An Open-label Extension Trial to Evaluate the Long-term Safety of KVD900 (Sebetralstat) for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients With Hereditary Angioedema (HAE)
This study is an extension of a previous clinical trial for KVD900 (Sebetralstat), a medication designed to treat sudden swelling attacks in people with Hereditary Angioedema (HAE). It's an 'open-label' study, meaning everyone involved knows they are taking KVD900. Researchers want to understand the long-term safety of KVD900 when used by teenagers and adults aged 12 and over. Participants will continue to take KVD900, either 300 mg or 600 mg, to treat their HAE attacks as they happen. The study aims to gather important information on how safe the medication is over an extended period. This is crucial for ensuring that KVD900 can be a safe and effective treatment option for those living with HAE.
At a glance
What is this study about?
This study is about getting more information on a medication called KVD900 (also known as Sebetralstat), which is being developed to treat sudden attacks of swelling in people with a condition called Hereditary Angioedema (HAE). HAE is a rare genetic disorder that can cause unpredictable and painful swelling in various parts of the body.
This particular trial is an 'extension study', which means it's for people who have already taken part in a previous study of KVD900. The main goal here is to carefully observe and understand the long-term safety of the medication. When new medicines are tested, it's really important to see how they affect people over longer periods, not just for a few weeks or months. This helps doctors and regulators make sure the medicine is safe and well-tolerated when used regularly.
Participants in this study, which includes teenagers and adults aged 12 and older, will continue to take KVD900 to treat their HAE attacks as they occur. By gathering more data on its use over time, researchers can build a complete picture of KVD900's safety profile. This knowledge is essential for hopefully making KVD900 a widely available and safe treatment option for people living with HAE.
Key takeaways
- This study is for people who have already been part of a KVD900 trial.
- It aims to understand the long-term safety of KVD900 for HAE attacks.
- Participants will continue taking KVD900 tablets (300mg or 600mg) for their attacks.
- The study includes teenagers and adults aged 12 and older with HAE Type I or II.
- Regular clinic visits and recording information in an e-diary will be required.
- Your health will be closely monitored by a dedicated study team.
Who may be eligible?
To join this study, you must have already participated in the KVD900-301 clinical trial. You need to have a confirmed diagnosis of Hereditary Angioedema (HAE) type I or II and have experienced at least two HAE attacks in the three months before joining this particular study.
Participants must be at least 12 years old. If you're currently taking other long-term medicines for HAE, your dosage needs to have been stable for at least three months (or six months if you're taking danazol). You should be able to swallow tablets whole and manage using an electronic diary.
You would not be able to join if you left the previous KVD900-301 study due to not following the rules, withdrawing your consent, or safety concerns. Also, if you have other types of angioedema (like acquired C1 inhibitor deficiency or HAE with normal C1-INH), have had a poor response to certain HAE treatments in the past, or are taking specific other medications (like attenuated androgens other than danazol), you would not be eligible.
- Have you already taken part in the KVD900-301 study?
- Do you have a confirmed diagnosis of HAE Type I or II?
- Have you had at least two HAE attacks in the past three months?
- Are you 12 years old or older?
- Are you able to swallow tablets whole?
- Are you willing and able to use an electronic diary?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you join this study, you will continue to take KVD900 tablets (either 300 mg or 600 mg) to treat your HAE attacks as they happen. This study is designed to observe you over a longer period, so there isn't a fixed total duration mentioned, it will continue as long as necessary to gather long-term safety data. You will be asked to accurately record your HAE attacks and medication use in an electronic diary. You will have regular visits to the study clinic, where the study team will monitor your health, check for any side effects, and make sure the medication is working well for you. All study medications and assessments will be provided at no cost.
Potential risks and benefits
Locations (71)
- KalVista Investigative SiteScottsdale, United States
- KalVista Investigative SiteLittle Rock, United States
- KalVista Investigative SiteSan Diego, United States
- KalVista Investigative SiteSan Diego, United States
- KalVista Investigative SiteSanta Monica, United States
- KalVista Investigative SiteCentennial, United States
- KalVista Investigative SiteColorado Springs, United States
- KalVista Investigative SiteEvansville, United States
- KalVista Investigative SiteOverland Park, United States
- KalVista Investigative SiteLouisville, United States
- KalVista Investigative SiteChevy Chase, United States
- KalVista Investigative SitePlymouth, United States
+59 more sites — see the official record for the full list.
Common questions
What is Hereditary Angioedema (HAE)?
HAE is a rare genetic condition that causes sudden, unpredictable, and often painful swelling attacks in various parts of the body, such as the face, hands, feet, belly, or throat.
What is KVD900 (Sebetralstat)?
KVD900 is a new medication being studied to treat HAE attacks when they happen. It's taken by mouth as a tablet.
What does 'open-label' mean?
Open-label means that everyone involved in the study – both the participants and the study team – knows that everyone is receiving the study medication, KVD900.
Will I get paid to participate?
The information provided doesn't mention payment, but often travel costs to the clinic visits can be reimbursed. It's best to ask the study team directly about this.
What happens if I decide to leave the study early?
You are free to leave the study at any time, for any reason, without needing to explain why. Your decision will not affect your standard medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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