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Clinical Trials/KCT0007136
KCT0007136Completed未知

Safety, efficacy and exposure of subcutaneously administered NNC0365-3769 (Mim8) prophylaxis in children with haemophilia A with or without FVIII inhibitors

ovo Nordisk0 sites8 target enrollmentStarted: TBDLast updated:
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Conditions

Trial Snapshot

Phase
未知
Status
Completed
Sponsor
Enrollment
8
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional Study

Eligibility Criteria

Ages
1(Year) to 12(Year) (—)
Sex
All

Inclusion Criteria

  • •1. Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
  • •2. Male and female participants with the diagnosis of congenital haemophilia A of any severity based on medical records.
  • •3. Aged 1-11 years (both inclusive) at the time of signing informed consent.
  • •4. For previously treated participants :
  • •a. Participant has been prescribed treatment with FVIII concentrate or bypassing agent in the last 26 weeks prior to screening.
  • •b. Participants with endogenous FVIII activity =1%, based on medical records, must have at least 1 treated bleed during the previous 26 weeks before screening for which factor VIII concentrate or bypassing agent has been prescribed (No requirements for participants with FVIII activity <1%).
  • •5. For previously untreated participants:
  • •a. Diagnosis of severe haemophilia A (endogenous FVIII activity < 1%) based on medical records.
  • •6. Child and parent/caregiver willingness and ability to comply with scheduled visits and study procedures, including the completion of diary and patient-reported outcomes questionnaires.a

Exclusion Criteria

  • •1. Known or suspected hypersensitivity to study product or related products.
  • •2. Previous participation in this study. Participation is defined as signed informed consent.
  • •3. Exposure to non-factor haemostatic products for bleeding prophylaxis within 6 months (or 5 half-lives of the medicinal product, whichever is shorter) prior to planned first dose, for participantsnot included in the run-in.
  • •4. Known congenital or acquired coagulation disorders other than haemophilia A.
  • •5. Other conditions (e.g. autoimmune disease) or laboratory abnormality that may increase risk of bleeding or thrombosis, as evaluated by the investigator.
  • •6. Any disorder, except for conditions associated with haemophilia A, that in the investigator’s opinion might jeopardise the participant’s safety or compliance with the protocol.
  • •7. Mental incapacity, unwillingness to cooperate or a language barrier precluding adequate understanding and cooperation.a
  • •8. Lack of adequate parental/caregiver support to enter accurately and timely information regarding treatment and bleeding episodes into an (electronic) diary.
  • •9. Previous or current treatment for thromboembolic disease (with the exception of previous catheter-associated thrombosis for which anti-thrombotic treatment is not currently ongoing) or signs of thromboembolic disease.
  • •10. Major surgery planned to take place after screening.
  • •11. Immune tolerance induction planned to take place after treatment initiation.
  • •12. Hepatic dysfunction defined as aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >3 times the upper limit of normal combined with total bilirubin >1.5 times the upper limit of normal measured at screening.
  • •13. Serum creatinine above 1.5 x upper limit of normal (ULN), measured at screening.
  • •14. Pregnancy (female participants).

Investigators

Sponsor
ovo Nordisk

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