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NCT00412737 · ClinicalTrials.gov registry record · Phase 4

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

A Phase 4 study, sponsored by Hoffmann-La Roche.

Completed
Registry status
Phase 4
Development phase
477
Enrollment target

NCT00412737: Completed Phase 4 study, sponsored by Hoffmann-La Roche.

NCT00412737 is a Phase 4 study that has completed, run by Hoffmann-La Roche. The registered enrollment target is 477 participants, roughly in line with the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00412737, a Phase 4 study, has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
Phase 4
Development phase
477 participants
Enrollment target

Study Summary

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.

Primary Outcome

Laboratory-confirmed clinical influenza was defined as a fever (oral or otic temperature greater than \[\>\] 37.2 degrees Celsius \[°C\]) and a symptom score for cough and/or coryza (nasal congestion on the diary cards, where 0=absent, 1=mild, 2=moderate, and 3=severe) of 1, 2 or 3 on the same day as fever, and laboratory confirmation of influenza either by detection of viral shedding by viral culture from nasopharyngeal swabs within two days of fever and symptoms, and/or by 4-fold or greater in

Interventions

  • DRUG Placebo
  • DRUG Oseltamivir

Trial Details

FieldValue
Enrollment Target 477 participants
Start Date 2007-01
Est. Completion 2008-05
Phase Phase 4
Hoffmann-La Roche

909 total trials

What the finished NCT00412737 record still lists

NCT00412737 is an interventional study that assigns participants to a tested intervention. The registered 477 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT00412737 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00412737 about?

NCT00412737 is a clinical study titled "A Study of Oseltamivir (Tamiflu) for the Seasonal Prophylaxis of Influenza in Immunocompromised Participants". 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 osel...

What is the current status of trial NCT00412737?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 477 participants. The study started on 2007-01. Estimated completion is 2008-05.

What interventions are being tested in trial NCT00412737?

The interventions under investigation include: Placebo (DRUG), Oseltamivir (DRUG).

Who is sponsoring clinical trial NCT00412737?

This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00412737's enrollment target sits among peer trials

477 182nd of 2000 higher than 1,819 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00412737, the US trial registry maintained by the National Library of Medicine. NCT00412737 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.