You are here

Study Evaluating BENEFIX in Previously Treated Patients With Hemophilia B

Last updated on May 10, 2018

FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hemophilia B
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
6+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

1. Patients with moderate to severe hemophilia B ( having acute hemorrhage or requiring "short-term therapy" for intermittent secondary
prophylaxis regimens.

2. HIV seropositive ( asymptomatic) or seronegative subjects.

3. No history or detectable inhibitors.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

1. Patients with moderate to severe hemophilia B ( having acute hemorrhage or requiring "short-term therapy" for intermittent secondary
prophylaxis regimens.

2. HIV seropositive ( asymptomatic) or seronegative subjects.

3. No history or detectable inhibitors.

NCT00581126
Pfizer
Completed
Study Evaluating BENEFIX in Previously Treated Patients With Hemophilia B

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.

Similar Trials

Avelumab in Combination With Talazoparib Will be Investigated in Patients With Locally Advanced (Primary or Recurrent) or Metastatic Solid Tumors
NCT03330405
All Genders
18+
Years
Multiple Sites
Study Evaluating BENEFIX in Previously Treated Patients With Hemophilia B
Evaluation of Efficacy and Safety of Benefix®- Coagulation Factor ix, Recombinant, in Previously Treated Patients With Hemophilia b.
To assess efficacy and safety of BeneFix® for prophylaxis in "Short-term" therapy and on demand therapy for all bleeding episodes of subjects with hemophilia B.

Phase IV, open-label, non comparative, multicenter, previously treated patients (PTP) clinical trial. Patients with severe or moderate hemophilia B with baseline levels of plasma factor IX < 5% activity will participate in this study for both treatment regimens: "on demand" therapy for acute bleeding episodes and therapy for prophylaxis of bleeding episodes ( "Short-term therapy")*.

* Short-Term Therapy: Prophylactic therapy given before surgery, including dental procedures, prior to a event that would likely result in bleeding ( sports, exercise, or heavy work), as well as to prevent further bleeds into a target joint). This short-term therapy for intermittent secondary therapy.

Interventional
Phase 4
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hemophilia B
Drug: Recombinant Factor IX Coagulation
Benefix IV each 12 hours for 2 a 5 days
Experimental: 1
Patients will receive Benefix IV according to blood amount
Intervention: Drug: Recombinant Factor IX Coagulation
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
July 2004
Not Provided

Inclusion Criteria:

  1. Patients with moderate to severe hemophilia B ( < 5% circulating factor IX activity) having acute hemorrhage or requiring "short-term therapy" for intermittent secondary prophylaxis regimens.
  2. HIV seropositive ( asymptomatic) or seronegative subjects.
  3. No history or detectable inhibitors.
Sexes Eligible for Study: All
6 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00581126
3090A-100932
No
Not Provided
Not Provided
Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
December 2007

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now