Full Text View
Tabular View
No Study Results Posted
Related Studies
RI-001 in Immunosuppressed Respiratory Syncytial Virus (RSV) Infected Patients at Risk of Lower Tract RSV Illness
This study is currently recruiting participants.
Verified by ADMA Biologics, Inc., February 2009
First Received: March 3, 2008   Last Updated: February 5, 2009   History of Changes
Sponsored by: ADMA Biologics, Inc.
Information provided by: ADMA Biologics, Inc.
ClinicalTrials.gov Identifier: NCT00632463
  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 II

Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Parallel Assignment
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 ]

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 ]

Estimated Enrollment: 30
Study Start Date: February 2008
Estimated Study Completion Date: May 2009
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Dose regimen 1
Biological: RI-001
Dose 1
2: Experimental
Dose regimen 2
Biological: RI-001
Dose 2
3: Placebo Comparator
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00632463

Contacts
Contact: Mark D Sorrentino, MD MS 201 478-5552 sorrentinom@admabio.com

  Show 20 Study Locations
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 ( Mark Sorrentino, MD, MS, Chief Medical Officer )
Study ID Numbers: ADMA-001
Study First Received: March 3, 2008
Last Updated: February 5, 2009
ClinicalTrials.gov Identifier: NCT00632463     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by ADMA Biologics, Inc.:
Transplant
Immunosuppression

Study placed in the following topic categories:
Virus Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

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

ClinicalTrials.gov processed this record on September 10, 2009