A Study of Balapiravir in Patients With Dengue Virus Infection

November 1, 2016 updated by: Hoffmann-La Roche

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
      • Ho Chi Minh City, Vietnam, District 5

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
Drug: balapiravir [RO4588161]
sequential cohorts receiving doses orally twice daily for 5 days
Placebo Comparator: B
Drug: placebo
orally twice daily for 5 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety and tolerability: Adverse events, laboratory parameters, vital signs
Time Frame: days 1-7 and on follow-up days 14, 28 and 84
days 1-7 and on follow-up days 14, 28 and 84

Secondary Outcome Measures

Outcome Measure
Time Frame
Viral load
Time Frame: days 1-7 and 14
days 1-7 and 14
Pharmacokinetics: plasma concentrations of RO1042897, balapiravir and metabolites
Time Frame: multiple sampling days 1 and 5
multiple sampling days 1 and 5
Body temperature
Time Frame: days 1-7 and on follow-up days 14, 28 and 84
days 1-7 and on follow-up days 14, 28 and 84
Immunological parameters: plasma samples (cytokines)
Time Frame: days 1-7 and 14
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
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
assessments days 1, 3, 5, 7, 14, 28 and 84

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

March 17, 2010

First Submitted That Met QC Criteria

March 30, 2010

First Posted (Estimate)

March 31, 2010

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PP22799

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Dengue

Clinical Trials on balapiravir [RO4588161]

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in United Kingdom

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe