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

• ClinicalTrials.gov Identifier: NCT00632463
• Recruitment Status: Completed
• First Posted: March 10, 2008
• Results First Posted: April 24, 2013
• Last Update Posted: April 24, 2013
• Sponsor: ADMA Biologics, Inc.
• Information provided by (Responsible Party): ADMA Biologics, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Upper Respiratory Tract Infection; Lower Respiratory Tract Infection	Biological: RI-001	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 21 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: RI-001 in Immunosuppressed Respiratory Syncytial Virus (RSV) Infected Patients at Risk of Lower Tract RSV Illness
• Study Start Date: February 2008
• Actual Primary Completion Date: May 2010
• Actual Study Completion Date: May 2010

Arms and Interventions

Arm	Intervention/treatment
Experimental: 1; Dose regimen 1	Biological: RI-001; Dose 1
Experimental: 2; Dose regimen 2	Biological: RI-001; Dose 2
Placebo Comparator: 3; Placebo	Biological: RI-001; Placebo

Outcome Measures

Primary Outcome Measures :

1. Circulating RI-001 Titer [ Time Frame: Study day 18 ]
   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.

Secondary Outcome Measures :

1. Incidence of RSV Progression From Symptomatic Upper Respiratory Tract Infection to Lower Respiratory Tract Infection. [ Time Frame: Study day 33 ]
2. The Number of Patients Achieving at Least a 4-fold Increase in Serum RSV Neutralizing Antibody Titers [ Time Frame: 18 Days ]

Eligibility Criteria

• Ages Eligible for Study: 2 Years to 65 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

United States, California

University of California San Francisco

San Francisco, California, United States, 94143

United States, Colorado

University of Colorado Health Sciences Center

Aurora, Colorado, United States, 80045

United States, District of Columbia

Children's National Medical Center

Washington, District of Columbia, United States, 20010

United States, Florida

All Children's Hospital

St. Petersburg, Florida, United States, 33701

United States, Illinois

Rush University Medical Center

Chicago, Illinois, United States, 60612

United States, Maryland

Johns Hopkins Medical Center

Baltimore, Maryland, United States, 21205

United States, Massachusetts

New England Medical Center

Boston, Massachusetts, United States, 02111

United States, New Jersey

Hackensack University Medical Center

Hackensack, New Jersey, United States, 07601

United States, New York

Schneider Children's Hospital

New Hyde Park, New York, United States, 11040

University of Rochester Medical Center

Rochester, New York, United States, 14642

United States, Oregon

Oregon Health and Science University

Portland, Oregon, United States, 97239

United States, Texas

Children's Medical Center of Dallas

Dallas, Texas, United States, 75235

Cook Children's Medical Center

Fort Worth, Texas, United States, 76104

United States, Washington

Seattle Children's Hospital and Regional Medical Center

Seattle, Washington, United States, 98105

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States, 98109

Canada, Alberta

Alberta Children's Hospital

Calgary, Alberta, Canada, T3B6A8

Canada, Ontario

Hospital for Sick Children

Toronto, Ontario, Canada, M5G1X8

Canada, Quebec

Hopital Maisonneuve Rosemont

Montreal, Quebec, Canada, H1T2M4

Hopital Sainte Justine

Montreal, Quebec, Canada, H3T1C5

Sponsors and Collaborators

ADMA Biologics, Inc.

Investigators

• Principal Investigator: Upton Allen, MBBS; Division of Infectious Diseases, Hospital for Sick Children, Toronto, Ontario, Canada

More Information

• Responsible Party: ADMA Biologics, Inc.
• ClinicalTrials.gov Identifier: NCT00632463
• Other Study ID Numbers: ADMA-001
• First Posted: March 10, 2008
• Results First Posted: April 24, 2013
• Last Update Posted: April 24, 2013
• Last Verified: March 2013

Keywords provided by ADMA Biologics, Inc.:

Transplant; Immunosuppression

Additional relevant MeSH terms:

Infections; Communicable Diseases; Respiratory Tract Infections; Disease Attributes; Pathologic Processes; Respiratory Tract Diseases