NCT05147662 - A Study to Learn How Safe the Study Treatment BAY94-9027 is and How it Affects the Body in Previously Treated Children Aged 7 to Less Than 12 Years With Severe Hemophilia A, a Genetic Bleeding Disorder That is Caused by the Lack of a Protein Called Clotting Factor 8 (FVIII) in the Blood | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

March 23, 2022

Primary Completion Date

January 4, 2024

Study Completion Date

May 21, 2025

Conditions

Treatment of BleedingProphylaxis of BleedingHemophilia AChildren

Interventions

BIOLOGICAL

Damoctocog alfa pegol (Jivi, BAY94-9027)

"Part A: 40 IU/kg (up to 60 IU/kg at the investigator's discretion), two times per week (2x/week) with the first 4 infusions under medical supervision. Thereafter, participants will continue their treatment as home treatment. Dose may be increased up to 60 IU/kg if needed at any time during the study at the investigator's discretion.~Part B: Each participant may continue on prophylaxis dose regimen as prescribed in part A (40 - 60 IU/kg, 2x per week) or adjustments to prophylaxis dose / dose frequency can be made at the investigator's discretion (based on the bleeding events and individual needs): Dose frequency may be decreased to every 5 days with a prophylaxis dose of 60 IU/kg."

Trial Locations (23)

372

OUS Rikshospitalet Klinisk Forskningspost Barn, Oslo

1900

Hospital de Niños Sor María Ludovica, La Plata

5501

Instituo Hematología Arbesú, Godoy Cruz

7059

Akdeniz Universitesi Tip Fakultesi Hastanesi, Antalya

27100

Gaziantep Üniversitesi Tip Fakültesi, Sahinbey Arastirma Ve Uygulama Hastanesi, Çocuk Hematoloji ve Onkoloji Bilim Dali, Gaziantep

32806

Arnold Palmer Hospital for Children, Orlando

35100

Ege Üniversitesi Tip Fakültesi, Çocuk Sagligi ve Hastaliklari Anabilim Dali, Çocuk Hematoloji Bilim Dali, Izmir

55200

Ondokuz Mayis Üniversitesi Tip Fakültesi, Saglik Uygulama ve Arastirma Merkezi, Çocuk Sagligi ve Hastaliklari Anabilim Dali, Samsun

80122

AORN Santobono-Pausilipon, Napoli

C1015ABO

Organizacion Medica de Investigacion (OMI), Buenos Aires

S2000CKF

Instituto de Hematología Dr. Rubén Dávoli, Rosario

20211-030

HEMORIO, Rio de Janeiro

13083-878

Hospital das Clínicas de Campinas - UNICAMP, Campinas

14051-140

Hosp Clínicas Facult. Med. de Ribeirão Preto / USP, Ribeirão Preto

01223-001

Irmandadade da Santa Casa de Misericordia de Sao Paulo (iSANTACASA), São Paulo

Unknown

Many Locations, Multiple Locations

T3B 6A8

Alberta Children's Hospital - Hematology / Oncology / Blood and Marrow Transplant Clinic, Calgary

L8N 3Z5

McMaster Children's Hospital, Hamilton

00165

Ospedale Pediatrico Bambino Gesù - Oncoematologia, Trapianto Emopoietico e Terapie Cellulari, Roma (RM)

01130

Acibadem Adana Hastanesi, Çocuk Sagligi ve Hastaliklari, Çocuk Hematoloji-Onkoloji Bölümü, Adana

06230

Hacettepe Üniversitesi Tip Fakültesi, Hacettepe Ihsan Dogramaci Çocuk Hastanesi,, Ankara