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NCT02116543 · ClinicalTrials.gov registry record · Phase 1

TD-6450 MAD Study in HCV Infected Subjects

A Phase 1 study of Hepatitis C and HCV, sponsored by Theravance Biopharma.

Completed
Registry status
Phase 1
Development phase
47
Enrollment target
1
Study location

NCT02116543 is a Phase 1 study of Hepatitis C and HCV that has completed, run by Theravance Biopharma. The registered enrollment target is 47 participants, below the 1,890-participant average among 106 other Hepatitis C trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT02116543, a Phase 1 study of Hepatitis C and HCV, has completed, sponsored by Theravance Biopharma.

COMPLETED
Registry status
Phase 1
Development phase
47 participants
Enrollment target
1
Study location

Study Summary

This proof of concept study is designed to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of TD-6450 in treatment naïve subjects with GT-1, GT-2 or GT-3 chronic HCV.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG TD-6450

Study Locations (1)

Texas

  • Texas Liver Institute - San Antonio

Trial Details

FieldValue
Enrollment Target 47 participants
Start Date 2014-05
Est. Completion 2014-11
Phase Phase 1

Sponsor

Theravance Biopharma

38 total trials

What the Registry Record Tells You About NCT02116543

The ClinicalTrials.gov registry entry for NCT02116543 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 47 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 Theravance Biopharma, which has 38 total studies on file at ClinicalTrials.gov.

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

NCT02116543 reports 1 study location spanning 1 distinct geographic area - top geographies include Texas.

Frequently Asked Questions

What is clinical trial NCT02116543 about?

NCT02116543 is a clinical study titled "TD-6450 MAD Study in HCV Infected Subjects". This proof of concept study is designed to evaluate the safety, tolerability, pharmacokinetics, and antiviral activity of TD-6450 in treatment naïve subjects with GT-1, GT-2 or GT-3 chronic HCV.

What is the current status of trial NCT02116543?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 47 participants. The study started on 2014-05. Estimated completion is 2014-11.

What conditions does trial NCT02116543 study?

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

What interventions are being tested in trial NCT02116543?

The interventions under investigation include: Placebo (DRUG), TD-6450 (DRUG).

Who is sponsoring clinical trial NCT02116543?

This trial is sponsored by Theravance Biopharma, which has 38 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02116543 being conducted?

This trial has 1 study location across Texas. 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.