Safety and Pharmacokinetics of Recombinant Factor XIII in Patients With Congenital Factor Xlll Deficiency
This study has been completed.
Sponsor:
Novo Nordisk
Information provided by (Responsible Party):
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00056589
First received: March 18, 2003
Last updated: May 2, 2013
Last verified: May 2013
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Purpose
This trial was conducted in the United States of America (USA). The aim of this trial was to investigate safety and pharmacokinetics of escalating single doses of recombinant factor XIII (rFXIII) in patients with congenital factor XIII deficiency.
| Condition | Intervention | Phase |
|---|---|---|
|
Congenital Bleeding Disorder Congenital FXIII Deficiency |
Drug: recombinant factor XIII |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 1 Escalating Dose Study of the Safety and Pharmacokinetics of Recombinant Factor XIII in Patients With Congenital Factor XIII Deficiency |
Resource links provided by NLM:
MedlinePlus related topics:
Bleeding Disorders
Drug Information available for:
Factor XIII
U.S. FDA Resources
Further study details as provided by Novo Nordisk:
Primary Outcome Measures:
- Incidence of adverse events [ Time Frame: Days 0-28 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Incidence of clinically significant changes from baseline in physical examination or laboratory measurements [ Time Frame: Days 0-28 ] [ Designated as safety issue: No ]
- Incidence of rFXIII antibodies, as measured by ELISA (Enzyme-Linked Immuno Sorbent Assay) [ Time Frame: Days 0-28 ] [ Designated as safety issue: No ]
- Incidence of yeast antibodies [ Time Frame: Days 0-28 ] [ Designated as safety issue: No ]
- FXIII activity measured by the Berichrom® assay [ Time Frame: Days 0-28 ] [ Designated as safety issue: No ]
| Enrollment: | 11 |
| Study Start Date: | March 2003 |
| Study Completion Date: | October 2003 |
| Primary Completion Date: | October 2003 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: rFXIII |
Drug: recombinant factor XIII
Single doses of rFXIII administered intravenously (IV) to two subjects in each of the five dose levels (2, 6, 20, 50 and 75 U/kg).
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Documental congenital FXIII deficiency
- Normal platelet count and clotting parameters
- Adequate renal and hepatic function
- If female and of child-bearing potential, negative serum pregnancy test within 7 days of enrollment
- If a sexually active male or a sexually active female of child-bearing potential, agreement to use a medically accepted form of contraception from the time of enrollment to completion of all follow-up study visits
- Negative drug and alcohol screens
Exclusion Criteria:
- Received blood products or FXIII concentrates within 4 weeks of study enrollment
- Known antibodies to FXIII
- Hereditary or acquired coagulation disorder other than FXIII deficiency
- Previous history of autoimmune disorders involving autoantibodies e.g., systemic lupus erythematosus
- Previous history of thromboembolic events e.g., cerebrovascular accident or deep vein thrombosis or administration of any antithrombotic or antiplatelet drugs within 7 days of study enrollment
- Received treatment with any experimental agent within 30 days of study enrollment
- Any surgical procedure in the 30 days prior to enrollment
- Donated blood within 30 days prior to enrollment
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00056589
Locations
| United States, California | |
| Novo Nordisk Clinical Trial Call Center | |
| Los Angeles, California, United States, 90027 | |
Sponsors and Collaborators
Novo Nordisk
Investigators
| Study Director: | Global Clinical Registry (GCR, 1452) | Novo Nordisk |
More Information
Additional Information:
No publications provided
| Responsible Party: | Novo Nordisk |
| ClinicalTrials.gov Identifier: | NCT00056589 History of Changes |
| Other Study ID Numbers: | F13-1663 |
| Study First Received: | March 18, 2003 |
| Last Updated: | May 2, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Blood Coagulation Disorders Hemostatic Disorders Hemorrhagic Disorders Factor XIII Deficiency Hemorrhage Hematologic Diseases |
Vascular Diseases Cardiovascular Diseases Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Genetic Diseases, Inborn Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013