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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: Completed Phase 2 study of Hepatitis C, sponsored by Icahn School of Medicine at Mount Sinai.

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. According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 207 participants
Start Date 2000-06
Est. Completion 2005-12
Phase Phase 2

What the finished NCT00211848 record still lists

NCT00211848 is an interventional study that assigns participants to a tested intervention. The registered 207 participants enrollment target is mid-sized for trials with a published cap, below the 1,888-participant average among 106 other Hepatitis C trials with a reported enrollment target (89% lower).

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 a single indexed study location in 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.

Similar trials for Hepatitis C

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00211848's enrollment target sits among peer trials

207 41st of 106 higher than 66 of 106 other Hepatitis C trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Hepatitis C 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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Source: ClinicalTrials.gov NCT00211848, the US trial registry maintained by the National Library of Medicine. NCT00211848 (mid enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.