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NCT01168856 · ClinicalTrials.gov registry record

An Observational Study on Long-Term Persistence of Resistant Mutations And Durability of Sustained Virological Response in Patients With Chronic Hepatitis C Treated With Direct Acting Antiviral (DAA)- Containing Regimens

A clinical trial, sponsored by Hoffmann-La Roche.

Terminated
Registry status
734
Enrollment target

NCT01168856: Clinical Trial study, sponsored by Hoffmann-La Roche.

NCT01168856 is a clinical trial that was terminated before completion, run by Hoffmann-La Roche. The registered enrollment target is 734 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01168856 was terminated before completion, sponsored by Hoffmann-La Roche.

TERMINATED
Registry status
734 participants
Enrollment target

Study Summary

This observational long-term follow-up study will assess the persistence of direct acting antiviral (DAA) resistant mutations and the durability of sustained virological response in patients with chronic hepatitis C who have participated in a Roche DAA treatment protocol. Up to 5 scheduled monitoring visits for blood sampling during an observational period of up to 36 months.

Primary Outcome

Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 International Units per milliliter \[IU/mL\]).

Trial Details

FieldValue
Enrollment Target 734 participants
Start Date 2010-09
Est. Completion 2015-04
Hoffmann-La Roche

909 total trials

Why NCT01168856 stopped before completion

NCT01168856 is an observational study that tracks outcomes without assigning an intervention. The registered 734 participants enrollment target is mid-sized for trials with a published cap.

The record links to 0 conditions, and to 0 interventions.

NCT01168856 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01168856 about?

NCT01168856 is a clinical study titled "An Observational Study on Long-Term Persistence of Resistant Mutations And Durability of Sustained Virological Response in Patients With Chronic Hepatitis C Treated With Direct Acting Antiviral (DAA)- Containing Regimens". This observational long-term follow-up study will assess the persistence of direct acting antiviral (DAA) resistant mutations and the durability of sustained virological response in patients with chronic hepatitis C who have participated in a Roche DAA treatment protocol. Up to 5 scheduled monitorin...

What is the current status of trial NCT01168856?

This trial is currently terminated. The enrollment target is 734 participants. The study started on 2010-09. Estimated completion is 2015-04.

Who is sponsoring clinical trial NCT01168856?

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

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Source: ClinicalTrials.gov NCT01168856, the US trial registry maintained by the National Library of Medicine. NCT01168856 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.