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NCT02864199 · ClinicalTrials.gov registry record · Phase 4

A Study of Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) Combination Therapy in Participants With Chronic Hepatitis C (CHC) and Various Degrees of Renal Impairment

A Phase 4 study of Hepatitis C, Chronic, sponsored by Hoffmann-La Roche.

Completed
Registry status
Phase 4
Development phase
63
Enrollment target
17
Study locations

NCT02864199 is a Phase 4 study of Hepatitis C, Chronic that has completed, run by Hoffmann-La Roche. The registered enrollment target is 63 participants, below the 374-participant average among 26 other Hepatitis C, Chronic trials with a reported enrollment target (83% lower). The trial reports 17 study locations across 10 states.

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The verdict

NCT02864199, a Phase 4 study of Hepatitis C, Chronic, has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
Phase 4
Development phase
63 participants
Enrollment target
17
Study locations

Study Summary

This study will evaluate the pharmacokinetics (area under the curve \[AUC\], maximum concentration \[Cmax\], and other parameters) and tolerability of peginterferon alfa-2a and ribavirin combination therapy following single and multiple doses in participants with CHC infection and moderate to severe renal impairment or end-stage renal disease (ESRD) receiving hemodialysis. The anticipated time on study treatment is up to 48 weeks, and the target sample size is 48 individuals.

Conditions Studied

Hepatitis C, Chronic

Interventions

  • DRUG Ribavirin
  • DRUG Peginterferon alfa-2a

Study Locations (17)

Other

  • - São Paulo
  • - Marseille
  • - Christchurch
  • - Riccarton, Christchurch
  • - Huddinge

Missouri

  • - Kansas City
  • - St Louis

New York

  • - New York
  • - Syracuse

Texas

  • - Dallas
  • - Galveston

Alabama

  • - Birmingham

Kansas

  • - Kansas City

Louisiana

  • - New Orleans

Ohio

  • - Cleveland

Trial Details

FieldValue
Enrollment Target 63 participants
Start Date 2004-02
Est. Completion 2007-09
Phase Phase 4

Sponsor

Hoffmann-La Roche

909 total trials

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What the Registry Record Tells You About NCT02864199

The ClinicalTrials.gov registry entry for NCT02864199 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 63 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 374-participant average among 26 other Hepatitis C, Chronic trials with a reported enrollment target (83% lower). The listed sponsor is Hoffmann-La Roche, which has 909 total studies on file at ClinicalTrials.gov.

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

NCT02864199 reports 17 study locations spanning 10 distinct geographic areas - top geographies include Other, Missouri, New York.

Frequently Asked Questions

What is clinical trial NCT02864199 about?

NCT02864199 is a clinical study titled "A Study of Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) Combination Therapy in Participants With Chronic Hepatitis C (CHC) and Various Degrees of Renal Impairment". This study will evaluate the pharmacokinetics (area under the curve \[AUC\], maximum concentration \[Cmax\], and other parameters) and tolerability of peginterferon alfa-2a and ribavirin combination therapy following single and multiple doses in participants with CHC infection and moderate to severe...

What is the current status of trial NCT02864199?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 63 participants. The study started on 2004-02. Estimated completion is 2007-09.

What conditions does trial NCT02864199 study?

This clinical trial studies the following conditions: Hepatitis C, Chronic.

What interventions are being tested in trial NCT02864199?

The interventions under investigation include: Ribavirin (DRUG), Peginterferon alfa-2a (DRUG).

Who is sponsoring clinical trial NCT02864199?

This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02864199 being conducted?

This trial has 17 study locations across Alabama, Kansas, Louisiana, Missouri, New York. 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.