Építés alatt – nem éles oldal
Belépés
Résztvevőt keresFázis nélkül

An Observational Study to Learn More About How Well Damoctocog Alfa Pegol Works in Children With Hemophilia A

A legfontosabb adatok

Ki végzi
Bayer
Hol
Many Locations (Japán)A helyszín megnézéseMég 10 másik országban, 11 helyszínen
Azonosító
Állapot
Toboroz
Résztvevők
40 fő, tervezett
Kezdés
2026. júl. 16.
Várható befejezés
2030. márc. 1.
A vizsgálat típusa
Megfigyeléses, 2 csoport
A vizsgált kezelések
  • Damoctocog alfa pegol (Jivi, Bay94-9027)
A regiszteradat frissítve
2026. november 13.

Ki vehet részt

Életkor
7 év – 12 év
Nem
Nők és férfiak
Egészséges önkéntesek
Nem vehetnek részt

A regiszter feltételei, szó szerint

Mind a 13 feltétel megnézéseKevesebb

Ki vehet részt

  • Diagnosis of hemophilia A
  • Patients must be 7 to < 12 years of age at enrollment
  • Patients previously treated for hemophilia A (≥50 exposure days to FVIII) or in those countries with market authorization for the use of damactocog alfa pegol in all patients ≥7 years, patients previously not treated (previously untreated patients (PUPs) or minimally treated (≤4 exposure days (MTPs) with FVIII
  • No current evidence of FVIII inhibitor or clinical suspicion of FVIII inhibitor
  • Patients without a previous history of inhibitors or patients with a previous history of inhibitors on standard prophylaxis therapy for at least 1 year prior to study entry
  • Initiation of prescription or currently prescribed damoctocog alfa pegol for regular continuous prophylaxis (intent to treat for 52 weeks/year)
  • Signed informed consent/assent

Ki nem vehet részt

  • Presence of a FVIII inhibitor
  • Concurrent participation in an investigational program with interventions outside of routine clinical practice
  • Current immune tolerance induction (ITI) treatment for a FVIII inhibitor
  • Diagnosis of any other bleeding/coagulation disorder other than hemophilia A
  • Use of another hemostatic agent as the primary method of bleeding prophylaxis during the observation period
  • Contra-indications according to the local marketing authorization

Nézd meg, megfelelhetsz-e

Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.

  • 7 és 12 év között vagy?

Helyszínek itt: Japán

Még 10 másik országban, 11 helyszínen

  • Many LocationsMany Locations, JapánToborzás még nem indult

A vizsgálatról

Mit akar kideríteni a vizsgálat

This is an observational study of children with mild, moderate, or severe hemophilia A who are receiving damoctocog alfa pegol, and are between 7 to <12 years of age at the time of enrolment. Observational studies use data that are collected as part of routine medical care and participants do not receive any advice or any changes to healthcare as part of the study.

A teljes eredeti leírásKevesebb

In this study, the data will be collected from participants who are starting or already receiving damoctocog alfa pegol as prescribed by their doctor. Participants taking part may have received factor 8 (FVIII) treatment before. The study may also include participants who have never received factor 8 treatment or who have received it only a few times.

Hemophilia A is a genetic bleeding disorder. It is caused by the lack of a protein called clotting factor 8 (FVIII) that helps blood to clot properly. Lack of FVIII can result in excessive blood loss or bleeding inside the body after being injured or having surgery. At times, there is spontaneous bleeding into the joint spaces that leads to joint damage.

The drug observed in this study, damoctocog alfa pegol, is approved for doctors to prescribe to children who are at least 7 years old with hemophilia A. It is used to prevent or treat bleeding episodes and works by replacing missing FVIII in the body of people with hemophilia A.

The participants will receive damoctocog alfa pegol as prescribed independently by their own doctors during routine practice, not as a part of the study. Participants may choose to enroll in the study at any time after their doctor has prescribed damoctocog alfa pegol to prevent bleeding episodes.

The main purpose of this study is to learn more about how a treatment with damoctocog alfa pegol works to prevent bleeding episodes in routine medical practice. To answer this question, doctors will collect:

* information about bleeding episodes including the type and the location of the bleed * information about the treatment with damoctocog alfa pegol and other FVIII products * the overall health status of the participants

Data will be collected from participants over two years after they enroll in the study or until they choose to leave the study or switch to another hemophilia A treatment. Historical data will come from the participants' medical records or by interviewing the patient and parent/ legal guardian. The children's parents/ guardians will be asked to maintain a health diary to record details of bleeding episodes and treatment with damoctocog alfa pegol. The children's parents/ guardians will also be asked to answer a questionnaire (PedHAL) to assess the effect of hemophilia on their child's functional and physical activities.

In this study, only available data from routine care will be collected. No additional visits or tests are required as part of this study.

A vizsgálat 2 csoportja

  • Previously treated patients (PTPs) with hemophilia A

    Previously treated patients with hemophilia A who have been prescribed damoctocog alfa pegol for regular continuous prophylaxis.

    Kezelés: Damoctocog alfa pegol (Jivi, Bay94-9027)

  • Previously untreated or minimally treated patients (PUPs/MTPs) with hemophilia A

    Patients previously not treated with FVIII (previously untreated patients (PUPs)), or minimally treated (≤4 exposure days (MTPs)).

    Kezelés: Damoctocog alfa pegol (Jivi, Bay94-9027)

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

Contact the study team: see the registry record → Contacts and Locations

Oldal nyomtatása az orvosomnak

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
An Observational Study Describing Real-World Treatment Outcomes of Damoctocog Alfa Pegol in Patients Aged 7 to <12 Years With Hemophilia A
Illeszkedési kérdések
Forrás: NCT07088458: ki vehet részt
A regiszteradat frissítve
2026. november 13.