Clinical trial NCT00632463: RI-001 in Immunosuppressed Respiratory Syncytial Virus (RSV) Infected Patients at Risk of Lower Tract RSV Illness
Official title: RI-001 in Immunosuppressed Respiratory Syncytial Virus (RSV) Infected Patients at Risk of Lower Tract RSV Illness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Upper Respiratory Tract Infection
Lower Respiratory Tract Infection
Keywords: Transplant
Immunosuppression
Lead sponsor: ADMA Biologics, Inc.
Sponsor class: INDUSTRY
First posted: 2008-03-10
Enrollment: 21
Sex: ALL
Minimum age (years): 2
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: RSV infections can develop into serious, life threatening conditions among immunocompromised patients. The objective of this study (ADMA 001) is to evaluate the safety and efficacy of RI-001 for the prevention of lower respiratory tract infections in immunocompromised patients identified as being infected with RSV in the upper respiratory tract.


Eligibility criteria: Inclusion Criteria:

1. An IEC/IRB approved written informed consent signed and dated by the patient or by parent(s) or a legally acceptable representative. The consent form or a specific assent form, where required, will be signed and dated by minors.
2. Documented Bone Marrow Transplant (BMT)/Hematopoietic Stem Cell Transplant (HSCT), Pulmonary/Cardiac Transplant, Pulmonary Transplant or Liver Transplant within the 2 years prior to randomization to the study drug.
3. Male/Female patients age: (Pediatric) ≥2 years and \<16 years at the time of informed consent.
4. Male/Female patients age: (Adult) ≥ 16 years and ≤ 65 years at the time of informed consent.
5. Patient must have an URTI as defined by Respiratory Assessment Score (RAS)=1.
6. Patients must be actively taking at least one immunosuppressive agent.
7. Patients must have a positive RSV RT-PCR at the time of the randomization procedures.
8. Female patients must be of non-childbearing potential or have a negative pregnancy test prior to study start and be deemed not at risk of becoming pregnant by adherence to a reliable contraceptive method for the duration of the study. Females of non-childbearing potential are defined as women who have had a hysterectomy, bilateral oophorectomy, tubal ligation or who have been post-menopausal for at least two years, or are considered to be sterile due to recent chemotherapy.
9. Female patients who are not breast-feeding.
10. Patient/legally acceptable representative considered as reliable and capable of adhering to the protocol (e.g. able to understand and complete diaries and questionnaires), visit schedules or treatment regimen according to the judgment of the Investigator.

Exclusion Criteria:

1. Documented RSV lower respiratory tract infection (respiratory assessment score is greater than 1) as determined by the site investigators or research staff.
2. Requirement for mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure or other mechanical respiratory or cardiac support
3. Unstable respiratory status so severe that survival is not expected for longer than 6 months.
4. End organ dysfunction resulting in anticipated survival of less than 6 months.
5. Known to be HIV positive.
6. Administration of any RSV specific products, including palivizumab (Synagis®) in the 3 months prior to randomization procedures.
7. Previous, current, or planned administration of an investigational RSV vaccine.
8. Known hypersensitivity to immunoglobulin.
9. Known Immunoglobulin (IgA) deficiency
10. Known renal impairment requiring any form of dialysis (HD, PD, CRRT).
11. Known hemodynamically significant congenital heart disease.
12. Previous poor compliance with visit schedules.
13. Severe medical, neurological or psychiatric disorders or laboratory values which may have an impact on the safety of the patient.
14. Concurrent participation in other investigational drug product studies; any exception must be approved by the ADMA Biologics Medical Director.

Primary outcomes:
measure: Circulating RI-001 Titer
timeFrame: Study day 18
Secondary outcomes:
measure: Incidence of RSV Progression From Symptomatic Upper Respiratory Tract Infection to Lower Respiratory Tract Infection.
timeFrame: Study day 33
measure: The Number of Patients Achieving at Least a 4-fold Increase in Serum RSV Neutralizing Antibody Titers
timeFrame: 18 Days
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Aurora
country: United States
facility: University of Colorado Health Sciences Center
state: Colorado
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: St. Petersburg
country: United States
facility: All Children's Hospital
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Baltimore
country: United States
facility: Johns Hopkins Medical Center
state: Maryland
city: Boston
country: United States
facility: New England Medical Center
state: Massachusetts
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: New Hyde Park
country: United States
facility: Schneider Children's Hospital
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Dallas
country: United States
facility: Children's Medical Center of Dallas
state: Texas
city: Fort Worth
country: United States
facility: Cook Children's Medical Center
state: Texas
city: Seattle
country: United States
facility: Seattle Children's Hospital and Regional Medical Center
state: Washington
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
city: Calgary
country: Canada
facility: Alberta Children's Hospital
state: Alberta
city: Toronto
country: Canada
facility: Hospital for Sick Children
state: Ontario
city: Montreal
country: Canada
facility: Hopital Maisonneuve Rosemont
state: Quebec
city: Montreal
country: Canada
facility: Hopital Sainte Justine
state: Quebec
Study officials:
affiliation: Division of Infectious Diseases, Hospital for Sick Children, Toronto, Ontario, Canada
name: Upton Allen, MBBS
role: PRINCIPAL_INVESTIGATOR
References: