| Exclusion Criteria: | 1) Pregnant or nursing women.
2) Suspected hypersensitivity to interferon alpha.
3) Participation in another clinical trial or use of any investigational drug within 30 days prior to study entry.
4) Subjects with organ transplants.
5) Any known preexisting medical condition that could interfere with the subject's participation in and completion of the study: a) History of psychosis or presence of poorly controlled depression; b) CNS trauma or active seizure disorders requiring medication; c) Significant cardiovascular dysfunction within the past 6 months including symptomatic cardiac ischemia, arrhythmia or congestive heart failure requiring hospitalization or emergancy room visit;
6) (Continued from No. 5) - d) Poorly controlled diabetes mellitus (HbA(subscript 1) C >10.0%); e) Unstable pulmonary disease requiring hospitalization or emergency room visit within the last 3 months; f) Immunologically mediated disease (eg, rheumatoid arthritis, autoimmune hepatitis, immune mediated glomerulonephritis).
7) Donation of blood within the preceding 60 days.
8) Any other condition that, in the opinion of the investigator, would make the subject unsuitable for enrollment or could interfere with the subject participating in and completing the protocol.
9) History of any clinically significant local or systemic infectious disease within 4 weeks prior to initial treatment administration.
10) Untreated bladder infection.
11) Female subjects who are not surgically sterilized, not at least 1 year postmenopausal, or not established on adequate contraception (eg, IUD, condom plus spermicide, diaphragm, or cervical cap plus spermicide) or medical contraception during the study and for at least 1 month prior to drug administration and after study participation.
12) Positive for hepatitis BsAg or HIV Ab or hepatitis C.
13) Immunosuppressive therapy within the last 3 months.
14) Subjects who are part of the staff personnel directly involved with this study.
15) Subjects who are family members of the investigation study staff.
16) BCG therapy or intravesical therapy within 3 months.
17) Traumatic catheterization within 1 month. |