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NCT01165359 · ClinicalTrials.gov registry record · Phase 1

Evaluating the Safety of ITX 5061 in Treatment-Naive Hepatitis C (HCV)-Infected Adults

A Phase 1 study of Hepatitis C, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

Completed
Registry status
Phase 1
Development phase
30
Enrollment target
10
Study locations

NCT01165359 is a Phase 1 study of Hepatitis C that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 30 participants, below the 1,890-participant average among 106 other Hepatitis C trials with a reported enrollment target (98% lower). The trial reports 10 study locations across 8 states.

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The verdict

NCT01165359, a Phase 1 study of Hepatitis C, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).

COMPLETED
Registry status
Phase 1
Development phase
30 participants
Enrollment target
10
Study locations

Study Summary

Hepatitis C (HCV) is a disease that affects the liver. ITX 5061 is a new medication that is being tested to treat HCV. This study will evaluate the safety of ITX 5061 and examine different doses of the medication to evaluate which dose is the most effective at lowering the amount of HCV in the blood.

Conditions Studied

Hepatitis C

Interventions

  • DRUG ITX 5061
  • DRUG Placebo ITX 5061

Study Locations (10)

California

  • UCLA CARE Center CRS - Los Angeles
  • Ucsd, Avrc Crs - San Diego
  • Ucsf Aids Crs - San Francisco

Alabama

  • Alabama Therapeutics CRS - Birmingham

Maryland

  • Johns Hopkins Adult AIDS CRS - Baltimore

New York

  • Univ. of Rochester ACTG CRS - Rochester

North Carolina

  • Duke Univ. Med. Ctr. Adult CRS - Durham

Ohio

  • Univ. of Cincinnati CRS - Cincinnati

Pennsylvania

  • Hosp. of the Univ. of Pennsylvania CRS - Philadelphia

Other

  • Puerto Rico-AIDS CRS - San Juan

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2010-09
Est. Completion 2012-03
Phase Phase 1

Sponsor

National Institute of Allergy and Infectious Diseases (NIAID)

2,006 total trials

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What the Registry Record Tells You About NCT01165359

The ClinicalTrials.gov registry entry for NCT01165359 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,890-participant average among 106 other Hepatitis C trials with a reported enrollment target (98% lower). The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Hepatitis C appearing as the primary indexed condition, and to 2 interventions - of which ITX 5061 is the first listed.

NCT01165359 reports 10 study locations spanning 8 distinct geographic areas - top geographies include California, Alabama, Maryland.

Frequently Asked Questions

What is clinical trial NCT01165359 about?

NCT01165359 is a clinical study titled "Evaluating the Safety of ITX 5061 in Treatment-Naive Hepatitis C (HCV)-Infected Adults". Hepatitis C (HCV) is a disease that affects the liver. ITX 5061 is a new medication that is being tested to treat HCV. This study will evaluate the safety of ITX 5061 and examine different doses of the medication to evaluate which dose is the most effective at lowering the amount of HCV in the blood...

What is the current status of trial NCT01165359?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2010-09. Estimated completion is 2012-03.

What conditions does trial NCT01165359 study?

This clinical trial studies the following conditions: Hepatitis C.

What interventions are being tested in trial NCT01165359?

The interventions under investigation include: ITX 5061 (DRUG), Placebo ITX 5061 (DRUG).

Who is sponsoring clinical trial NCT01165359?

This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01165359 being conducted?

This trial has 10 study locations across Alabama, California, Maryland, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.