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

Phase 2
2 Years
65 Years
Not Enrolling
Upper Respiratory Tract Infection, Lower Respiratory Tract Infection

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Trial Information

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

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

4. Male/Female patients age: (Adult) ≥ 16 years and ≤ 65 years at the time of informed

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

3. Unstable respiratory status so severe that survival is not expected for longer than 6

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.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Outcome Measure:

Circulating RI-001 Titer

Outcome Description:

The primary endpoint of this study was the mean fold titer increase from baseline to Day 18 in circulating serum anti-RSV neutralizing antibody following treatment with RI-001.

Outcome Time Frame:

Study day 18

Safety Issue:


Principal Investigator

Upton Allen, MBBS

Investigator Role:

Principal Investigator

Investigator Affiliation:

Division of Infectious Diseases, Hospital for Sick Children, Toronto, Ontario, Canada


United States: Food and Drug Administration

Study ID:




Start Date:

February 2008

Completion Date:

May 2010

Related Keywords:

  • Upper Respiratory Tract Infection
  • Lower Respiratory Tract Infection
  • Transplant
  • Immunosuppression
  • Respiratory Tract Infections



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