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Effect of Proactive Management of Side Effects on Treatment Compliance in Malignant Melanoma Patients on High-dose Intron A Therapy (Study P04600)

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Melanoma

Intervention: Intron A (interferon alfa-2b; SCH 30500) (Biological)

Phase: N/A

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Summary

Patients with malignant melanoma who had undergone surgery will receive adjuvant treatment with high-dose Intron A for one year. The objective of this study is to maximize treatment compliance by proactive management of side effects in a day-to-day healthcare setting.

Clinical Details

Official title: Guidelines to the Intron AŽ Health Management Program II: A Nursing Support Program for Patients With High-Risk Melanoma Receiving High Dose Intron A Therapy

Study design: Observational Model: Case-Only, Time Perspective: Prospective

Primary outcome: Number of Participants Who Completed Treatment

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Additional Information

Starting date: April 2006
Last updated: June 1, 2015

Page last updated: August 23, 2015

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