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Safety Study of Single Administration Post-Exposure Prophylaxis Treatment for Ebola Virus

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ClinicalTrials.gov Identifier: NCT01353027
Recruitment Status : Completed
First Posted : May 12, 2011
Last Update Posted : March 28, 2012
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Sarepta Therapeutics, Inc.

Study Description
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Brief Summary:
The purpose of this study is to characterize the safety and pharmacology of single administrations of AVI-6002, a post-exposure prophylaxis candidate treatment for Ebolavirus.

Condition or disease Intervention/treatment Phase
Ebola Hemorrhagic Fever Drug: Placebo Drug: AVI-6002 Phase 1

Detailed Description:

Ebola hemorrhagic fever (EHF) is a rare human disease caused by Ebola Virus (EBOV), a filamentous single-stranded, negative-sense RNA virus. Since 1976 several Ebolavirus outbreaks have occurred with fatality rates ranging from 57% to 90%, with most of these outbreaks traced to single EBOV species; EBOV-Z. No effective therapy is currently available for Ebolavirus.

AVI-6002 is an experimental combination of 2 phosphorodiamidate morpholino antisense oligomers with positive charges on selected subunits (PMOplus™). These oligomers specifically target viral messenger RNA encoding 2 Ebolavirus proteins thought to be important in viral replication and host immune suppression. The present study is designed to characterize the safety, tolerability and pharmacokinetics of escalating single-administration doses of AVI-6002 in healthy human subjects.


Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase I Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Dose-Escalation Study to Assess the Safety, Tolerability and Pharmacokinetics of AVI-6002 in Healthy Adult Volunteers
Study Start Date : May 2010
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ebola

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
Normal saline
Experimental: AVI-6002
Phosphorodiamidate morpholino antisense oligomer with positive charges on selected subunits (PMOplus™)
 Drug: AVI-6002
Single intravenous administration


Outcome Measures
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Primary Outcome Measures :
  1. Number of participants with adverse events [ Time Frame: 28 Days ]
    The frequency and severity of adverse events will be monitored through 28 days post administration.


Secondary Outcome Measures :
  1. Drug concentration in plasma [ Time Frame: 28 days ]
  2. Drug concentration in urine [ Time Frame: 28 days ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Male or female and between the ages of 18 and 50 years in good general health
  • Volunteers must be willing to use barrier methods of contraception or be of non-childbearing potential
  • Volunteers must be willing to undergo a urine screen for drugs of abuse

Exclusion Criteria:

  • Pregnancy or breastfeeding.
  • Any clinically relevant abnormalities in physical examinations, vital signs, ECG, clinical chemistry, hematology or urinalysis
  • Positive test for human immunodeficiency virus, hepatitis B or hepatitis C or known history of HIV infection
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): NCT01353027


Locations
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United States, Tennessee
New Orleans Center for Clinical Research - Knoxville
Knoxville, Tennessee, United States, 37920
Sponsors and Collaborators
Sarepta Therapeutics, Inc.
United States Department of Defense
Investigators
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Principal Investigator: William B Smith, MD New Orleans Center for Clinical Research-Knoxville
Study Director: Alison Heald, MD Sarepta Therapeutics, Inc.
More Information
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Responsible Party: Sarepta Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT01353027     History of Changes
Other Study ID Numbers: 6002-us-101
First Posted: May 12, 2011    Key Record Dates
Last Update Posted: March 28, 2012
Last Verified: March 2012

Additional relevant MeSH terms:
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Hemorrhagic Fevers, Viral
Hemorrhagic Fever, Ebola
RNA Virus Infections
 Virus Diseases
Filoviridae Infections
Mononegavirales Infections