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A Study of Balapiravir in Patients With Dengue Virus Infection

Primary Purpose

Dengue

Status

Completed

Phase

Phase 1

Locations

Vietnam

Study Type

Interventional

Intervention

balapiravir [RO4588161]

placebo

About this trial

This is an interventional treatment trial for Dengue

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Viral load

Pharmacokinetics: plasma concentrations of RO1042897, balapiravir and metabolites

Body temperature

Immunological parameters: plasma samples (cytokines)

Hematological parameters: blood samples (red and white blood cell count, hemoglobin, hematocrit, reticulocyte count, fibrinogen, platelet count)

Quality of life

Full Information

NCT ID

NCT01096576

First Posted

March 17, 2010

Last Updated

November 1, 2016

Sponsor

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT01096576

Brief Title

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

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Completed

Study Start Date

July 2010 (undefined)

Primary Completion Date

April 2011 (Actual)

Study Completion Date

April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hoffmann-La Roche

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dengue

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Enrollment

64 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

balapiravir [RO4588161]

Intervention Description

sequential cohorts receiving doses orally twice daily for 5 days

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

orally twice daily for 5 days

Primary Outcome Measure Information:

Title

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

Time Frame

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

Secondary Outcome Measure Information:

Title

Viral load

Time Frame

days 1-7 and 14

Title

Pharmacokinetics: plasma concentrations of RO1042897, balapiravir and metabolites

Time Frame

multiple sampling days 1 and 5

Title

Body temperature

Time Frame

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

Title

Immunological parameters: plasma samples (cytokines)

Time Frame

days 1-7 and 14

Title

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

Title

Quality of life

Time Frame

assessments days 1, 3, 5, 7, 14, 28 and 84

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trials

Organizational Affiliation

Hoffmann-La Roche

Official's Role

Study Director

Facility Information:

City

Ho Chi Minh City

ZIP/Postal Code

District 5

Country

Vietnam

12. IPD Sharing Statement

Citations:

PubMed Identifier

22807519

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.

Results Reference

derived

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A Study of Balapiravir in Patients With Dengue Virus Infection

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