Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2026-02-25 @ 4:17 AM
Study NCT ID:
NCT02139657
Status:
COMPLETED
Last Update Posted:
2014-07-24
First Post:
2014-04-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Open-label, Single-Arm Study to Evaluate the Safety and Rabies Virus Antibody Titers of Intramuscularly Administered Rabies Immune Globulin (Human)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011818', 'term': 'Rabies'}], 'ancestors': [{'id': 'D018353', 'term': 'Rhabdoviridae Infections'}, {'id': 'D018701', 'term': 'Mononegavirales Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002210', 'term': 'Caprylates'}], 'ancestors': [{'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-07-22', 'studyFirstSubmitDate': '2014-04-28', 'studyFirstSubmitQcDate': '2014-05-13', 'lastUpdatePostDateStruct': {'date': '2014-07-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rabies Virus Antibody Titer', 'timeFrame': '10 days post-RIG-C dosing'}], 'secondaryOutcomes': [{'measure': 'Number of subjects who discontinue due to adverse events', 'timeFrame': '21 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Rabies', 'Rabies virus', 'Rhabdoviridae', 'Rabies immune globulin', 'Rabies antibodies', 'Passive rabies immunization'], 'conditions': ['Rabies']}, 'referencesModule': {'references': [{'pmid': '29983597', 'type': 'DERIVED', 'citation': 'Hanna K, Cruz MC, Mondou E, Corsi E, Vandeberg P. Safety and neutralizing rabies antibody in healthy subjects given a single dose of rabies immune globulin caprylate/chromatography purified. Clin Pharmacol. 2018 Jun 26;10:79-88. doi: 10.2147/CPAA.S166454. eCollection 2018.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* In good health in the judgment of the Investigator as determined by medical history, physical examination, and screening laboratory assessments.\n* 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.\n\nExclusion Criteria:\n\n* Pregnant or lactating females.\n* Clinical evidence of any significant acute or chronic disease that may interfere with successful completion of the trial.\n* 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.\n* History of angioedema or nephrotic syndrome.\n* Non-controlled arterial hypertension.\n* Anemia at screening.\n* 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.\n* Elevated liver enzymes (aspartate transaminase, alanine aminotransferase) and Gamma-glutamyl Transferase) equal to or greater than 1.5 times the upper limit at screening.\n* Previously received the rabies vaccine and/or rabies immune globulin.\n* Received infusion of a blood/plasma product or fraction within the past 12 months, including any type of immune globulin.\n* Known adverse reaction to administration of any immune globulin or other blood/plasma products.\n* Experienced anaphylactic shock with the administration of blood/plasma products.\n* Known medical history of selective immunoglobulin A (IgA) deficiency.\n* Received any corticosteroids, immunosuppressants, or immunomodulators within 6 weeks prior to screening.\n* 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.\n* Currently receiving any anti-viral treatment.\n* 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).\n* 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.\n* Not willing to postpone receiving any live virus vaccines until 3 months after receiving investigational product.\n* History of a psychiatric illness requiring hospitalization.\n* Known substance or prescription drug abuse in the past 12 months.\n* Any active medical illness that the Investigator may consider a potential confounding condition that would interfere with the study visits and/or procedures.'}, 'identificationModule': {'nctId': 'NCT02139657', 'briefTitle': 'An Open-label, Single-Arm Study to Evaluate the Safety and Rabies Virus Antibody Titers of Intramuscularly Administered Rabies Immune Globulin (Human)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Grifols Therapeutics LLC'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'GTI1301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RIG-C', 'description': 'Single 20 IU/kg dose of RIG-C by intramuscular injection', 'interventionNames': ['Biological: RIG-C']}], 'interventions': [{'name': 'RIG-C', 'type': 'BIOLOGICAL', 'otherNames': ['Rabies Immune Globulin (Human), Caprylate/Chromatography Purified'], 'armGroupLabels': ['RIG-C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85283', 'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Grifols Therapeutics LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}