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NCT Number: NCT01096576

A Study of Balapiravir in Patients With 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

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Key information

Conditions

Dengue Arbovirus Infections Flaviviridae Infections Flavivirus Infections Hemorrhagic Fevers, Viral Infections Mosquito-Borne Diseases RNA Virus Infections Vector Borne Diseases Virus Diseases

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Ho Chi Minh City, District 5, Vietnam

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

balapiravir [RO4588161]

Drug

sequential cohorts receiving doses orally twice daily for 5 days

Placebo

Drug

orally twice daily for 5 days

Primary outcomes

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

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

Secondary outcomes

  1. Viral load

    Time frame: days 1-7 and 14

  2. Pharmacokinetics: plasma concentrations of RO1042897, balapiravir and metabolites

    Time frame: multiple sampling days 1 and 5

  3. Body temperature

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

  4. Immunological parameters: plasma samples (cytokines)

    Time frame: days 1-7 and 14

  5. 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

  6. Quality of life

    Time frame: assessments days 1, 3, 5, 7, 14, 28 and 84

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 31, 2010
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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