RI-001 in Immunosuppressed Respiratory Syncytial Virus (RSV) Infected Patients at Risk of Lower Tract RSV Illness

Completed · Phase 2 · Has a placebo group

Conditions studied: Upper Respiratory Tract Infection, Lower Respiratory Tract Infection

In brief

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.

Key facts

Study ID

NCT00632463

Run by

ADMA Biologics, Inc.

People needed

21

Starts

2008-02-01

Expected to finish

2010-05-01

Last updated by the study team

2013-04-24

Who can join

Age: 2 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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.
• Male/Female patients age: (Pediatric) ≥2 years and <16 years at the time of informed consent.
• Male/Female patients age: (Adult) ≥ 16 years and ≤ 65 years at the time of informed consent.
• Patient must have an URTI as defined by Respiratory Assessment Score (RAS)=1.
• Patients must be actively taking at least one immunosuppressive agent.
• Patients must have a positive RSV RT-PCR at the time of the randomization procedures.
• 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.
• Female patients who are not breast-feeding.
• 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.

You may not qualify if…

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

Where it is running

• University of California San Francisco — San Francisco, California, United States
• University of Colorado Health Sciences Center — Aurora, Colorado, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• All Children's Hospital — St. Petersburg, Florida, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Johns Hopkins Medical Center — Baltimore, Maryland, United States
• New England Medical Center — Boston, Massachusetts, United States
• Hackensack University Medical Center — Hackensack, New Jersey, United States
• Schneider Children's Hospital — New Hyde Park, New York, United States
• University of Rochester Medical Center — Rochester, New York, United States
• Oregon Health and Science University — Portland, Oregon, United States
• Children's Medical Center of Dallas — Dallas, Texas, United States
• Cook Children's Medical Center — Fort Worth, Texas, United States
• Seattle Children's Hospital and Regional Medical Center — Seattle, Washington, United States
• Fred Hutchinson Cancer Research Center — Seattle, Washington, United States
• Alberta Children's Hospital — Calgary, Alberta, Canada
• Hospital for Sick Children — Toronto, Ontario, Canada
• Hopital Maisonneuve Rosemont — Montreal, Quebec, Canada
• Hopital Sainte Justine — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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