Oral Triple Combination Antiviral Drug Therapy for Treatment of Influenza A in Immunocompromised Subjects

NCT ID: NCT00979251

Last Updated: 2014-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2011-08-31

Brief Summary

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This Phase 2, open label, randomized study will investigate the virologic benefit, clinical efficacy, safety, and tolerability of amantadine and ribavirin with oseltamivir (TCAD) versus oseltamivir monotherapy for the treatment of all strains of influenza A in immunocompromised adult and pediatric subjects.

Detailed Description

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Conditions

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Influenza

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ADS-8902

Amantadine and Ribavirin administered with Oseltamivir phosphate

Group Type EXPERIMENTAL

ADS-8902

Intervention Type DRUG

Amantadine Hydrochloride, Ribavirin administered with Oseltamivir Phosphate, q8h

Comparator

Oseltamivir Phosphate

Group Type ACTIVE_COMPARATOR

Oseltamivir Phosphate

Intervention Type DRUG

Oseltamivir Phosphate, q8h

Interventions

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Oseltamivir Phosphate

Oseltamivir Phosphate, q8h

Intervention Type DRUG

ADS-8902

Amantadine Hydrochloride, Ribavirin administered with Oseltamivir Phosphate, q8h

Intervention Type DRUG

Other Intervention Names

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Tamiflu Amantadine Hydrochloride RebetolĀ® TamifluĀ®

Eligibility Criteria

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Inclusion Criteria

* Confirmed influenza A by rapid antigen testing
* Immunocompromised as defined by recent solid organ or hematopoietic transplant, chronic graft vs. host disease, taking at least 2 immunosuppressants, undergoing chemotherapy, taking high dose chemotherapeutics, HIV positive
* Clinical diagnosis of influenza
* Onset of illness within 5 days
* Male and female subjects agree to contraception through 24 weeks after last dose

Exclusion Criteria

* Received more than 1 dose of antiviral agents
* Critically ill
* Creatinine clearance less than 80 mg/mL
* Females who are pregnant and males whose female partners are pregnant
* Received live attenuated virus vaccine within 3 weeks
Minimum Eligible Age

1 Year

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Adamas Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Adamas Investigational Site

San Francisco, California, United States

Site Status

Adamas Investigational Site

San Francisco, California, United States

Site Status

Adamas Investigational Site

San Francisco, California, United States

Site Status

Adamas Investigational Site

Hollywood, Florida, United States

Site Status

Adamas Investigational Site

Miramar, Florida, United States

Site Status

Adamas Investigational Site

Pinellas Park, Florida, United States

Site Status

Adamas Investigational Site

Honolulu, Hawaii, United States

Site Status

Adamas Investigational Site

Owensboro, Kentucky, United States

Site Status

Adamas Investigational Site

New Orleans, Louisiana, United States

Site Status

Adamas Investigational Site

Las Vegas, Nevada, United States

Site Status

Adamas Investigational Site

New York, New York, United States

Site Status

Adamas Investigational Site

Rapid City, South Dakota, United States

Site Status

Adamas Investigational Site

Memphis, Tennessee, United States

Site Status

Adamas Investigational Site

Amarillo, Texas, United States

Site Status

Adamas Investigational Site

Seattle, Washington, United States

Site Status

Adamas Investigational Site

Tacoma, Washington, United States

Site Status

Adamas Investigational Site

Darlinghurst, New South Wales, Australia

Site Status

Adamas Investigational Site

Herston, New South Wales, Australia

Site Status

Adamas Investigational Site

Sydney, New South Wales, Australia

Site Status

Adamas Investigative Site

Parkville, Victoria, Australia

Site Status

Adamas Investigational Site

Melbourne, , Australia

Site Status

Adamas Investigational Site

Edmonton, Alberta, Canada

Site Status

Adamas Investigational Site

Toronto, Ontario, Canada

Site Status

Adamas Investigational Site

Leiden, , Netherlands

Site Status

Adamas Investigational Site

Singapore, , Singapore

Site Status

Countries

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United States Australia Canada Netherlands Singapore

Other Identifiers

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ADS-TCAD-PO206

Identifier Type: -

Identifier Source: org_study_id

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