An Interventional Study of Infigratinib in Children With Hypochondroplasia

To join this study, children must already be taking part in another related study (QBGJ398-004) and have completed at least 26 weeks. They also need to have hypochondroplasia, which has been confirmed by a doctor and a special test.

For the first part of the study, children need to be between 5 and 11 years old. For the second, larger part, children can be from 3 up to 18 years old and still have the potential to grow. It’s also important that they can swallow medicine by mouth and are able to stand and walk on their own.

There are also some things that would prevent a child from joining. For example, if they have another reason for being short other than hypochondroplasia, or if they have certain serious health problems, they wouldn't be able to take part. Also, if they've had specific eye problems or certain types of previous surgery, they might not be suitable.

If your child takes part in this study, they would receive a medicine called infigratinib, which is given by mouth. The study involves regular visits to the hospital or clinic. These visits will likely include growth measurements, general health checks, and possibly blood tests or eye exams to monitor how your child is doing and to check for any side effects.

The study will last for a period of time, and the research team will explain exactly how long your child would need to be involved and what each visit would entail. It's important that participants and their parents or guardians are able and willing to attend all scheduled appointments and follow the study instructions carefully. If your child is old enough to have periods, or if they are sexually active, there will be specific requirements about pregnancy tests and using contraception during and for a month after the study medicine.