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

Tracking Information
First Submitted Date  ICMJE March 17, 2010
First Posted Date  ICMJE March 31, 2010
Last Update Posted Date November 2, 2016
Study Start Date  ICMJE July 2010
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 30, 2010)
Safety and tolerability: Adverse events, laboratory parameters, vital signs [ Time Frame: days 1-7 and on follow-up days 14, 28 and 84 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 30, 2010)
  • Viral load [ Time Frame: days 1-7 and 14 ]
  • Pharmacokinetics: plasma concentrations of RO1042897, balapiravir and metabolites [ Time Frame: multiple sampling days 1 and 5 ]
  • Body temperature [ Time Frame: days 1-7 and on follow-up days 14, 28 and 84 ]
  • Immunological parameters: plasma samples (cytokines) [ Time Frame: days 1-7 and 14 ]
  • 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 ]
  • Quality of life [ Time Frame: assessments days 1, 3, 5, 7, 14, 28 and 84 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE A Study of Balapiravir in Patients With Dengue Virus Infection
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Dengue
Intervention  ICMJE
  • Drug: balapiravir [RO4588161]
    sequential cohorts receiving doses orally twice daily for 5 days
  • Drug: placebo
    orally twice daily for 5 days
Study Arms  ICMJE
  • Experimental: A
    Intervention: Drug: balapiravir [RO4588161]
  • Placebo Comparator: B
    Intervention: Drug: placebo
Publications * Nguyen NM, Tran CN, Phung LK, Duong KT, Huynh Hle A, Farrar J, Nguyen QT, Tran HT, Nguyen CV, Merson L, Hoang LT, Hibberd ML, Aw PP, Wilm A, Nagarajan N, Nguyen DT, Pham MP, Nguyen TT, Javanbakht H, Klumpp K, Hammond J, Petric R, Wolbers M, Nguyen CT, Simmons CP. A randomized, double-blind placebo controlled trial of balapiravir, a polymerase inhibitor, in adult dengue patients. J Infect Dis. 2013 May 1;207(9):1442-50. doi: 10.1093/infdis/jis470. Epub 2012 Jul 17.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 7, 2012)
Original Estimated Enrollment  ICMJE
 (submitted: March 30, 2010)
Actual Study Completion Date  ICMJE April 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Vietnam
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01096576
Other Study ID Numbers  ICMJE PP22799
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Hoffmann-La Roche
Original Responsible Party Disclosures Group, Hoffmann-La Roche
Current Study Sponsor  ICMJE Hoffmann-La Roche
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP