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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

NCT00004642 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2005-06-24

No results posted yet for this study

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.

Conditions

  • Cytomegalovirus Infections

Interventions

DRUG

SDZ MSL-109

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    collaborator NIH

  • National Center for Research Resources (NCRR)

    lead NIH

Principal Investigators

  • Richard J. Whitley

Study Design

Purpose
TREATMENT

Eligibility

Min Age
0 Years
Max Age
29 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1995-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00004642 on ClinicalTrials.gov