Clinical trial NCT01096576: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Dengue
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2010-03-31
Enrollment: 64
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Safety and tolerability: Adverse events, laboratory parameters, vital signs
timeFrame: days 1-7 and on follow-up days 14, 28 and 84
Secondary outcomes:
measure: Viral load
timeFrame: days 1-7 and 14
measure: Pharmacokinetics: plasma concentrations of RO1042897, balapiravir and metabolites
timeFrame: multiple sampling days 1 and 5
measure: Body temperature
timeFrame: days 1-7 and on follow-up days 14, 28 and 84
measure: Immunological parameters: plasma samples (cytokines)
timeFrame: days 1-7 and 14
measure: Hematological parameters: blood samples (red and white blood cell count, hemoglobin, hematocrit, reticulocyte count, fibrinogen, platelet count)
timeFrame: days 1-7, and on follow-up days 14, 28 and 84
measure: Quality of life
timeFrame: assessments days 1, 3, 5, 7, 14, 28 and 84
Other outcomes:
Locations:
city: Ho Chi Minh City
country: Vietnam
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.