Hemophilia ANCT00214734
ADVATE Post Authorization Safety Surveillance
An observational study of Hemophilia A, run by Baxalta now part of Shire at 37 sites in United States.
Trial summary
The primary objective of this post-authorization safety surveillance is to measure the incidence of adverse events that are at least possibly related to ADVATE use, in subjects receiving ADVATE in routine clinical practice. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Hemophilia A
- What is being tested?
- rAHF-PFM
- How many people
- 108 participants
- Where
- 37 sitesUnited States
- Study dates
- 14 Oct 2004to 2 Mar 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subject has moderate or severe hemophilia A (baseline FVIII less than or equal to 5%)
- Subject currently has no measurable FVIII inhibitor titer greater than or equal to 1 BU (Bethesda or Nijmegen method)
- Subject has been prescribed ADVATE by their treating physician
- Subject may be of any age
- Subject or parent/legally authorized representative has provided written informed consent
Who cannot join
- None
Trial locations and contacts
37 sites in 1 country.
37 sites in 1 country
United States37 sites
Phs Childrens Hosp Med Ctr Akron
Akron, Ohio, 44308
Ted R. Montoya Hemophilia Treatment Center
Albuquerque, New Mexico, 87131
University of Michigan Med. Ctr Htc
Ann Arbor, Michigan, 48109
The Johns Hopkins Hospital
Baltimore, Maryland, 21205
Rush Presbyterian - St. Lukes Medical Center
Chicago, Illinois, 60612
Children´s Memorial Hospital
Chicago, Illinois, 60614
Children´s Hospital Medical Center Pharmacy, Hemophilia Treatment Center
Cincinnati, Ohio, 45229
Henry Ford Hospital
Detroit, Michigan, 48202
City of Hope National Medical Center
Duarte, California, 91010
Children'S Hospital of S.W. Florida
Fort Myers, Florida, 33908
PHS DEVOS CHILDRENS Hospital
Grand Rapids, Michigan, 49503
BIODORON
Hollywood, Florida, 33021
Baylor College of Medicine
Houston, Texas, 77030
Indiana Hemophilia & Thrombosis Center
Indianapolis, Indiana, 46260
University of Iowa Hospitals and Clinics, Iowa Regional Hemophilia Center, Department of Pediatrics
Iowa City, Iowa, 52242
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Nemours Children'S Clinic
Jacksonville, Florida, 32207
University of Tennessee Medical Center
Knoxville, Tennessee, 37920-6999
Arkansas Childrens Hospital
Little Rock, Arkansas, 72202
LONG BEACH MEMORIAL MED Center
Long Beach, California, 90806
Children´s Hospital Los Angeles, Hemophilia Comprehensive Care Center, Division of Pediatric Hematology/Oncology
Los Angeles, California, 90027
Valley Children'S Hospital
Madera, California, 93638
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08901
Tulane Univ Hosp & Clinic
New Orleans, Louisiana, 70112
Children'S Hospital of the King'S Daughters
Norfolk, Virginia, 23507
NEMOURS CHILDREN'S CLINIC- Orlando
Orlando, Florida, 32801
Childrens Hosp of Philadelphia
Philadelphia, Pennsylvania, 19104
Presbyterian Medical Center
Philadelphia, Pennsylvania, 19104
St. Christopher´s Hospital for Children, Section of Hematology/Oncology
Philadelphia, Pennsylvania, 19134-1095
PHOENIX CHILDRENS Hospital
Phoenix, Arizona, 85016
Phs-So Tx Hemo Ctr-San Antonio
San Antonio, Texas, 78207
St. Louis Children'S Hospital
St Louis, Missouri, 63110
Tampa Children'S Hospital At St. Joes
Tampa, Florida, 33607
University of Southern Florida
Tampa, Florida, 33612
MUNSON MED Center
Traverse City, Michigan, 49684
North Carolina Baptist Hospital, Hematology/Oncology Medical Center Boulevard
Winston-Salem, North Carolina, 27157
Youngstown HTC
Youngstown, Ohio, 44501
About this study
Official title: Evaluation of Safety, Efficacy, and Immunogenicity of ADVATE in Hemophilia A- An ADVATE Post-authorization Safety Surveillance (PASS) Study
The primary objective of this post-authorization safety surveillance is to measure the incidence of adverse events that are at least possibly related to ADVATE use, in subjects receiving ADVATE in routine clinical practice.
- Conditions
- Hemophilia A
- Being tested
- rAHF-PFM
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rAHF-PFMDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study start14 Oct 2004
- Study completion2 Mar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemophilia AStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baxalta now part of Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Baxter BioScience
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00214734
- Sponsor's protocol ID
- ADVATE PASS
- Status last verified
- Mar 2021
- First submitted
- 15 Sep 2005
- Last updated
- 17 Mar 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety, Efficacy, and Immunogenicity of ADVATE in Hemophilia A- An ADVATE Post-authorization Safety Surveillance (PASS) Study
- ClinicalTrials.gov ID
- NCT00214734
- Acronym / sponsor ID
- ADVATE PASS
- Conditions
- Hemophilia A
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Baxalta now part of ShireIndustry (pharma, biotech, devices)
- Collaborators
- Baxter BioScience
- Study start
- 14 Oct 2004 (actual)
- Study completion
- 2 Mar 2007 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this post-authorization safety surveillance is to measure the incidence of adverse events that are at least possibly related to ADVATE use, in subjects receiving ADVATE in routine clinical practice.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Subject has moderate or severe hemophilia A (baseline FVIII less than or equal to 5%)
- Subject currently has no measurable FVIII inhibitor titer greater than or equal to 1 BU (Bethesda or Nijmegen method)
- Subject has been prescribed ADVATE by their treating physician
- Subject may be of any age
- Subject or parent/legally authorized representative has provided written informed consent
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rAHF-PFM | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- To obtain more information on the study, click here/on this link.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Study Director study director
Takeda
37 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemophilia A, run by Baxalta now part of Shire at 37 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2021.