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A Study To Compare The Effects Of The Infusion Of A Sepsis Drug Between Healthy Adults And Adults With Damaged Livers

NCT ID: NCT00158769

Last Updated: 2017-09-25

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

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2005-10-26

Brief Summary

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This compound, GR270773, is a lipid based compound being developed to treat Sepsis. Lipids are broken down in the body by the liver. This study is designed to see whether the effect of the drug in people with poorly functioning livers is any different to the effect on healthy adults.

Detailed Description

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Conditions

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Sepsis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Subjects with moderate hepatic impairment

Subjects with moderate hepatic impairment as defined by a Child-Pugh score of 7-9 will be included. Subjects will be given GR270773 as a loading infusion of 25 milligram per kilogram per hour (mg/kg/hr) for 2 hours followed by a maintenance infusion of 5 mg/kg/hr for 70 hours.

Group Type EXPERIMENTAL

Intravenous GR270773 - Phospholipid emulsion

Intervention Type DRUG

GR270773 (lipid emulsion) is a sterile, white to off-white, semi-translucent liquid for intravenous injection.

Healthy subjects

Subjects will be matched as closely as possible to the group of moderate hepatic subjects for gender, age and body mass index (BMI). Subjects will be administered 25 mg/kg/hr GR270773 as a loading dose for 2 hours followed by a maintenance infusion of 5 mg/kg/hr for 70 hours. Following a washout period of 21 days, the subjects will then receive a loading dose of 75 mg/kg/hr for 2 hours followed by a maintenance dose of 12.5 mg/kg/hr of GR270773 for 70 hours.

Group Type EXPERIMENTAL

Intravenous GR270773 - Phospholipid emulsion

Intervention Type DRUG

GR270773 (lipid emulsion) is a sterile, white to off-white, semi-translucent liquid for intravenous injection.

Interventions

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Intravenous GR270773 - Phospholipid emulsion

GR270773 (lipid emulsion) is a sterile, white to off-white, semi-translucent liquid for intravenous injection.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with known history of liver disease (either with or without history of alcohol abuse).
* Previous confirmation of liver cirrhosis by liver biopsy or other medical imaging technique.
* Child-Pugh score of 7-9 (moderate impairment) BMI 19-29 Kg/m2.
* Healthy volunteers to match the hepatically impaired subjects in a 1:1 ratio by gender, age, BMI.

Exclusion Criteria

* Lactating or pregnant females.
* Subjects with BP \> 160/90.
* Subjects who, within the past six months, have had a history of significant drug or alcohol abuse, or any indication of regular use of more than 14 units of alcohol per week for women, or 21 units/week for men.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Bratislava, , Slovakia

Site Status

Countries

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Slovakia

Other Identifiers

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EMD10007

Identifier Type: -

Identifier Source: org_study_id