RECRUITING

Nuwiq for Perioperative Management Of Patients With Haemophilia A on Emicizumab Regular Prophylaxis Study

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Conditions

Severe 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 patients with severe haemophilia A undergoing major surgery while receiving emicizumab prophylaxis

Official Title

Nuwiq for Perioperative Management Of Patients With Haemophilia A on Emicizumab Regular Prophylaxis Study (NuPOWER)

Quick Facts

Study Start:2023-11-28
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05935358

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:MALE
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Severe haemophilia A (FVIII activity \[FVIII:C\] \<1%) according to medical history
  2. * Male patients at least 12 years of age
  3. * Previous treatment with any FVIII product(s) for at least 150 exposure days
  4. * On regular prophylaxis with emicizumab for at least 1 month prior to a scheduled major elective surgery requiring FVIII treatment
  5. * Freely given written informed consent of the patient, or parent/legal representative where applicable, obtained in accordance with local regulations
  1. * Coagulation disorder other than haemophilia A
  2. * Present or past FVIII inhibitor (≥0.6 Bethesda units \[BU\]/mL) according to medical history
  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. * Known hypersensitivity to Nuwiq's active substance or its excipients (sucrose, sodium chloride, calcium chloride dihydrate, arginine hydrochloride, sodium citrate dihydrate, poloxamer 188)
  5. * Already had surgery in this study
  6. * Current participation in another interventional clinical trial
  7. * Treatment with any investigational medicinal product (IMP) within 30 days prior to screening visit

Contacts and Locations

Study Contact

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

Principal Investigator

Shveta Gupta, MD
PRINCIPAL_INVESTIGATOR
Arnold Palmer Hospital for Children

Study Locations (Sites)

UT Southwestern Medical Center
Dallas, Texas, 75390
United States

Collaborators and Investigators

Sponsor: Octapharma

  • Shveta Gupta, MD, PRINCIPAL_INVESTIGATOR, Arnold Palmer Hospital for Children

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 Date2023-11-28
Study Completion Date2025-12

Study Record Updates

Study Start Date2023-11-28
Study Completion Date2025-12

Terms related to this study

Additional Relevant MeSH Terms

  • Severe Hemophilia A