Trial Condition(s):
Carcinoma, Hepatocellular
INSIGHT - Post Marketing Surveillance (INSIGHT)
Bayer Identifier:
14690
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many Locations, Germany | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Austria | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
International Study with Nexavar about safety and efficacy in Carcinoma Hepatocellular therapy (HCC)
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Efficacy: status of tumor, patients performance statusTimeframe: At each follow-up visit, every 2-4 months
Secondary Outcome
- Duration of treatmentTimeframe: At each follow-up visit, every 2-4 months
- Time of survivalTimeframe: At each follow-up visit, every 2-4 months
- Reports of adverse eventsTimeframe: At each follow-up visit, every 2-4 months
Additional Information
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