A Study of Oseltamivir (Tamiflu) for Treatment of Influenza in Immunocompromised Participants.

Roche

Status and phase: Completed; Phase 3

Conditions: Influenza, Human

Treatments: Drug: oseltamivir; Other: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00545532

NV20234

2006-002468-24 (EudraCT Number)

Details and patient eligibility

About

This 2-arm study will investigate the safety and tolerability of oseltamivir for the treatment of influenza in immunocompromised participants and characterize the effects of oseltamivir in immunocompromised participants on the development of resistant influenza virus. Eligible immunocompromised participants with laboratory-confirmed influenza will be randomized to receive either conventional dose (30 milligrams [mg] to 75 mg twice daily orally [po], depending on age and weight) or double dose (60 mg-150 mg twice daily po depending on age and weight) olseltamivir for 10 days. Nasal and throat swabs will be taken, and safety evaluations made, at intervals during the study. The anticipated time on study medication is 10 days and the anticipated time on study is 40 days.

Enrollment: 228 patients

Sex: All

Ages: 1+ year old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Rapid diagnostic test, PCR, or viral culture positive for influenza in the 96 hours prior to first dose
• Immunocompromised participants with primary or secondary immunodeficiency
• Symptoms suggestive of influenza-like illness
• Use of an effective contraceptive, as specified by protocol; women of childbearing potential cannot be pregnant or breastfeeding

Exclusion criteria

• Influenza vaccination with live attenuated vaccine in the 2 weeks prior to randomization
• Antiviral treatment for influenza in 2 weeks prior to randomization
• Severe hepatic impairment
• Any current renal replacement therapy
• Any gastrointestinal disorders which may interfere with the absorption of oseltamivir
• Participation in a study with an investigational drug from 4 weeks prior to study start until study end

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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228 participants in 2 patient groups

Conventional dose

Experimental group

Description:

Immunocompromised participants will receive oseltamivir syrup at a dose ranging from 30 to 75 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 75 mg twice daily for adults/adolescents greater than or equal to (\>/=) 13 years old or placebo-matched to oseltamivir twice daily over 10 days.

Treatment:

Other: placebo

Drug: oseltamivir

Double dose

Experimental group

Description:

Immunocompromised participants will receive oseltamivir syrup at a dose ranging from 60 to 150 mg based on body weight, twice daily for children (1 to 12 years old) and oseltamivir capsules 150 mg twice daily for adults/adolescents (\>/=13 years old) or placebo matched to oseltamivir twice daily over 10 days.

Treatment:

Other: placebo

Drug: oseltamivir