CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 299 enrolled
Drug / intervention
Intron A (interferon alfa-2b; SCH 30500)biological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00723710
NCT00723710N/ACompleted
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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

Merck Sharp & Dohme LLC·observational·Posted Jul 29, 2008·Updated Aug 26, 2015

In Brief

An observational study evaluating Intron A (interferon alfa-2b; SCH 30500) for Melanoma. Completed, enrolled 299 participants.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsMelanoma
Countries--
Collaborators--

Timeline

N/ACompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 29, 2008
Enrollment StartApr 1, 2006
Primary CompletionSep 1, 2012
TodayJul 2, 2026
Enrollment to primary: 6.4 yearsPosted 17.9 years ago

Interventions

Intron A (interferon alfa-2b; SCH 30500)biological

The recommended regimen includes an induction treatment of 5 consecutive days per week for 4 weeks as a 20-minute intravenous (iv) infusion at a dose of 20 million international units per square meter (MIU/m\^2). The induction treatment should be followed by a maintenance treatment of 3 times per week for 48 weeks as a subcutaneous (sc) injection at a dose of 10 MIU/m\^2. Therapy should be administered for a total of one year unless the disease progresses or the treatment has lead to recurrent unmanageable serious adverse effects.