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NCT00211848 · ClinicalTrials.gov registry record · Phase 2
Antiviral & Antifibrotic Liver Therapy in HCV + Drinkers and Non-Drinkers
A Phase 2 study of Hepatitis C, sponsored by Icahn School of Medicine at Mount Sinai.
- Completed
- Registry status
- Phase 2
- Development phase
- 207
- Enrollment target
- 1
- Study location
NCT00211848 is a Phase 2 study of Hepatitis C that has completed, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 207 participants, below the 1,888-participant average among 106 other Hepatitis C trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00211848, a Phase 2 study of Hepatitis C, has completed, sponsored by Icahn School of Medicine at Mount Sinai.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 207 participants
- Enrollment target
- 1
- Study location
Study Summary
The primary aim of this investigation is to evaluate the effect of a combined antiviral, antifibrotic and antioxidant treatment on the progression of liver disease in patients with hepatitis C who either abstain from alcohol or continue to drink. All subjects are given state-of-the-art antiviral treatment (pegylated interferon + ribavirin), supplemented with either placebo or polyenylphosphatidylcholine (PPC), a purified soybean extract consisting of 95-96% polyunsaturated phosphatidylcholines (PC) and which has both antifibrotic and antioxidant properties. Secondary aims are to verify whether moderate alcohol consumption interferes with the antiviral effect of pegylated interferon + ribavirin on HCV and to validate the reliability of various circulating markers as substitute for liver biopsies to indicate the stage of liver pathology and its propensity for progression.
Conditions Studied
Interventions
- DRUG Ribavirin
- DRUG Polyenylphosphatidylcholine (PPC)
- DRUG Pegylated Interferon
Study Locations (1)
New York
- Bronx VA - The Bronx
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 207 participants |
| Start Date | 2000-06 |
| Est. Completion | 2005-12 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00211848
The ClinicalTrials.gov registry entry for NCT00211848 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 207 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,888-participant average among 106 other Hepatitis C trials with a reported enrollment target (89% lower). The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Hepatitis C appearing as the primary indexed condition, and to 3 interventions - of which Ribavirin is the first listed.
NCT00211848 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT00211848 about?
NCT00211848 is a clinical study titled "Antiviral & Antifibrotic Liver Therapy in HCV + Drinkers and Non-Drinkers". The primary aim of this investigation is to evaluate the effect of a combined antiviral, antifibrotic and antioxidant treatment on the progression of liver disease in patients with hepatitis C who either abstain from alcohol or continue to drink. All subjects are given state-of-the-art antiviral tre...
What is the current status of trial NCT00211848?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 207 participants. The study started on 2000-06. Estimated completion is 2005-12.
What conditions does trial NCT00211848 study?
This clinical trial studies the following conditions: Hepatitis C.
What interventions are being tested in trial NCT00211848?
The interventions under investigation include: Ribavirin (DRUG), Polyenylphosphatidylcholine (PPC) (DRUG), Pegylated Interferon (DRUG).
Who is sponsoring clinical trial NCT00211848?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00211848 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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