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A Study of Balapiravir in Patients With Dengue Virus Infection

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: NCT01096576
Recruitment Status : Completed
First Posted : March 31, 2010
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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Brief Summary:
This randomized, double-blind, multiple-dose, placebo-controlled study will evaluate the safety, tolerability and efficacy of balapiravir in adult male patients with confirmed dengue virus infection whose symptoms began within the 48 hours preceding the first administration of balapiravir. Patients will be randomized to receive either balapiravir or placebo, orally twice daily for 5 days. Anticipated time on treatment as in-patient is 7 days, with an out-patient follow-up to week 12. Target sample size is <200

Condition or disease Intervention/treatment Phase
Dengue Drug: balapiravir [RO4588161] Drug: placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of the Dengue Virus Polymerase Inhibitor (Balapiravir) in Male Patients With Confirmed Dengue Virus Infection
Study Start Date : July 2010
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: A Drug: balapiravir [RO4588161]
sequential cohorts receiving doses orally twice daily for 5 days
Placebo Comparator: B Drug: placebo
orally twice daily for 5 days


Outcome Measures
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Primary Outcome Measures :
  1. Safety and tolerability: Adverse events, laboratory parameters, vital signs [ Time Frame: days 1-7 and on follow-up days 14, 28 and 84 ]

Secondary Outcome Measures :
  1. Viral load [ Time Frame: days 1-7 and 14 ]
  2. Pharmacokinetics: plasma concentrations of RO1042897, balapiravir and metabolites [ Time Frame: multiple sampling days 1 and 5 ]
  3. Body temperature [ Time Frame: days 1-7 and on follow-up days 14, 28 and 84 ]
  4. Immunological parameters: plasma samples (cytokines) [ Time Frame: days 1-7 and 14 ]
  5. Hematological parameters: blood samples (red and white blood cell count, hemoglobin, hematocrit, reticulocyte count, fibrinogen, platelet count) [ Time Frame: days 1-7, and on follow-up days 14, 28 and 84 ]
  6. Quality of life [ Time Frame: assessments days 1, 3, 5, 7, 14, 28 and 84 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • male patients, 18-65 years of age
  • dengue virus infection (confirmed by NS1 strip test) with symptom onset </=48 hours before first study drug administration
  • patients and their partners of childbearing potential must use 2 forms of contraception until 3 months after receiving the last dose of study drug
  • BMI between 18 and 35

Exclusion Criteria:

  • positive test at screening for HIV using point of care test, or known HIV infection
  • history of any disease known to cause significant alteration in immunologic function or autoimmune disease
  • patients taking steroid or other immuno-suppressive therapies
  • positive test for drugs of abuse or alcohol using point of care test
  • clinically significant abnormal laboratory test results which are deemed unassociated with dengue infection or, alternatively, are diagnostic of dengue shock syndrome
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): NCT01096576


Locations
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Vietnam
Ho Chi Minh City, Vietnam, District 5
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01096576    
Other Study ID Numbers: PP22799
First Posted: March 31, 2010    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Virus Diseases
Dengue
Infections
Arbovirus Infections
Vector Borne Diseases
 Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral