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A Study of Safety and Effectiveness of NovoThirteen® (rFXIII) During Treatment of Congenital FXIII Deficiency in Japan

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02670213
Recruitment Status : Enrolling by invitation
First Posted : February 1, 2016
Last Update Posted : March 9, 2020
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This study is conducted in Asia. Tha aim of this study is to investigate Safety and Effectiveness of NovoThirteen® (rFXIII) during treatment of congenital FXIII deficiency in Japan.

Condition or disease Intervention/treatment
Congenital Bleeding Disorder Congenital FXIII Deficiency Drug: recombinant factor XIII

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Study Type : Observational
Estimated Enrollment : 8 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multicentre, Non-interventional Post Marketing Study of Safety and Effectiveness of NovoThirteenR (rFXIII) During Treatment of Congenital FXIII Deficiency in Japan
Actual Study Start Date : March 16, 2016
Estimated Primary Completion Date : September 30, 2024
Estimated Study Completion Date : September 30, 2024

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
NovoThirteen® Drug: recombinant factor XIII
No treatment given.Patients will be treated according to routine clinical practice at the discretion of the treating physician.




Primary Outcome Measures :
  1. Adverse drug reactions in patients with congenital FXIII A-subunit deficiency treated with NovoThirteen®, comprising FXIII antibodies, allergic reactions, embolic and thrombotic events and lack of therapeutic effect [ Time Frame: Year 0-9 ]

Secondary Outcome Measures :
  1. All serious adverse events [ Time Frame: Year 0-9 ]
  2. All adverse events [ Time Frame: Year 0-9 ]
  3. All medical event of special interest [ Time Frame: Year 0-9 ]
  4. All medication errors collected [ Time Frame: Year 0-9 ]
  5. All technical complaints [ Time Frame: Year 0-9 ]
  6. Use of NovoThirteen® for other uses than for the approved indication [ Time Frame: Year 0-9 ]
  7. Frequency of bleeding episodes [ Time Frame: Year 0-9 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Male or female patients, regardless of age, requiring treatment with NovoThirteenR at the discretion of the treating physician
Criteria

Inclusion Criteria:

  • Male of female patients, regardless of age, requiring treatment with NovoThirteenR for whom the treating physician has decided to use NovoThirteenR (rFXIII) treatment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02670213


Locations
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Japan
Novo Nordisk Investigational Site
Aichi, Japan, 466-8560
Novo Nordisk Investigational Site
Gamagori-shi, Aichi, Japan, 443-8501
Novo Nordisk Investigational Site
Hiroshima, Japan, 720-0001
Novo Nordisk Investigational Site
Kure-shi, Hiroshima, Japan, 737-0023
Novo Nordisk Investigational Site
Muroran, Hokkaido,, Japan, 051-8501
Novo Nordisk Investigational Site
Shiga, Japan, 520-1121
Novo Nordisk Investigational Site
Tokyo, Japan, 167-0035
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Additional Information:
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT02670213    
Other Study ID Numbers: NN1841-4211
U1111-1162-5426 ( Other Identifier: WHO )
First Posted: February 1, 2016    Key Record Dates
Last Update Posted: March 9, 2020
Last Verified: March 2020
Additional relevant MeSH terms:
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Hemostatic Disorders
Blood Coagulation Disorders
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders