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| Sponsor: | National Center for Research Resources (NCRR) |
|---|---|
| Collaborator: |
National Institute of Allergy and Infectious Diseases (NIAID) |
| Information provided by: | Office of Rare Diseases (ORD) |
| ClinicalTrials.gov Identifier: | NCT00004642 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cytomegalovirus Infections |
Drug: SDZ MSL-109 |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Phase I/II Study of Human Anti-Cytomegalovirus (CMV) Monoclonal Antibody MSL-109 in Newborns With Symptomatic Congenital CMV Infection Without Central Nervous System Disease |
| Study Start Date: | February 1995 |
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.
Eligibility| Ages Eligible for Study: | up to 29 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics-- Symptomatic congenital cytomegalovirus (CMV) infection confirmed by urine culture No CMV acquired natally or postnatally Normal eye exam and skull x-ray, computerized tomography, or magnetic resonance imaging No evidence of central nervous system CMV, e.g.: Microcephaly, hydrocephaly, or hydranencephaly Intracranial calcification Chorioretinitis Normal cerebrospinal fluid Preterm: WBC no greater than 30 Protein less than 120 mg/dL Term: WBC no greater than 25 Protein less than 80 mg/dL --Prior/Concurrent Therapy-- At least 2 weeks since investigational drugs No prior or concurrent antiviral agents --Patient Characteristics-- Life expectancy: No imminent demise Renal: Creatinine no greater than 1.5 mg/dL Other: Birth weight at least 1200 g No congenital toxoplasmosis, congenital rubella, or syphilis No active systemic infection, i.e.: Bacterial Non-CMV viral, including HIV Protozoal Fungal No severe concurrent clinical condition, e.g.: Non-CMV congenital disease Genetic abnormality Moderate to severe hyaline membrane disease
Contacts and Locations More Information
| Study ID Numbers: | 199/11673, NIAID-3748 |
| Study First Received: | February 24, 2000 |
| Last Updated: | June 23, 2005 |
| ClinicalTrials.gov Identifier: | NCT00004642 History of Changes |
| Health Authority: | United States: Federal Government |
|
congenital cytomegalovirus infection cytomegalovirus infection herpesvirus infection immunologic disorders and infectious disorders |
neonatal disorders rare disease viral infection |
|
Antibodies, Monoclonal Virus Diseases Communicable Diseases Immunologic Factors Physiological Effects of Drugs Nervous System Diseases |
Cytomegalovirus Infections Central Nervous System Diseases DNA Virus Infections Infection Pharmacologic Actions Herpesviridae Infections |
