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

NCT00632463 | Completed Phase 2 Results DMC

• 1 other identifier: ADMA-001
• Study Type: interventional
• Target: 21
• Locations: 2 countries
• Sites: 19

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.

Conditions

Upper Respiratory Tract Infection; Lower Respiratory Tract Infection

Keywords

Transplant; Immunosuppression

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Incidence of RSV Progression From Symptomatic Upper Respiratory Tract Infection to Lower Respiratory Tract Infection.

  Study day 33

• The Number of Patients Achieving at Least a 4-fold Increase in Serum RSV Neutralizing Antibody Titers

  18 Days

Study Arms (3)

1

EXPERIMENTAL

Dose regimen 1

Biological: RI-001

2

EXPERIMENTAL

Dose regimen 2

Biological: RI-001

3

PLACEBO COMPARATOR

Placebo

Biological: RI-001

Interventions

RI-001 BIOLOGICAL

Dose 1

1

Eligibility Criteria

• Age: 2 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• Male/Female patients age: (Pediatric) ≥2 years and \<16 years at the time of informed consent.
• Male/Female patients age: (Adult) ≥ 16 years and ≤ 65 years at the time of informed consent.
• Patient must have an URTI as defined by Respiratory Assessment Score (RAS)=1.
• Patients must be actively taking at least one immunosuppressive agent.
• Patients must have a positive RSV RT-PCR at the time of the randomization procedures.
• 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.
• Female patients who are not breast-feeding.
• 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.

You may not qualify if:

• Documented RSV lower respiratory tract infection (respiratory assessment score is greater than 1) as determined by the site investigators or research staff.
• Requirement for mechanical ventilation, extracorporeal membrane oxygenation, continuous positive airway pressure or other mechanical respiratory or cardiac support
• Unstable respiratory status so severe that survival is not expected for longer than 6 months.
• End organ dysfunction resulting in anticipated survival of less than 6 months.
• Known to be HIV positive.
• Administration of any RSV specific products, including palivizumab (Synagis®) in the 3 months prior to randomization procedures.
• Previous, current, or planned administration of an investigational RSV vaccine.
• Known hypersensitivity to immunoglobulin.
• Known Immunoglobulin (IgA) deficiency
• Known renal impairment requiring any form of dialysis (HD, PD, CRRT).
• Known hemodynamically significant congenital heart disease.
• Previous poor compliance with visit schedules.
• Severe medical, neurological or psychiatric disorders or laboratory values which may have an impact on the safety of the patient.
• Concurrent participation in other investigational drug product studies; any exception must be approved by the ADMA Biologics Medical Director.

Sponsors & Collaborators

• ADMA Biologics, Inc.: lead

Study Sites (19)

University of California San Francisco

San Francisco, California, 94143, United States

Location

University of Colorado Health Sciences Center

Aurora, Colorado, 80045, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

All Children's Hospital

St. Petersburg, Florida, 33701, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Johns Hopkins Medical Center

Baltimore, Maryland, 21205, United States

Location

New England Medical Center

Boston, Massachusetts, 02111, United States

Location

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

Schneider Children's Hospital

New Hyde Park, New York, 11040, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

Children's Medical Center of Dallas

Dallas, Texas, 75235, United States

Location

Cook Children's Medical Center

Fort Worth, Texas, 76104, United States

Location

Seattle Children's Hospital and Regional Medical Center

Seattle, Washington, 98105, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

Alberta Children's Hospital

Calgary, Alberta, T3B6A8, Canada

Location

Hospital for Sick Children

Toronto, Ontario, M5G1X8, Canada

Location

Hopital Maisonneuve Rosemont

Montreal, Quebec, H1T2M4, Canada

Location

Hopital Sainte Justine

Montreal, Quebec, H3T1C5, Canada

Location

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Limitations and Caveats

Unfortunately enrollment in this study was suspended early due to slow accrual rates.

Results Point of Contact

• Title: Chief Medical Officer
• Organization: ADMA Biologics

agrossman@admabio.com

201-478-5552

Study Officials

• Upton Allen, MBBS

  Division of Infectious Diseases, Hospital for Sick Children, Toronto, Ontario, Canada

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2008
• First Posted: March 10, 2008
• Study Start: February 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: April 24, 2013
• Results First Posted: April 24, 2013

Record last verified: 2013-03

Locations

US (15); CA (4)