Phase 3 Haemophilia Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

For Arms 1 and 2 (existing study participants transferring into this trial):

• People who have given their consent to participate before any study-related activities begin.
• People who have been diagnosed with haemophilia A from birth, as confirmed by medical records.
• People who are currently taking part in one of four specific related studies (NN7769-4513, NN7769-4514, NN7769-4516, or NN7769-4728), and who either completed at least 12 weeks in the extension part of study NN7769-4513, or have completed the final treatment visit in one of the other three studies.
• People (and/or their parent or legal representative) who are willing and able to attend scheduled visits, follow study procedures, and keep a study diary.

For Arm 3 (infants newly joining the trial):

• People who have given their consent before any study-related activities begin.
• Male or female infants diagnosed with severe haemophilia A from birth, with or without inhibitors to the clotting factor FVIII, as confirmed by medical records.
• Infants who are under 1 year of age at the time consent is signed.
• Infants who weigh at least 3.2 kilograms at the time consent is signed.
• Infants who have either never been treated for haemophilia, or who have had no more than 5 days of exposure to haemophilia-related treatments such as clotting factor products, plasma, or blood products.
• Infants who were born after a full-term pregnancy of at least 37 weeks.
• A parent or legal representative who is willing and able to attend visits, follow study procedures, keep a study diary, and complete questionnaires about the infant's health.
• Infants under 3 months of age must show no signs of bleeding in the brain at the screening stage, confirmed by an ultrasound scan of the head.
• Infants who have received vitamin K as a preventive measure, in line with local standard practice.
• Infants whose medical records include results for certain blood clotting tests (aPTT and FVIII levels).
• Infants whose medical records include, or for whom pre-study blood samples can be taken for, certain additional blood tests (fibrinogen, blood count, and liver and kidney markers).

Who may not be able to join:

For Arms 1 and 2:

• People who have any medical condition (other than those related to haemophilia A) that the study doctor believes could put them at risk or affect their ability to follow the study requirements.
• People who have already left or been withdrawn from any of the four related studies listed above.
• People who have previously participated in this current study (defined as having already signed a consent form for it).
• People who are pregnant, breastfeeding, or planning to become pregnant.
• Females of childbearing age who are not using a highly effective method of contraception, as required by the study or local guidelines.
• People currently participating in another clinical trial involving an investigational medicine (other than the four related studies listed above).
• People who have a major surgical procedure planned during Part 1 of the study.
• People who are unable or unwilling to cooperate, or who face a language barrier that would prevent them from understanding and following the study requirements.

For Arm 3:

• Infants with a known or suspected allergic reaction to the study treatment or related products.
• Infants who have previously participated in this study (defined as a consent form having already been signed for them).
• Infants who are currently participating in another clinical trial where the last dose of an investigational medicine was given within the past 6 months, or within 5 half-lives of that medicine, whichever is shorter.
• Infants who have received non-factor-based treatments to prevent bleeding within the past 6 months, or within 5 half-lives of that medicine, whichever is shorter.
• Infants with any other known blood clotting disorder, either inherited or acquired, beyond haemophilia A.
• Infants with other medical conditions or abnormal blood test results that the study doctor believes may increase the risk of bleeding or blood clots, or that could affect the infant's safety or ability to follow the study.
• Infants whose parent or legal representative is not able to accurately and promptly record treatment and bleeding episodes in a study diary.
• Infants who have previously been treated for, or who show signs of, blood clot-related conditions (with a limited exception for past catheter-related clots that are no longer being treated).
• Infants who have a major surgical procedure planned during Part 1 of Arm 3.
• Infants for whom immune tolerance induction therapy (a specific haemophilia treatment) is planned to start after the trial treatment begins.
• Infants with signs of significant liver problems, defined by specific elevations in liver-related blood test results (AST and/or ALT more than 3 times the upper limit of normal, combined with bilirubin more than 1.5 times the upper limit of normal).
• Infants with kidney function results above 1.5 times the upper limit of normal for creatinine levels in the blood.

Important: Always verify eligibility with the trial site directly before applying.