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NCT01182298 · ClinicalTrials.gov registry record
Open Label Study to Evaluate Chronic Hepatitis C Treatment in Latino Subjects With and Without HIV Co-infection
A clinical trial, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Terminated
- Registry status
- 10
- Enrollment target
NCT01182298: Clinical Trial study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT01182298 is a clinical trial that was terminated before completion, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 10 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01182298 was terminated before completion, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- TERMINATED
- Registry status
- 10 participants
- Enrollment target
Study Summary
* Peginterferon alfa-2a has been approved by the U.S. Food and Drug Administration (FDA) to treat adults with chronic hepatitis C virus (HCV) infection with liver disease who have not been previously treated with interferon-alpha drugs (which improve immune system response to infection). Ribavirin has been approved by the FDA and is usually given in combination with interferon drugs such as peginterferon alfa-2a for treatment of chronic HCV. * Recent research shows that Latino whites do not respond as well to treatment with peginterferon alfa-2a and ribavirin as non-Latino whites. Various factors such as excessive weight, gender, and insulin resistance were evaluated to explain this difference, but research suggests that underlying factors related to Latino or non-Latino background, possibly genetic and immune differences, may be affecting the response to HCV infection and treatment. However, more research is needed on the effectiveness of peginterferon and ribavirin in Latino subjects with HCV, and with combined and human immunodeficiency virus (HIV) co-infection. Objectives: \- To evaluate the safety, effectiveness, and viral response of peginterferon alfa-2a and ribavirin therapy for chronic hepatitis C in Latino participants with and without HIV co-infection. This is an observational study. The observed treatment is received and managed through their primary care.
Primary Outcome
The primary end point of this study is the the log change in HCV RNA levels on Day 7
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2010-07 |
| Est. Completion | 2013-03 |
Why NCT01182298 stopped before completion
NCT01182298 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 10 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT01182298 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01182298 about?
NCT01182298 is a clinical study titled "Open Label Study to Evaluate Chronic Hepatitis C Treatment in Latino Subjects With and Without HIV Co-infection". * Peginterferon alfa-2a has been approved by the U.S. Food and Drug Administration (FDA) to treat adults with chronic hepatitis C virus (HCV) infection with liver disease who have not been previously treated with interferon-alpha drugs (which improve immune system response to infection). Ribavirin h...
What is the current status of trial NCT01182298?
This trial is currently terminated. The enrollment target is 10 participants. The study started on 2010-07. Estimated completion is 2013-03.
Who is sponsoring clinical trial NCT01182298?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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