RECRUITING

Efficacy, Safety & Utilisation of Nuwiq, Octanate and Wilate in Previously Untreated & Minimally Treated Haemophilia a Patients

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Conditions

Haemophilia a

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

International, post-authorisation non-interventional study to evaluate real-life effectiveness, safety and utilisation patterns of Octapharma's FVIII concentrates Nuwiq, Octanate, and Wilate in previously untreated and minimally treated severe haemophilia A patients in routine clinical practice.

Official Title

Practical Utilisation of Octapharma FVIII Concentrates in Previously Untreated & Minimally Treated Haemophilia a Patients Entering Routine Clinical Treatment with Nuwiq, Octanate or Wilate - Efficacy & Safety Observational Study-Protect-NOW

Quick Facts

Study Start:2018-02-13
Study Completion:2030-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03695978

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male and female patients of any age and ethnicity
  2. * Severe haemophilia A (FVIII:C\<1%)
  3. * Decision to prescribe Octapharma's FVIII concentrate before enrollment into the study
  4. * Either
  5. * No previous treatment with FVIII concentrates or other blood products containing FVIII (PUPs) OR
  6. * Less than 5 Exposure Days (EDs) to FVIII concentrates or other blood products containing FVIII (MTPs), if
  7. * data are available on all previous treatment, AND
  8. * they did not develop an inhibitor at any time point, OR
  9. * they developed an inhibitor during treatment with an Octapharma FVIII concentrate AND continue treatment with THIS Octapharma FVIII concentrate (in the presence or absence of emicizumab).
  10. * Voluntarily given, fully informed written and signed consent obtained before any study-related data documentation is conducted (obtained from the patient's parent/legal guardian)
  1. * Diagnosis with a coagulation disorder other than haemophilia A
  2. * Concomitant treatment with any systemic immunosuppressive drug
  3. * Participation in an interventional clinical trial during the time period evaluated
  4. * Participation in another non-interventional study of Octapharma

Contacts and Locations

Study Contact

Sigurd Knaub, PhD
CONTACT
+41 554512141
Sigurd.Knaub@octapharma.ch

Principal Investigator

Sigurd Knaub, PhD
STUDY_DIRECTOR
Octapharma

Study Locations (Sites)

Cure 4 The Kids Foundation Children's Specialty Center
Las Vegas, Nevada, 89109
United States

Collaborators and Investigators

Sponsor: Octapharma

  • Sigurd Knaub, PhD, STUDY_DIRECTOR, Octapharma

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-02-13
Study Completion Date2030-06

Study Record Updates

Study Start Date2018-02-13
Study Completion Date2030-06

Terms related to this study

Additional Relevant MeSH Terms

  • Haemophilia a