INSIGHT - Post Marketing Surveillance

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

791 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-04-30

Study Completion Date

2014-04-30

Brief Summary

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In this international non-interventional post-marketing surveillance study we want to evaluate patient characteristics in HCC patients as well as efficacy and safety of Sorafenib (Nexavar®) treatment under daily-life treatment conditions. Specifically investigated are the tumor status, prior and/ or concomitant surgical, radiological and drug treatment and the duration of Sorafenib treatment.

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Detailed Description

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Conditions

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Carcinoma, Hepatocellular

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Sorafenib (Nexavar, BAY43-9006)

Intervention Type DRUG

Treatment of Hepatocellular Carcinoma with Nexavar (HCC)

Interventions

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Sorafenib (Nexavar, BAY43-9006)

Treatment of Hepatocellular Carcinoma with Nexavar (HCC)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* In- and outpatients with diagnosis of hepatocellular carcinoma (HCC) and decision taken by the investigator to prescribe Nexavar

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Many Locations, , Austria

Site Status

Many Locations, , Germany

Site Status

Countries

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Austria Germany