A Study of Balapiravir in Patients With Dengue Virus Infection

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

Tracking Information

• First Submitted Date: March 17, 2010
• First Posted Date: March 31, 2010
• Last Update Posted Date: November 2, 2016
• Study Start Date: July 2010
• Actual Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of Balapiravir in Patients With Dengue Virus Infection
• 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
• 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: Interventional
• Study Phase: Phase 1
• Study Design: Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Dengue

Intervention

• Drug: balapiravir [RO4588161]
  sequential cohorts receiving doses orally twice daily for 5 days
• Drug: placebo
  orally twice daily for 5 days

Study Arms

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 7, 2012): 64
• Original Estimated Enrollment (submitted: March 30, 2010): 100
• Actual Study Completion Date: April 2011
• Actual Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Vietnam

Administrative Information

• NCT Number: NCT01096576
• Other Study ID Numbers: PP22799
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Hoffmann-La Roche
• Original Responsible Party: Disclosures Group, Hoffmann-La Roche
• Current Study Sponsor: Hoffmann-La Roche
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Clinical Trials; Hoffmann-La Roche

• PRS Account: Hoffmann-La Roche
• Verification Date: November 2016