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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ADMA Biologics, Inc.
ClinicalTrials.gov Identifier:
NCT00632463
First received: March 3, 2008
Last updated: March 12, 2013
Last verified: March 2013
  Purpose

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 Intervention Phase
Upper Respiratory Tract Infection
Lower Respiratory Tract Infection
Biological: RI-001
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: RI-001 in Immunosuppressed Respiratory Syncytial Virus (RSV) Infected Patients at Risk of Lower Tract RSV Illness

Further study details as provided by ADMA Biologics, Inc.:

Primary Outcome Measures:
  • Circulating RI-001 Titer [ Time Frame: Study day 18 ] [ Designated as safety issue: No ]
    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:
  • Incidence of RSV Progression From Symptomatic Upper Respiratory Tract Infection to Lower Respiratory Tract Infection. [ Time Frame: Study day 33 ] [ Designated as safety issue: No ]
  • The Number of Patients Achieving at Least a 4-fold Increase in Serum RSV Neutralizing Antibody Titers [ Time Frame: 18 Days ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: February 2008
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   2 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00632463

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 Sainte Justine
Montreal, Quebec, Canada, H3T1C5
Hopital Maisonneuve Rosemont
Montreal, Quebec, Canada, H1T2M4
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

No publications provided

Responsible Party: ADMA Biologics, Inc.
ClinicalTrials.gov Identifier: NCT00632463     History of Changes
Other Study ID Numbers: ADMA-001
Study First Received: March 3, 2008
Results First Received: February 22, 2013
Last Updated: March 12, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by ADMA Biologics, Inc.:
Transplant
Immunosuppression

Additional relevant MeSH terms:
Communicable Diseases
Infection
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 21, 2014