A Study of Balapiravir in Patients With Dengue Virus Infection

Roche

Status and phase: Completed; Phase 1

Conditions: Dengue

Treatments: Drug: placebo; Drug: balapiravir [RO4588161]

Study type: Interventional

Funder types: Industry

Identifiers

NCT01096576

PP22799

Details and patient eligibility

About

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

Enrollment: 64 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

64 participants in 2 patient groups, including a placebo group

A

Experimental group

Treatment:

Drug: balapiravir [RO4588161]

B

Placebo Comparator group

Treatment:

Drug: placebo