RECRUITING

Nuwiq Dosing and Outcomes In the ManagEment of Women/Girls With Haemophilia A Needing FVIII Treatment for Surgery

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Conditions

Hemophilia 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

Recombinant factor VIII for the prevention of bleeding in women/girls with haemophilia A undergoing major surgery

Official Title

Nuwiq Dosing and Outcomes In the ManagEment of Women/Girls With Haemophilia A Needing FVIII Treatment for Surgery - an International, Open-label, Non-controlled Study (NuDIMENSION)

Quick Facts

Study Start:2025-01
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05936580

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:12 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Women/girls with haemophilia A (FVIII:C ≥1-\<40%) according to medical history
  2. 2. At least 12 years of age
  3. 3. Scheduled to undergo major elective surgery requiring FVIII treatment
  4. 4. Freely given written informed consent of the patient, or parent/legal representative where applicable, obtained in accordance with local regulations
  1. 1. Coagulation disorder other than haemophilia A
  2. 2. Present or past FVIII inhibitor (≥0.6 Bethesda units \[BU\]/mL)
  3. 3. Severe liver or kidney disease (alanine aminotransferase \[ALT\] and/or aspartate aminotransferase \[AST\] levels \>5 times the upper limit of normal; or creatinine \>120 μmol/L)
  4. 4. Known hypersensitivity to Nuwiq's active substance or its excipients (sucrose, sodium chloride, calcium chloride dihydrate, arginine hydrochloride, sodium citrate dihydrate, poloxamer 188)
  5. 5. Pregnancy
  6. 6. Already had surgery in this study
  7. 7. Current participation in another interventional clinical trial
  8. 8. Treatment with any investigational medicinal product (IMP) within 30 days prior to screening visit

Contacts and Locations

Study Contact

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

Principal Investigator

Johannes Oldenburg
PRINCIPAL_INVESTIGATOR
Experimental Haematology and Transfusion Medicine, University Clinic Bonn

Study Locations (Sites)

UT Health San Antonio
San Antonio, Texas, 78229
United States

Collaborators and Investigators

Sponsor: Octapharma

  • Johannes Oldenburg, PRINCIPAL_INVESTIGATOR, Experimental Haematology and Transfusion Medicine, University Clinic Bonn

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 Date2025-01
Study Completion Date2025-12

Study Record Updates

Study Start Date2025-01
Study Completion Date2025-12

Terms related to this study

Additional Relevant MeSH Terms

  • Hemophilia A