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

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Number, type, severity, and association of treatment emergent adverse events.

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
Theravance Biopharma

38 total trials

What the finished NCT02116543 record still lists

NCT02116543 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 47 participants, a relatively small participant target, below the 1,890-participant average among 106 other Hepatitis C trials with a reported enrollment target (98% lower).

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 a single indexed study location in 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.

Similar trials for Hepatitis C

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT02116543's enrollment target sits among peer trials

47 76th of 106 higher than 30 of 106 other Hepatitis C trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Hepatitis C trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02116543, the US trial registry maintained by the National Library of Medicine. NCT02116543 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.