INSIGHT - Post Marketing Surveillance

Carcinoma, Hepatocellular Clinical Trial

— INSIGHT  

Official title:

International Study With Nexavar About Safety and Efficacy in Carcinoma Hepatocellular Therapy (HCC)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00792350
• Other study ID #: 14690
• Secondary ID: 1341913420NX0801
• Status: Completed
• Phase: N/A
• First received: November 14, 2008
• Last updated: May 13, 2014
• Start date: April 2008
• Est. completion date: April 2014

Study information

• Verified date: May 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesAustria: Ethikkommission
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 791
• Est. completion date: April 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Exclusion criteria must be read in conjunction with the local product information

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular

Intervention

Drug:
• Sorafenib (Nexavar, BAY43-9006)
Treatment of Hepatocellular Carcinoma with Nexavar (HCC)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

Austria,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy: status of tumor, patients performance status		At each follow-up visit, every 2-4 months	No
Secondary	Duration of treatment		At each follow-up visit, every 2-4 months	No
Secondary	Time of survival		At each follow-up visit, every 2-4 months	No
Secondary	Reports of adverse events		At each follow-up visit, every 2-4 months	Yes

External Links

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