PK Subtrial in Adolescent Patients With HAE Type I or II Participating in the KVD900-302 Trial

Launched by KALVISTA PHARMACEUTICALS, LTD. · Aug 19, 2022

Keywords

ClinConnect Summary

This clinical trial, called the PK Subtrial, is studying how the body processes a medication called KVD900 in adolescents aged 12 to 17 who have Hereditary Angioedema (HAE) type I or II. HAE is a condition that causes sudden swelling in various parts of the body, which can be painful and dangerous. The trial aims to understand how KVD900 works in young patients who are already taking part in a larger study, known as KVD900-302, to help improve treatment options for HAE.

To be eligible for this trial, participants must be between 12 and 17 years old and currently involved in the KVD900-302 study. They will need to provide consent, meaning they agree to take part and understand what it involves, and a parent or guardian may also need to sign. Participants will be required to provide samples as part of the study, which includes filling out forms and keeping track of their health in an electronic diary. It's important to note that individuals with bleeding disorders or those taking certain blood-thinning medications cannot participate in this trial. Overall, participants can expect to contribute valuable information that may help improve future treatments for HAE in adolescents.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Male or female adolescent patient 12 to 17 years of age at the time of enrollment and during sample collection in this PK subtrial.
• • Patient is currently participating in KVD900-302.
• • Patient must provide signed informed consent or assent (when applicable), and a legally authorized representative (LAR) must also provide signed informed consent when applicable.
• • Patient and LAR are willing and able to provide samples per the requirements of the protocol, including willingness to complete forms and the electronic Diary, obtain and return samples in a timely manner, and obtain samples while within the required age limit.
• Exclusion Criteria:
• • Patient has a history of any bleeding disorder or currently taking any anti-coagulant or anti-platelet agent.