A Study of Balapiravir in Patients With Dengue Virus Infection

Dengue Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01096576
• Other study ID #: PP22799
• Status: Completed
• Phase: Phase 1
• First received: March 17, 2010
• Last updated: November 1, 2016
• Start date: July 2010
• Est. completion date: April 2011

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dengue
• Virus Diseases

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability: Adverse events, laboratory parameters, vital signs		days 1-7 and on follow-up days 14, 28 and 84	No
Secondary	Viral load		days 1-7 and 14	No
Secondary	Pharmacokinetics: plasma concentrations of RO1042897, balapiravir and metabolites		multiple sampling days 1 and 5	No
Secondary	Body temperature		days 1-7 and on follow-up days 14, 28 and 84	No
Secondary	Immunological parameters: plasma samples (cytokines)		days 1-7 and 14	No
Secondary	Hematological parameters: blood samples (red and white blood cell count, hemoglobin, hematocrit, reticulocyte count, fibrinogen, platelet count)		days 1-7, and on follow-up days 14, 28 and 84	No
Secondary	Quality of life		assessments days 1, 3, 5, 7, 14, 28 and 84	No