Treatment of Congenital Factor VII Deficiency (F7CONDEF)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01779921
First received: January 15, 2013
Last updated: June 24, 2014
Last verified: June 2014

January 15, 2013
June 24, 2014
October 2005
January 2012   (final data collection date for primary outcome measure)
  • Treatment of bleeding episodes at clinic/hospital: Treatment efficacy evaluation for each treatment modality: excellent, effective, partly effective, ineffective, or not evaluable [ Time Frame: Evaluated at 6 hours ] [ Designated as safety issue: No ]
  • Treatment of bleeding episodes at clinic/hospital: Treatment efficacy evaluation for each treatment modality: excellent, effective, partly effective, ineffective, or not evaluable [ Time Frame: Evaluated after 30 days ] [ Designated as safety issue: No ]
  • Treatment of bleeding episodes at clinic/hospital: Time to achieve arrest of bleeding [ Time Frame: Time to achieve arrest of bleeding ] [ Designated as safety issue: No ]
  • Treatment of bleeding episodes at clinic/hospital: Number of re-bleeding episodes [ Time Frame: Within 5 days after first product administration ] [ Designated as safety issue: No ]
  • Treatment of bleeding episodes at home: Treatment efficacy evaluation for each treatment modality: excellent, effective, partly effective, ineffective, or not evaluable [ Time Frame: Evaluated at 6 hours ] [ Designated as safety issue: No ]
  • Treatment of bleeding episodes at home: Time to achieve arrest of bleeding [ Time Frame: Time to achieve arrest of bleeding ] [ Designated as safety issue: No ]
  • Treatment efficacy (of first and/or second treatment modality) evaluated after surgery: good, partially effective, not evaluable, or ineffective [ Time Frame: After surgery ] [ Designated as safety issue: No ]
  • Treatment efficacy (of first and/or second treatment modality) evaluated after surgery: good, partially effective, not evaluable, or ineffective [ Time Frame: Evaluated after 30 days ] [ Designated as safety issue: No ]
  • Estimated blood loss volume [ Time Frame: During surgery/delivery ] [ Designated as safety issue: No ]
  • Number of red blood cell units administered [ Time Frame: During surgery ] [ Designated as safety issue: No ]
  • Number of days spent in hospital [ Time Frame: Until last data collection (20 Jan 2012) ] [ Designated as safety issue: No ]
  • Number of re-bleeding episodes (associated with the surgery) [ Time Frame: Within 5 days after surgery ] [ Designated as safety issue: No ]
  • Prophylactic treatment efficacy evaluation: excellent, excellent, partially effective, or effective [ Time Frame: 30 days after first prophylaxis dose ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01779921 on ClinicalTrials.gov Archive Site
  • Number of bleeding episodes during prophylaxis per year [ Time Frame: Up to one year ] [ Designated as safety issue: No ]
  • Number of intensive care unit (ICU) and/or the number of ward days [ Time Frame: After first haemostatic product administration until day 30 ] [ Designated as safety issue: No ]
  • Mortality [ Time Frame: Within a 30-day (follow-up) period ] [ Designated as safety issue: Yes ]
  • Changes in laboratory parameters (prothombin time/international normalized ratio, activated partial thromboplastin time, FVII clotting activity, platelet count, fibrinogen) [ Time Frame: Prior to dosing ] [ Designated as safety issue: No ]
  • Changes in laboratory parameters (prothombin time/international normalized ratio, activated partial thromboplastin time, FVII clotting activity, platelet count, fibrinogen) [ Time Frame: After 15 minutes ] [ Designated as safety issue: No ]
  • Changes in laboratory parameters (prothombin time/international normalized ratio, activated partial thromboplastin time, FVII clotting activity, platelet count, fibrinogen) [ Time Frame: After 30 days ] [ Designated as safety issue: No ]
  • Presence of and/or de novo appearance of inhibiting antibodies to FVII [ Time Frame: Prior to dosing ] [ Designated as safety issue: Yes ]
  • Presence of and/or de novo appearance of inhibiting antibodies to FVII [ Time Frame: After 30 days ] [ Designated as safety issue: Yes ]
  • Number of Adverse Events [ Time Frame: Until Day 5 ] [ Designated as safety issue: No ]
  • Number of Serious Adverse Events [ Time Frame: Until Day 30 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Treatment of Congenital Factor VII Deficiency
Treatment of Congenital Factor VII Deficiency. A Prospective Observational Study

This study is conducted globally. The aim of this study is to describe the treatment modalities and outcomes of bleeding episodes, surgery and prophylaxis in patients with factor VII (FVII) deficiency in addition to evaluate the presence (in already treated patients) and/or the appearance of inhibiting antibodies to FVII and/or therapy-related thrombosis.

Due to a Novo Nordisk commitment to the Committee for Medicinal Products for Human Use (CHMP), Novo Nordisk receives data on treatment with activated recombinant human FVII (rFVIIa, NovoSeven®) in patients with FVII deficiency from the Seven Treatment Evaluation Registry (STER, NCT01269138). These patients can also have been treated with other haemostatics for systemic administration.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Plasma for assaying of inhibiting antibodies to FVII. All samples, which are analysed at the local hospital laboratory, are to be stored and destroyed according to local rules. Inhibitor samples analysed at the central laboratory will be stored until data validation has taken place at the end of the study after which the samples will be destroyed.

Non-Probability Sample

Patients with FVII deficiency (levels of FVII less than 50% of normal or a mutation known to be associated to a FVII deficiency) can be enrolled.

  • Congenital Bleeding Disorder
  • Congenital FVII Deficiency
  • Drug: activated recombinant human factor VII
    Treatment of bleeding episodes and treatment during surgery and prophylaxis as per discretion of the investigator.
  • Drug: Fresh frozen plasma (Source unspecified)
    Treatment of bleeding episodes and treatment during surgery and prophylaxis as per discretion of the investigator.
  • Drug: Plasma-derived FVII (LFB)
    Treatment of bleeding episodes and treatment during surgery and prophylaxis as per discretion of the investigator.
  • Drug: Prothrombin Complex conc. (PCC)
    Treatment of bleeding episodes and treatment during surgery and prophylaxis as per discretion of the investigator.
  • Drug: Plasma-derived FVII conc. (pdFVII Baxter)
    Treatment of bleeding episodes and treatment during surgery and prophylaxis as per discretion of the investigator.
  • Drug: Plasma-derived FVII conc. (pdFVII PFL)
    Treatment of bleeding episodes and treatment during surgery and prophylaxis as per discretion of the investigator.
FVII
Interventions:
  • Drug: activated recombinant human factor VII
  • Drug: Fresh frozen plasma (Source unspecified)
  • Drug: Plasma-derived FVII (LFB)
  • Drug: Prothrombin Complex conc. (PCC)
  • Drug: Plasma-derived FVII conc. (pdFVII Baxter)
  • Drug: Plasma-derived FVII conc. (pdFVII PFL)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
163
January 2012
January 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Signed informed consent by the patient or next of kin or legally acceptable representative to collect data on treatment of a given bleeding episode, surgical event or prophylactic regimen as specified in the protocol. If informed consent is provided by the next of kin or legally acceptable representative, consent must also be obtained from the patient as soon as he/she is able to do so. Informed consent should preferentially be obtained before initiation of treatment or as a minimum before entry of data into the database
  • Any patient with a FVII deficiency for whom treatment of bleeding episodes, prevention related to surgery and primary/secondary prophylaxis is considered necessary by the treating physician can be enrolled
  • Patients with FVII deficiency without any immediate need for treatment will be entered as stand by registered patients with capture of baseline- and demographic data only. Admission data is entered once an event occurs
Both
up to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   France,   Germany,   Greece,   Hong Kong,   India,   Iran, Islamic Republic of,   Israel,   Italy,   Pakistan,   Serbia,   Slovakia,   Spain,   Thailand,   Turkey,   Venezuela
 
NCT01779921
F7HAEM-3578
No
Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
Novo Nordisk A/S
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP