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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

Primary Purpose

Cytomegalovirus Infections

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
SDZ MSL-109
Sponsored by
National Center for Research Resources (NCRR)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cytomegalovirus Infections focused on measuring congenital cytomegalovirus infection, cytomegalovirus infection, herpesvirus infection, immunologic disorders and infectious disorders, neonatal disorders, rare disease, viral infection

Eligibility Criteria

0 Years - 29 Days (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    February 24, 2000
    Last Updated
    June 23, 2005
    Sponsor
    National Center for Research Resources (NCRR)
    Collaborators
    National Institute of Allergy and Infectious Diseases (NIAID)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00004642
    Brief 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
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    March 1999
    Overall Recruitment Status
    Completed
    Study Start Date
    February 1995 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Center for Research Resources (NCRR)
    Collaborators
    National Institute of Allergy and Infectious Diseases (NIAID)

    4. Oversight

    5. Study Description

    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cytomegalovirus Infections
    Keywords
    congenital cytomegalovirus infection, cytomegalovirus infection, herpesvirus infection, immunologic disorders and infectious disorders, neonatal disorders, rare disease, viral infection

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    SDZ MSL-109

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    0 Years
    Maximum Age & Unit of Time
    29 Days
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Richard J. Whitley
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    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

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