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NCT Number: NCT01779921

Treatment of Congenital Factor VII Deficiency

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.

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Key information

Conditions

Congenital Bleeding Disorder Congenital FVII Deficiency

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Investigational Site, Paris La Défense Cedex, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

activated recombinant human factor VII

Drug

Treatment of bleeding episodes and treatment during surgery and prophylaxis as per discretion of the investigator.

Fresh frozen plasma (Source unspecified)

Drug

Treatment of bleeding episodes and treatment during surgery and prophylaxis as per discretion of the investigator.

Plasma-derived FVII (LFB)

Drug

Treatment of bleeding episodes and treatment during surgery and prophylaxis as per discretion of the investigator.

Prothrombin Complex conc. (PCC)

Drug

Treatment of bleeding episodes and treatment during surgery and prophylaxis as per discretion of the investigator.

Plasma-derived FVII conc. (pdFVII Baxter)

Drug

Treatment of bleeding episodes and treatment during surgery and prophylaxis as per discretion of the investigator.

Plasma-derived FVII conc. (pdFVII PFL)

Drug

Treatment of bleeding episodes and treatment during surgery and prophylaxis as per discretion of the investigator.

Primary outcomes

  1. 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

  2. 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

  3. Treatment of bleeding episodes at clinic/hospital: Time to achieve arrest of bleeding

    Time frame: Time to achieve arrest of bleeding

  4. Treatment of bleeding episodes at clinic/hospital: Number of re-bleeding episodes

    Time frame: Within 5 days after first product administration

  5. 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

  6. Treatment of bleeding episodes at home: Time to achieve arrest of bleeding

    Time frame: Time to achieve arrest of bleeding

  7. Treatment efficacy (of first and/or second treatment modality) evaluated after surgery: good, partially effective, not evaluable, or ineffective

    Time frame: After surgery

  8. 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

  9. Estimated blood loss volume

    Time frame: During surgery/delivery

  10. Number of red blood cell units administered

    Time frame: During surgery

  11. Number of days spent in hospital

    Time frame: Until last data collection (20 Jan 2012)

  12. Number of re-bleeding episodes (associated with the surgery)

    Time frame: Within 5 days after surgery

  13. Prophylactic treatment efficacy evaluation: excellent, excellent, partially effective, or effective

    Time frame: 30 days after first prophylaxis dose

Secondary outcomes

  1. Number of bleeding episodes during prophylaxis per year

    Time frame: Up to one year

  2. Number of intensive care unit (ICU) and/or the number of ward days

    Time frame: After first haemostatic product administration until day 30

  3. Mortality

    Time frame: Within a 30-day (follow-up) period

  4. Changes in laboratory parameters (prothombin time/international normalized ratio, activated partial thromboplastin time, FVII clotting activity, platelet count, fibrinogen)

    Time frame: Prior to dosing

  5. Changes in laboratory parameters (prothombin time/international normalized ratio, activated partial thromboplastin time, FVII clotting activity, platelet count, fibrinogen)

    Time frame: After 15 minutes

  6. Changes in laboratory parameters (prothombin time/international normalized ratio, activated partial thromboplastin time, FVII clotting activity, platelet count, fibrinogen)

    Time frame: After 30 days

  7. Presence of and/or de novo appearance of inhibiting antibodies to FVII

    Time frame: Prior to dosing

  8. Presence of and/or de novo appearance of inhibiting antibodies to FVII

    Time frame: After 30 days

  9. Number of Adverse Events

    Time frame: Until Day 5

  10. Number of Serious Adverse Events

    Time frame: Until Day 30

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study title

Treatment of Congenital Factor VII Deficiency. A Prospective Observational Study

Acronym: F7CONDEF

Important dates

Study start
2005
Primary completion
2012
Study completion
2012
First posted
Jan 30, 2013
Registry last updated
Jan 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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