Trial Information
Guidelines to the Intron A® Health Management Program II: A Nursing Support Program for Patients With High-Risk Melanoma Receiving High Dose Intron A Therapy
Inclusion Criteria:
- Signed informed consent
- Age > 18 years
- Confirmed melanoma
- Patient has been prescribed Intron A therapy for High-Risk Stage II & III Melanoma
- Intron A therapy started within 70 days of surgery (additional 15 days may be granted
by the sponsor upon written approval)
- Proper contraception in both male and female subjects and the female partner(s) of
male study subjects
Exclusion Criteria:
- Metastatic disease at the time of diagnosis
- Other malignancies
- History of non compliance to other therapies
- Pregnancy or breast feeding
- Previous Intron A therapy
Type of Study:
Observational
Study Design:
Observational Model: Case-Only, Time Perspective: Prospective
Outcome Measure:
Treatment compliance
Outcome Time Frame:
Assessed during the 1-year treatment
Safety Issue:
No
Authority:
Canada: Health Canada
Study ID:
P04600
NCT ID:
NCT00723710
Start Date:
April 2006
Completion Date:
September 2012
Related Keywords: