Relative Bioavailability Of Two Formulations Of Moroctocog Alfa (AF-CC)
NCT01579903
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- Male patients at least 18 years old with severe or moderately severe hemophilia A (facto VIII concentration less than or equal to 2%).
- Negative test for facto VIII inhibitor.
- If applicable, HIV or hepatitis treatment is stable at the time of enrollment.
- Ability to abstain from use of FVIII products for 72 hours at a time.
- History of any positive test result for factor VIII inhibitor.
- Presence of any bleeding disorder in addition to Hemophilia A.
- Body weight less than 50 kg.
- History of alcoholism.
- Treatment with investigational drug or device within 30 days prior to the Screening
visit.
NEED INFO?
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
TRY A NEW SEARCH
Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.
Based on your search, you may also be interested in
- Surat, Gujarat
- Mumbai, Maharashtra
- Pune, Maharashtra
- Pune, Maharashtra
- Ludhiana, Punjab
- San Francisco, California
- San Francisco, California
- San Francisco, California
- San Francisco, California
- Seattle, Washington
- Seattle, Washington
- LaJolla, California
- Detroit, Michigan
- Detroit, Michigan
- Chapel Hill, North Carolina
- Hershey, Pennsylvania
- Pittsburg, Pennsylvania
- Houston, Texas
- Charlottesville, Virginia
- Perth,
- Vienna,
- Budapest,
- Auckland,
- Chirstchurch,
- Warsawa,
- Bucurest,
- Malmö,
- Stockholm,
Descriptive Information | ||||
---|---|---|---|---|
Brief Title ICMJE | Relative Bioavailability Of Two Formulations Of Moroctocog Alfa (AF-CC) | |||
Official Title ICMJE | An Open-Label, Randomized, Two-period Crossover Study To Compare Relative Bioavailability of Two Formulations of Moroctocog Alfa (Af-cc) In Subjects With Moderately Severe Or Severe Hemophilia A (FVIII:C </=2%) | |||
Brief Summary | This study is being conducted to compare how moroctocog alfa (AF-CC) acts in the body when administered as 2 different dose presentations. The first is the current product vials with prefilled diluent syringes and the second is a new dual-chamber syringe dose presentation. | |||
Detailed Description | This study is being conducted in order to satisfy a post-approval EMA commitment to compare the pharmacokinetics of the 2 dose presentations used in this study. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: None (Open Label) | |||
Condition ICMJE | Hemophilia A | |||
Intervention ICMJE |
| |||
Study Arms ICMJE |
| |||
Publications * | Shafer F, Charnigo RJ, Plotka A, Baumann J, Liang Y, Korth-Bradley J. Assessment of relative bioavailability of two presentations of moroctocog alfa (AF-CC) in subjects with moderately severe or severe hemophilia A. Clin Pharmacol Drug Dev. 2015 May-Jun;4(3):237-41. doi: 10.1002/cpdd.168. Epub 2014 Oct 27. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE | 16 | |||
Original Estimated Enrollment ICMJE | 18 | |||
Actual Study Completion Date ICMJE | January 2013 | |||
Actual Primary Completion Date | January 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Bulgaria, Hungary, United Kingdom | |||
Removed Location Countries | Belgium, Greece, Poland | |||
Administrative Information | ||||
NCT Number ICMJE | NCT01579903 | |||
Other Study ID Numbers ICMJE | B1831077 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | February 2013 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |