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Interferon-alpha

Phase 2

Influenza A Virus Infection | Small molecule | Infectious Disease |Ainos, Inc.|Last Updated: Aug 21, 2013

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

Interferon-alpha · 3 trials · 4 indications

Phase 2 3
NCT01146535Interferon Alpha Lozenges Plus Oseltamivir for Influenza TreatmentInfluenza A Virus Infection
COMPLETED40 Analytics
NCT00895947Interferon Alpha Lozenges in the Prevention of Winter Colds and FluUpper Respiratory Tract Infections
COMPLETED200 Analytics
NCT00454181Treatment of Oral Warts in HIV+ PatientsPapillomatosis
COMPLETED59 Analytics
PHASE2COMPLETED
Interferon Alpha Lozenges Plus Oseltamivir for Influenza Treatment
Influenza A Virus InfectionUnlock trial analytics
PHASE2COMPLETED
Interferon Alpha Lozenges in the Prevention of Winter Colds and Flu
Upper Respiratory Tract InfectionsUnlock trial analytics
PHASE2COMPLETED
Treatment of Oral Warts in HIV+ Patients
PapillomatosisUnlock trial analytics

Study Endpoints

Primary Endpoints

Resolution of fever and flu symptoms
Days 1-5

Time to resolution of influenza symptoms defined as all flu symptoms scored as \<=1 and change in viral load (RT-PCR).

Frequency of Influenza-like Illness
16 weeks

Number of subjects in each group meeting the definition of influenza-like illness during treatment (i.e. those subject reporting one or more moderate to severe cold/flu symptoms during the treatment period).

Change in Total Oral Mucosal Area Covered by Warts.
24 weeks, from baseline to the end of treatment

Number of subjects with a 75% or greater decrease from baseline to week 24 in total oral wart area

Secondary Endpoints

Clinical response
Day 3 and Day 6
Proportion of poor responders
Day 3 and Day 6
Time to resolution of fever
Days 1-5
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Interferon-alphaEXPERIMENTALInterferon-alpha 150 IU lozenges bid for 5 days
maltosePLACEBO_COMPARATORmaltose 200 mg maltose lozenges bid for 5 days
placeboPLACEBO_COMPARATORplacebo lozenges
IFN lozengesEXPERIMENTAL500 IU Interferon-alpha lozenges for oral dissolution
placebo lozengesPLACEBO_COMPARATOR200 mg lozenges containing anhydrous crystalline maltose

Interventions

NameTypeDescription
Interferon-alphaDRUG150 IU lozenges bid for 5 days
OseltamivirDRUG75 mg capsules bid for 5 days
maltoseOTHER200 mg maltose lozenges bid for 5 days
placeboOTHERplacebo lozenges for oral dissolution taken once daily for 16 weeks
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Eligibility Criteria

Age Range20 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: * fever \>=38C * one or more respiratory symptoms (e.g. cough, rhinorrhea or sore throat) plus one or more constitutional symptoms (e.g. chills, headache, malaise and myalgias)of \< 48 hours' duration * body weight \> 40 kg * positive for influenza A (nasal swab rapid test) Exc...

Countries:TaiwanAustraliaUnited States
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Frequently asked questions about Interferon-alpha

What is Interferon-alpha used for?

Interferon-alpha is an investigational small molecule being studied for upper respiratory tract infections, papillomatosis, and influenza A virus infection. It is delivered as lozenges in clinical trials. The drug is not approved and remains in clinical development.

Who makes Interferon-alpha?

Interferon-alpha is being developed by Ainos, Inc. (NASDAQ: AIMD). The company is conducting clinical trials of the drug for infectious disease indications.

What phase is Interferon-alpha in?

Interferon-alpha is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. All three completed trials were Phase 2 studies.

What clinical trials has Interferon-alpha been in?

Interferon-alpha has been studied in three completed Phase 2 trials: NCT00454181 for oral warts in HIV patients, NCT00895947 for prevention of winter colds and flu, and NCT01146535 for influenza treatment with oseltamivir.

How does Interferon-alpha work?

Interferon-alpha is a small molecule that works by mimicking the body's natural interferon-alpha protein, which helps regulate immune responses against viral infections. It is being studied as lozenges for respiratory and viral conditions.

Is Interferon-alpha the same as other interferons?

Interferon-alpha is a specific type of interferon, distinct from interferon-beta and interferon-gamma. It is being developed by Ainos, Inc. as a lozenge formulation for infectious disease indications.