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An Open-label, Single-Arm Study to Evaluate the Safety and Rabies Virus Antibody Titers of Intramuscularly Administered Rabies Immune Globulin (Human)

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ClinicalTrials.gov Identifier: NCT02139657
Recruitment Status : Completed
First Posted : May 15, 2014
Last Update Posted : July 24, 2014
Sponsor:
Information provided by (Responsible Party):
Grifols Therapeutics LLC

Study Description
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Brief Summary:
This is a single-arm, open-label study of Rabies Immune Globulin (Human), Caprylate/Chromatography Purified (RIG-C), in approximately 12 healthy subjects. The purpose of this study is to characterize the rabies virus-specific antibody titer after a single intramuscular injection of 20 IU/kg RIG-C and to evaluate the safety and tolerability of RIG-C.

Condition or disease Intervention/treatment Phase
Rabies Biological: RIG-C Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Single-arm Study to Evaluate the Safety and Antibody Titers Specific to the Rabies Virus in Healthy Subjects After Receiving a Single Dose of Intramuscularly Administered Rabies Immune Globulin (Human)
Study Start Date : March 2014
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Rabies

Arms and Interventions
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Arm Intervention/treatment
Experimental: RIG-C
Single 20 IU/kg dose of RIG-C by intramuscular injection
 Biological: RIG-C
Other Name: Rabies Immune Globulin (Human), Caprylate/Chromatography Purified


Outcome Measures
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Primary Outcome Measures :
  1. Rabies Virus Antibody Titer [ Time Frame: 10 days post-RIG-C dosing ]

Secondary Outcome Measures :
  1. Number of subjects who discontinue due to adverse events [ Time Frame: 21 days ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • In good health in the judgment of the Investigator as determined by medical history, physical examination, and screening laboratory assessments.
  • Female of childbearing potential must have a negative result on the screening serum pregnancy test and must agree to practice contraception by a method of proven reliability (includes abstinence) for the duration of the study.

Exclusion Criteria:

  • Pregnant or lactating females.
  • Clinical evidence of any significant acute or chronic disease that may interfere with successful completion of the trial.
  • Clinically significant history of the following: cardiovascular disease, hyperlipidemia, serious respiratory disease including bronchitis or asthma, endocrine disorder, liver disease, glaucoma, gastrointestinal disease, disorder of the reticuloendothelial system, or neurologic illness.
  • History of angioedema or nephrotic syndrome.
  • Non-controlled arterial hypertension.
  • Anemia at screening.
  • Significant proteinuria (> 1 + on urine dipstick) and/or has a history of acute renal failure and/or severe renal impairment or a blood urea nitrogen or creatinine more than 2.5 times the upper limit of normal at screening and/or currently receiving dialysis.
  • Elevated liver enzymes (aspartate transaminase, alanine aminotransferase) and Gamma-glutamyl Transferase) equal to or greater than 1.5 times the upper limit at screening.
  • Previously received the rabies vaccine and/or rabies immune globulin.
  • Received infusion of a blood/plasma product or fraction within the past 12 months, including any type of immune globulin.
  • Known adverse reaction to administration of any immune globulin or other blood/plasma products.
  • Experienced anaphylactic shock with the administration of blood/plasma products.
  • Known medical history of selective immunoglobulin A (IgA) deficiency.
  • Received any corticosteroids, immunosuppressants, or immunomodulators within 6 weeks prior to screening.
  • Expects to receive oral or topical non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen, antihypertensives, and/or antihistamines 24 hours before or after investigational product administration during the Baseline/Treatment, Study Day 0 visit.
  • Currently receiving any anti-viral treatment.
  • Screening laboratory results indicative of an acute or chronic infection with hepatitis A virus (HAV), hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV), or parvovirus B19 (B19V).
  • Participated in another clinical trial within 30 days prior to screening (imaging studies without investigative treatments are permitted) or has received any investigational products within the previous 3 months.
  • Not willing to postpone receiving any live virus vaccines until 3 months after receiving investigational product.
  • History of a psychiatric illness requiring hospitalization.
  • Known substance or prescription drug abuse in the past 12 months.
  • Any active medical illness that the Investigator may consider a potential confounding condition that would interfere with the study visits and/or procedures.
Contacts and Locations
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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): NCT02139657


Locations
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United States, Arizona
Tempe, Arizona, United States, 85283
Sponsors and Collaborators
Grifols Therapeutics LLC
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Grifols Therapeutics LLC
ClinicalTrials.gov Identifier: NCT02139657    
Other Study ID Numbers: GTI1301
First Posted: May 15, 2014    Key Record Dates
Last Update Posted: July 24, 2014
Last Verified: July 2014
Keywords provided by Grifols Therapeutics LLC:
Rabies
Rabies virus
Rhabdoviridae
 Rabies immune globulin
Rabies antibodies
Passive rabies immunization
Additional relevant MeSH terms:
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Rabies
Rhabdoviridae Infections
Mononegavirales Infections
RNA Virus Infections
 Virus Diseases
Immunoglobulins
Immunologic Factors
Physiological Effects of Drugs