Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004642
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-02-24
Brief Title:
Phase III Study of Human Anti-Cytomegalovirus CMV Monoclonal Antibody MSL-109 in Newborns With Symptomatic Congenital CMV Infection Without Central Nervous System Disease
Sponsor:
National Center for Research Resources NCRR
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
Phase III Study of Human Anti-Cytomegalovirus CMV Monoclonal Antibody MSL-109 in Newborns With Symptomatic Congenital CMV Infection Without Central Nervous System Disease
Status:
COMPLETED
Status Verified Date:
1999-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
OBJECTIVES I Evaluate the safety tolerance and potential efficacy of 3 doses of human anti-cytomegalovirus CMV monoclonal antibody SDZ MSL-109 MOAB MSL-109 in the treatment of newborns with congenital CMV infection and no central nervous system disease
II Determine the relationship between plasma concentrations of MOAB MSL-109 and therapeutic outcome
III Determine whether MOAB MSL-109 influences the antibody response and clearance of virus from the urine
II Determine the relationship between plasma concentrations of MOAB MSL-109 and therapeutic outcome
III Determine whether MOAB MSL-109 influences the antibody response and clearance of virus from the urine
Detailed Description:
PROTOCOL OUTLINE Patients are treated with human anti-cytomegalovirus monoclonal antibody MSL-109 administered intravenously every other week for a total of 3 doses
Groups of 6 patients are treated at each of 3 MSL-109 doses there is no intrapatient escalation
No concurrent therapy with antibiotics for systemic infection parenteral antifungal agents biological response modifiers or other antiviral agents is allowed
Patients are followed every 2 weeks for 6 weeks every 4 weeks for 12 weeks then annually for 5 years
Groups of 6 patients are treated at each of 3 MSL-109 doses there is no intrapatient escalation
No concurrent therapy with antibiotics for systemic infection parenteral antifungal agents biological response modifiers or other antiviral agents is allowed
Patients are followed every 2 weeks for 6 weeks every 4 weeks for 12 weeks then annually for 5 years
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NIAID-3748 | None | None | None |