin is the first listed.
NCT01592006 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01592006 about?
NCT01592006 is a clinical study titled "Pegylated Interferon, Ribavirin, Telaprevir in Hepatitis C Virus Infection in Orthotopic Liver Transplant Recipients". Patients are being asked to be part of this study because they are a liver transplant recipient and have the Hepatitis C Virus (HCV). Current routine treatment for HCV for liver transplant patients includes taking two medications called pegylated interferon alfa-2a (Pegasys®) and ribavirin. Patients...
What is the current status of trial NCT01592006?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 3 participants. The study started on 2012-04. Estimated completion is 2014-09.
What interventions are being tested in trial NCT01592006?
The interventions under investigation include: Ribavirin (DRUG), Peginterferon alfa-2a (DRUG), telaprevir (DRUG).
Who is sponsoring clinical trial NCT01592006?
This trial is sponsored by University of Chicago, which has 796 total clinical trials registered on ClinicalTrials.gov.
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