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Completed Phase 1 Interventional Results available

Pharmacokinetic Study of ADVATE Reconstituted in 2 mL Sterile Water for Injection

ClinicalTrials.gov ID: NCT00952822

Public ClinicalTrials.gov record NCT00952822. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 2, 2026, 8:01 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 1, Prospective, Randomized, Crossover Study to Compare the Pharmacokinetics and Safety of rAHF-PFM Reconstituted in 2 mL Versus 5 mL SWFI in Previously Treated Severe Hemophilia A Patients

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The purpose of this study is to determine the pharmacokinetics and safety of Antihemophilic factor, recombinant, manufactured protein-free (rAHF-PFM) reconstituted in 2 mL sterile water for injection (SWFI) and compare with those of rAHF-PFM reconstituted in 5 mL of SWFI.

Study identification

NCT ID
NCT00952822
Recruitment status
Completed
Study type
Interventional
Phase
Phase 1
Lead sponsor
Baxalta now part of Shire
Industry
Enrollment
52 participants

Conditions and interventions

Eligibility (public fields only)

Age range
2 Years to 65 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Aug 7, 2008
Primary completion
Oct 22, 2009
Completion
Oct 22, 2009
Last update posted
May 23, 2021

2008 – 2009

United States locations

U.S. sites
11
U.S. states
10
U.S. cities
11
Facility City State ZIP Site status
Not listed Washington D.C. District of Columbia
Not listed Atlanta Georgia
Not listed Lexington Kentucky
Not listed Louisville Kentucky
Not listed Detroit Michigan
Not listed New Brunswick New Jersey
Not listed New York New York
Not listed Cincinnati Ohio
Not listed Portland Oregon
Not listed Philadelphia Pennsylvania
Not listed Houston Texas

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00952822, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 23, 2021 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00952822 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →