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

Lower Respiratory Tract Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00632463
• Other study ID #: ADMA-001
• Status: Completed
• Phase: Phase 2
• First received: March 3, 2008
• Last updated: March 12, 2013
• Start date: February 2008
• Est. completion date: May 2010

Study information

• Verified date: March 2013
• Source: ADMA Biologics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 65 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Infection
• Lower Respiratory Tract Infection
• Respiratory Tract Infections
• Upper Respiratory Tract Infection

Intervention

Biological:
• RI-001
Dose 1
• RI-001
Dose 2
• RI-001
Placebo

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
ADMA Biologics, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Circulating RI-001 Titer	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.	Study day 18	No
Secondary	Incidence of RSV Progression From Symptomatic Upper Respiratory Tract Infection to Lower Respiratory Tract Infection.		Study day 33	No
Secondary	The Number of Patients Achieving at Least a 4-fold Increase in Serum RSV Neutralizing Antibody Titers		18 Days	No