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balapiravir

Phase 1

Dengue | Small molecule | Infectious Disease |Roche Holding AG|Last Updated: Nov 2, 2016

Success Probability

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Market & Valuation

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Trial Design

Double-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment64

FDA Designations

No designations recorded

Clinical trial landscape

balapiravir · 1 trial · 1 indication

Phase 1 1
NCT01096576A Study of Balapiravir in Patients With Dengue Virus InfectionDengue
COMPLETED64 Analytics
PHASE1COMPLETED
A Study of Balapiravir in Patients With Dengue Virus Infection
DengueUnlock trial analytics

Study Endpoints

Primary Endpoints

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

Secondary Endpoints

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
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Study Design & Arms

MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
AEXPERIMENTAL -
BPLACEBO_COMPARATOR -

Interventions

NameTypeDescription
balapiravir [RO4588161]DRUGsequential cohorts receiving doses orally twice daily for 5 days
placeboDRUGorally twice daily for 5 days
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Eligibility Criteria

Age Range18 Years to 65 Years
SexMALE
Healthy VolunteersNo
Study Sites1

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 receiv...

Countries:Vietnam
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Frequently asked questions about balapiravir

What is balapiravir used for?

Balapiravir is an investigational small molecule being studied for the treatment of dengue virus infection. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities. The drug is being evaluated in patients with dengue, a mosquito-borne viral illness.

Who makes balapiravir?

Balapiravir is being developed by Roche Holding AG, a multinational pharmaceutical company. Roche's stock is traded under the ticker symbol RHHBY on the OTC market. The company is conducting clinical research on this investigational drug for dengue virus infection.

What phase is balapiravir in?

Balapiravir is in Phase 1 clinical development. It is an investigational drug and has not received regulatory approval. A Phase 1 study of balapiravir in patients with dengue virus infection has been completed, but the drug remains in early-stage clinical testing.

What clinical trials is balapiravir in?

Balapiravir has one completed clinical trial registered as NCT01096576, titled 'A Study of Balapiravir in Patients With Dengue Virus Infection.' This Phase 1 study enrolled 64 male participants aged 18 years and older in Vietnam. The trial was placebo-controlled and double-blind, but was not randomized.

Is balapiravir the same as any other drug?

Balapiravir is not known to have alternative names. It is a distinct investigational small molecule being developed by Roche for dengue virus infection. No other names for this drug have been reported in clinical trial registrations.