NCT01096576

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2010

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 31, 2010

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

November 2, 2016

Status Verified

November 1, 2016

Enrollment Period

9 months

First QC Date

March 17, 2010

Last Update Submit

November 1, 2016

Conditions

Dengue

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability: Adverse events, laboratory parameters, vital signs

    days 1-7 and on follow-up days 14, 28 and 84

Secondary Outcomes (6)

  • Viral load

    days 1-7 and 14

  • Pharmacokinetics: plasma concentrations of RO1042897, balapiravir and metabolites

    multiple sampling days 1 and 5

  • Body temperature

    days 1-7 and on follow-up days 14, 28 and 84

  • Immunological parameters: plasma samples (cytokines)

    days 1-7 and 14

  • 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

  • +1 more secondary outcomes

Study Arms (2)

A

EXPERIMENTAL
Drug: balapiravir [RO4588161]

B

PLACEBO COMPARATOR
Drug: placebo

Interventions

balapiravir [RO4588161]DRUG

sequential cohorts receiving doses orally twice daily for 5 days

A
placeboDRUG

orally twice daily for 5 days

B

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Ho Chi Minh City, District 5, Vietnam

Location

Related Publications (1)

  • 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.

    PMID: 22807519DERIVED

MeSH Terms

Conditions

Dengue

Interventions

balapiravir

Condition Hierarchy (Ancestors)

Mosquito-Borne DiseasesVector Borne DiseasesInfectionsArbovirus InfectionsVirus DiseasesFlavivirus InfectionsFlaviviridae InfectionsRNA Virus InfectionsHemorrhagic Fevers, Viral

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2010

First Posted

March 31, 2010

Study Start

July 1, 2010

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

November 2, 2016

Record last verified: 2016-11

Locations

VN(1)