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NCT00980330 · ClinicalTrials.gov registry record · Phase 2

A Safety and Effectiveness Study of TMC435 in Chronic, Genotype 1, Hepatitis C Patients Who Failed to Previous Standard Treatment

A Phase 2 study, sponsored by Tibotec Pharmaceuticals, Ireland.

Completed
Registry status
Phase 2
Development phase
463
Enrollment target

NCT00980330 is a Phase 2 study that has completed, run by Tibotec Pharmaceuticals, Ireland. The registered enrollment target is 463 participants.

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The verdict

NCT00980330, a Phase 2 study, has completed, sponsored by Tibotec Pharmaceuticals, Ireland.

COMPLETED
Registry status
Phase 2
Development phase
463 participants
Enrollment target

Study Summary

The purpose of this study is to determine the efficacy, safety and tolerability of different regimens of TMC435 with standard treatment compared to standard treatment alone in participants with chronic, genotype 1, hepatitis C virus (HCV) infection who has failed previous treatment with pegylated interferon (Peg-INF-alfa-2a) and ribavirin (RBV).

Interventions

  • DRUG Placebo
  • DRUG TMC435
  • DRUG Ribavirin (R)
  • DRUG Peg-IFN-alfa-2a (P)

Trial Details

FieldValue
Enrollment Target 463 participants
Start Date 2009-10
Est. Completion 2011-08
Phase Phase 2

Sponsor

Tibotec Pharmaceuticals, Ireland

16 total trials

What the Registry Record Tells You About NCT00980330

The ClinicalTrials.gov registry entry for NCT00980330 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 463 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Tibotec Pharmaceuticals, Ireland, which has 16 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.

NCT00980330 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00980330 about?

NCT00980330 is a clinical study titled "A Safety and Effectiveness Study of TMC435 in Chronic, Genotype 1, Hepatitis C Patients Who Failed to Previous Standard Treatment". The purpose of this study is to determine the efficacy, safety and tolerability of different regimens of TMC435 with standard treatment compared to standard treatment alone in participants with chronic, genotype 1, hepatitis C virus (HCV) infection who has failed previous treatment with pegylated in...

What is the current status of trial NCT00980330?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 463 participants. The study started on 2009-10. Estimated completion is 2011-08.

What interventions are being tested in trial NCT00980330?

The interventions under investigation include: Placebo (DRUG), TMC435 (DRUG), Ribavirin (R) (DRUG), Peg-IFN-alfa-2a (P) (DRUG).

Who is sponsoring clinical trial NCT00980330?

This trial is sponsored by Tibotec Pharmaceuticals, Ireland, which has 16 total clinical trials registered on ClinicalTrials.gov.

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

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.