Treatment of CML, MM or RCC.
Conditions
Interventions
Trade Name: PEG-IFN (Pegasys)
Product Name: PEG-IFN (Pegasys)
Pharmaceutical Form: Solution for injection
Trade Name: ROFERON-A 3 MUI
ROFERON-A 4,5 MUI
ROFERON-A 6 MUI
ROFERON-A 9 MUI
ROFERON-A 18 MU
Sponsors
F. Hoffmann-La Roche Ltd
Eligibility
Inclusion criteria
Inclusion criteria: - Patients must have completed protocol NO15753, NO15764, NO16006 or NO16007 and responded to treatment at the end of the trial as defined in the parent protocol. - CML patients must have a confirmed cytogenetic complete response within 2 months of entering the extension study. MM and RCC patients must have tumour assessments verifying stable or better response within 2 months of entering the extension study. - Provide written informed consent. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Pregnant or lactating women. - Fertile men or women of childbearing potential unless (1) surgically sterile or (2) using adequate measures of contraception such as oral contraceptives, intrauterine device or barrier method of contraception in conjunction with spermicidal jelly.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To allow patients who have responded to treatment with PEG-IFN or Roferon-A in prior clinical protocols the opportunity to continue with study drug. - To monitor safety in terms of serious adverse events (SAEs).;Secondary Objective: ;Primary end point(s): No formal analysis of the data is planned for this extension treatment protocol. | — |
Countries
Spain
Outcome results
None listed