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

Phase 2

Completed

• Conditions: Influenza
• Interventions: Drug: ADS-8902; Drug: Oseltamivir Phosphate

• Registration Number: NCT00979251
• Lead Sponsor: Adamas Pharmaceuticals, Inc.

Brief Summary

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

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-16
• Study First Submitted QC: 2009-09-16
• Study First Posted: 2009-09-17
• Primary Completion: 2010-05
• Study Completion: 2011-08
• Disposition First Submitted: 2014-02-14
• Status Verified: 2014-03
• Disposition First Submitted QC: 2014-03-17
• Last Update Submitted: 2014-03-17
• Disposition First Posted: 2014-04-14
• Last Update Posted: 2014-04-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ADS-8902	ADS-8902	Amantadine and Ribavirin administered with Oseltamivir phosphate
Comparator	Oseltamivir Phosphate	Oseltamivir Phosphate

Primary Outcome Measures

Name	Time	Method
Time to clearing of viral shedding	Baseline, Days 2, 4, 6, 8, 10, 15 and 20

Secondary Outcome Measures

Name	Time	Method
Time to alleviation of influenza clinical symptoms	Baseline, Days 2, 4, 6, 8, 10, 15, 20, 38
Proportion of subjects who enter the study with mild to moderate influenza and progress to severe influenza	Baseline, Days 2, 4, 6, 8, 10, 15, 20, 38
Proportion of subjects with a treatment-sensitive influenza A strain at baseline who develop a resistant strain during treatment	Baseline, Days 2, 4, 6, 8, 10, 15, 20
Safety and tolerability (adverse events (AEs), AEs resulting in treatment discontinuation, and Serious AEs)	Through day 210

Trial Locations

Locations (2)

Adamas Investigational Site; 🇸🇬 Singapore, Singapore

Adamas Investigative Site; 🇦🇺 Parkville, Victoria, Australia