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A Study of Oseltamivir (Tamiflu) for the Seasonal Prophylaxis of Influenza in Immunocompromised Participants

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Roche

Status and phase

Completed
Phase 4

Conditions

Influenza

Treatments

Drug: Oseltamivir
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00412737
NV20235

Details and patient eligibility

About

This 2 arm study will evaluate the efficacy and safety of oseltamivir in the seasonal prophylaxis of influenza in immunocompromised participants (as represented by transplant recipients). Transplant recipients enrolled when influenza is circulating in the community will be randomized to receive oseltamivir syrup or capsules 30 milligrams (mg) to 75 mg daily (depending on body weight) or placebo for 12 weeks. Influenza symptoms and safety data will be recorded throughout the study.

Enrollment

477 patients

Sex

All

Ages

1+ year old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Negative rapid diagnostic test for influenza at baseline;
  • Immunocompromised participant (liver and/or kidney recipient or allogenic hematopoietic stem cell transplant).

Exclusion criteria

  • Symptoms suggestive of influenza-like illness; but not limited to fever, cough, or nasal congestion;
  • Influenza vaccination in 6 weeks prior to randomization;
  • Positive rapid diagnostic test for influenza;
  • Solid organ transplant within 6 months of randomization;
  • Antiviral treatment for influenza in 2 weeks prior to randomization.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

477 participants in 2 patient groups, including a placebo group

Oseltamivir
Experimental group
Treatment:
Drug: Oseltamivir
Placebo
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

78

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Data sourced from clinicaltrials.gov

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