Extension Study of Infigratinib in Children With Achondroplasia (ACH)

This study is for children and teenagers with achondroplasia, generally between the ages of 3 and 18. Some participants will have already taken Infigratinib in a previous study and are continuing with it. Others may be new to the medicine, but they must have had their growth carefully monitored for at least six months in another study beforehand.

To join, participants and their parents or guardians must be able to attend study visits and follow the instructions. The child must also be able to swallow tablets. For girls aged 10 or older, or those who have started their periods, a negative pregnancy test is needed. If sexually active, effective contraception must be used during and for one month after the study.

Children cannot join if they have another health condition that might interfere with the study or make participation unsafe. They also can't be in another clinical study not sponsored by QED. Those who have already reached their full adult height are not eligible to join.

If you or your child decides to take part in this study, you'll have regular visits to the clinic. These visits will involve health checks, blood tests, and other assessments to see how the medicine is affecting growth and overall health. The medication, Infigratinib, will be taken as tablets.

Throughout the study, doctors will closely monitor for any side effects and check how well the medicine is working. Part of the study also involves assessing your child's quality of life, which means asking questions about how they feel and their daily activities. The total duration of participation will be discussed with you, as this is an extension study and participants may continue for a longer period.