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A Study of Balapiravir in Patients With Dengue Virus Infection

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01096576
First received: March 17, 2010
Last updated: September 7, 2012
Last verified: September 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Dengue
 Drug: balapiravir [RO4588161]
Drug: placebo
 Phase 1

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

Resource links provided by NLM:

MedlinePlus related topics: Dengue
U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Safety and tolerability: Adverse events, laboratory parameters, vital signs [ Time Frame: days 1-7 and on follow-up days 14, 28 and 84 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Viral load [ Time Frame: days 1-7 and 14 ] [ Designated as safety issue: No ]
  • Pharmacokinetics: plasma concentrations of RO1042897, balapiravir and metabolites [ Time Frame: multiple sampling days 1 and 5 ] [ Designated as safety issue: No ]
  • Body temperature [ Time Frame: days 1-7 and on follow-up days 14, 28 and 84 ] [ Designated as safety issue: No ]
  • Immunological parameters: plasma samples (cytokines) [ Time Frame: days 1-7 and 14 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: assessments days 1, 3, 5, 7, 14, 28 and 84 ] [ Designated as safety issue: No ]

Enrollment: 64
Study Start Date: July 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01096576

Locations
Vietnam
Ho Chi Minh City, Vietnam, District 5
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01096576     History of Changes
Other Study ID Numbers: PP22799
Study First Received: March 17, 2010
Last Updated: September 7, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Dengue
Virus Diseases
Arbovirus Infections
Flavivirus Infections
 Flaviviridae Infections
RNA Virus Infections
Hemorrhagic Fevers, Viral

ClinicalTrials.gov processed this record on May 22, 2013