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NCT00453999 · ClinicalTrials.gov registry record · Phase 2

Evaluation of Efficacy and Safety of Peramivir in Adults With Acute Serious or Potentially Life-threatening Influenza

A Phase 2 study, sponsored by BioCryst Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
137
Enrollment target

NCT00453999: Completed Phase 2 study, sponsored by BioCryst Pharmaceuticals.

NCT00453999 is a Phase 2 study that has completed, run by BioCryst Pharmaceuticals. The registered enrollment target is 137 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00453999, a Phase 2 study, has completed, sponsored by BioCryst Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
137 participants
Enrollment target

Study Summary

This study has been designed as a randomized, double-blind, controlled, study to evaluate the efficacy and safety of two once daily intravenous peramivir regimens (200 mg and 400 mg) versus oral oseltamivir phosphate (75 mg twice daily) in hospitalized subjects with acute serious or potentially life threatening influenza. Study treatments will be provided for up to 5 consecutive days.

Primary Outcome

Time to clinical stability was summarized overall and for individual clinical signs for each treatment group using the method of Kaplan Meier. Subjects who did not experience clinical stability were censored at the date of their last non-missing assessment during the study (whether this assessment occurred as an inpatient or as an outpatient).

Interventions

  • DRUG Oseltamivir
  • DRUG Peramivir 200 mg
  • DRUG Peramivir 400 mg

Trial Details

FieldValue
Enrollment Target 137 participants
Start Date 2007-07
Est. Completion 2009-08
Phase Phase 2
BioCryst Pharmaceuticals

29 total trials

What the finished NCT00453999 record still lists

NCT00453999 is an interventional study that assigns participants to a tested intervention. The registered 137 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.

The record links to 0 conditions, and to 3 interventions - of which Oseltamivir is the first listed.

NCT00453999 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00453999 about?

NCT00453999 is a clinical study titled "Evaluation of Efficacy and Safety of Peramivir in Adults With Acute Serious or Potentially Life-threatening Influenza". This study has been designed as a randomized, double-blind, controlled, study to evaluate the efficacy and safety of two once daily intravenous peramivir regimens (200 mg and 400 mg) versus oral oseltamivir phosphate (75 mg twice daily) in hospitalized subjects with acute serious or potentially life...

What is the current status of trial NCT00453999?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 137 participants. The study started on 2007-07. Estimated completion is 2009-08.

What interventions are being tested in trial NCT00453999?

The interventions under investigation include: Oseltamivir (DRUG), Peramivir 200 mg (DRUG), Peramivir 400 mg (DRUG).

Who is sponsoring clinical trial NCT00453999?

This trial is sponsored by BioCryst Pharmaceuticals, which has 29 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00453999's enrollment target sits among peer trials

137 527th of 2000 higher than 1,474 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT00453999, the US trial registry maintained by the National Library of Medicine. NCT00453999 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.