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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Information provided by (Responsible Party):
ADMA Biologics, Inc.

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

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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

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




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 ]


Information from the National Library of Medicine

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00632463


Locations
Show Show 19 study locations
Sponsors and Collaborators
ADMA Biologics, Inc.
Investigators
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Principal Investigator: Upton Allen, MBBS Division of Infectious Diseases, Hospital for Sick Children, Toronto, Ontario, Canada
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Responsible Party: ADMA Biologics, Inc.
ClinicalTrials.gov Identifier: NCT00632463    
Other Study ID Numbers: ADMA-001
First Posted: March 10, 2008    Key Record Dates
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:
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Infection
Communicable Diseases
Respiratory Tract Infections
Respiratory Tract Diseases