A Follow-up Evaluation for Safety in Subjects Who Participated in a Phase 1 Study With BMS-986094 (INX-08189)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

113 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-11-30

Study Completion Date

2014-06-30

Brief Summary

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The purpose of this study is to determine the rate of kidney or heart impairment, if any, in subjects who received BMS-986094 (INX-08189) in Phase 1 clinical trials

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Detailed Description

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Conditions

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Healthy Hepatitis C

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Subjects treated with BMS-986094/INX-08189

Subjects who participated in a clinical trial in which at least 1 dose of BMS-986094/INX-08189 was administered

BMS-986094/INX-08189

Intervention Type DRUG

Subjects treated with Placebo matching BMS-986094/INX-08189

Subjects who participated in a clinical trial in which at least 1 dose of Placebo matching BMS-986094/INX-08189 was administered

Placebo matching BMS-986094/INX-08189

Intervention Type DRUG

Interventions

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BMS-986094/INX-08189

Intervention Type DRUG

Placebo matching BMS-986094/INX-08189

Intervention Type DRUG

Other Intervention Names

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Observational study - No Intervention subjects were previously treated with BMS-986094/INX-08189 Observational study - No Intervention subjects were previously treated with Placebo matching BMS-986094/INX-08189

Eligibility Criteria

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Inclusion Criteria

* Healthy and hepatitis C virus (HCV)-infected subjects who participated in prior Phase 1 trial with BMS-986094/INX-08189 and:

1. Received at least 1 dose of INX-08189 or
2. Received placebo in studies for HCV-infected subjects (INH-189-002 or INH-189-006)
* Age 18 or older