Hereditary angioedema with C1 esterase inhibitor deficiency – European Clinical Trials Information Network https://clinicaltrials.eu Bridging Patients with Clinical Trials Wed, 24 Jun 2026 04:15:41 +0000 en-US hourly 1 https://wordpress.org/?v=7.0 https://clinicaltrials.eu/wp-content/uploads/2024/12/cropped-EU_icon-32x32.png Hereditary angioedema with C1 esterase inhibitor deficiency – European Clinical Trials Information Network https://clinicaltrials.eu 32 32 A study of navenibart for long-term safety in patients with hereditary angioedema https://clinicaltrials.eu/trial/a-study-of-navenibart-for-long-term-safety-in-patients-with-hereditary-angioedema/ Thu, 30 Apr 2026 13:08:42 +0000 https://clinicaltrials.eu/trial/a-study-of-navenibart-for-long-term-safety-in-patients-with-hereditary-angioedema/ This study involves Hereditary Angioedema, which is a rare inherited condition that causes episodes of swelling in different parts of the body, including the hands, feet, face, intestinal tract, and airways. These swelling episodes, called attacks, can be painful and potentially dangerous, especially when they affect the throat or abdomen. The treatment being tested is called Navenibart, also known by its code name STAR-0215. This medication is designed to work against a specific protein in the blood called plasma kallikrein, which plays a role in causing the swelling attacks. Some participants will receive Navenibart while others will receive placebo. The medication is given as an injection under the skin.

The purpose of this study is to assess the long-term safety and tolerability of Navenibart in people with Hereditary Angioedema. The study will also look at how well the medication works in preventing swelling attacks over an extended period of time. Participants in this study will be people who previously took part in another study called STAR-0215-301 and either completed that study or received at least two doses of the medication and were followed for at least two months after the second dose.

During the study, participants will receive regular doses of the medication, with a maximum daily dose of 600 milligrams and a total maximum dose of 9600 milligrams over a treatment period of up to 48 weeks. The study will track any side effects or health problems that occur during treatment. Researchers will also count how many swelling attacks participants experience, including how many are moderate or severe, and how many require emergency treatment. The study will measure whether participants have fewer attacks compared to before treatment, including whether they achieve reductions of 50 percent, 70 percent, or 90 percent in their attack rate, or whether they have no attacks at all. Quality of life will be measured using a questionnaire specifically designed for people with swelling conditions.

]]> Study of Navenibart to prevent attacks in adults and adolescents with Hereditary Angioedema https://clinicaltrials.eu/trial/study-of-navenibart-to-prevent-attacks-in-adults-and-adolescents-with-hereditary-angioedema/ Wed, 29 Apr 2026 15:07:29 +0000 https://clinicaltrials.eu/trial/study-of-navenibart-to-prevent-attacks-in-adults-and-adolescents-with-hereditary-angioedema/ This study focuses on people with Hereditary Angioedema (HAE), a rare genetic condition that causes unexpected episodes of severe swelling in various parts of the body. The research evaluates a new medication called Navenibart (also known as STAR-0215), which is being tested to see if it can prevent HAE attacks from occurring.

The study compares Navenibart against placebo to determine how effective it is in reducing the frequency of HAE attacks. During the study, participants will receive either Navenibart or placebo as a subcutaneous (under the skin) injection. The treatment period lasts for 6 months, during which participants will be monitored for any HAE attacks and their severity.

Throughout the study, researchers will track how many HAE attacks occur and how severe they are. They will also monitor the overall well-being of participants and any changes in their quality of life. The medication will be tested in both adults and adolescents with HAE to evaluate its safety and effectiveness in preventing attacks.

]]> Study on the Safety and Effects of Sebetralstat for Children Aged 2-11 with Hereditary Angioedema Type I or II https://clinicaltrials.eu/trial/study-on-the-safety-and-effects-of-sebetralstat-for-children-aged-2-11-with-hereditary-angioedema-type-i-or-ii/ Wed, 29 Apr 2026 15:00:15 +0000 https://clinicaltrials.eu/trial/study-on-the-safety-and-effects-of-sebetralstat-for-children-aged-2-11-with-hereditary-angioedema-type-i-or-ii/ This clinical trial is focused on studying a condition called Hereditary Angioedema (HAE), specifically types I and II, in children aged 2 to 11 years. HAE is a rare genetic disorder that causes sudden swelling in various parts of the body, such as the face, hands, and feet. The trial will use a medication known as sebetralstat, which is also referred to by its code name KVD900. This medication is taken orally as an orodispersible tablet, meaning it dissolves in the mouth without the need for water.

The purpose of the study is to evaluate the safety and tolerability of sebetralstat in young patients with HAE. Participants in the study will receive the medication and be monitored over a period of up to 12 weeks. During this time, researchers will observe any side effects and how well the medication is tolerated by the children. The study will also look at how quickly symptoms improve after taking the medication and how long it takes for an HAE attack to resolve.

Some participants may receive a placebo, which is a substance with no active medication, to help compare the effects of sebetralstat. The trial aims to gather important information that could help in understanding how this medication works in children with HAE and potentially improve treatment options for this condition in the future.

]]> Study on the Long-Term Safety of STAR-0215 for Adults with Hereditary Angioedema https://clinicaltrials.eu/trial/study-on-the-long-term-safety-of-star-0215-for-adults-with-hereditary-angioedema/ Wed, 29 Apr 2026 14:57:45 +0000 https://clinicaltrials.eu/trial/study-on-the-long-term-safety-of-star-0215-for-adults-with-hereditary-angioedema/ This clinical trial is focused on studying hereditary angioedema, a rare genetic condition that causes sudden swelling in various parts of the body, such as the face, hands, and feet. The study will use a treatment called STAR-0215, which is administered as a sterile solution through subcutaneous use, meaning it is injected under the skin. The purpose of the study is to assess the long-term safety and tolerability of this treatment in adults with hereditary angioedema.

Participants in the trial will receive repeat doses of STAR-0215 over a period of time. The study will monitor the occurrence of any adverse events, which are unexpected medical problems that may happen during the trial. Additionally, the study will observe changes in the frequency and severity of hereditary angioedema attacks, as well as the duration of these attacks. The trial will also look at how long it takes for an attack to occur after each dose and the number of days participants remain free from attacks.

Throughout the study, researchers will measure the concentration of STAR-0215 in the body and any changes in plasma kallikrein activity, which is a protein involved in the swelling process. The formation of antibodies against the drug will also be monitored. This trial aims to provide valuable information on the effectiveness and safety of STAR-0215 for individuals living with hereditary angioedema.

]]> Study on C1 Esterase Inhibitor for Treating and Preventing Hereditary Angioedema Attacks in Patients with C1-INH Deficiency https://clinicaltrials.eu/trial/study-on-c1-esterase-inhibitor-for-treating-and-preventing-hereditary-angioedema-attacks-in-patients-with-c1-inh-deficiency/ Wed, 29 Apr 2026 14:57:24 +0000 https://clinicaltrials.eu/trial/study-on-c1-esterase-inhibitor-for-treating-and-preventing-hereditary-angioedema-attacks-in-patients-with-c1-inh-deficiency/ This clinical trial is focused on studying a condition known as hereditary angioedema, which is a rare genetic disorder that causes sudden swelling in various parts of the body, such as the face, hands, and feet. The study is testing a treatment called C1-esterase inhibitor, which is derived from human plasma and is designed to help prevent and treat these swelling attacks. The treatment is given through an intravenous injection, meaning it is administered directly into a vein.

The purpose of the study is to determine if the C1-esterase inhibitor is more effective than a placebo in relieving the symptoms of an acute attack in people with hereditary angioedema. Participants in the study will receive either the treatment or a placebo, and neither the participants nor the researchers will know which one is being administered, a method known as a double-blind study. The study will monitor how quickly participants experience relief from their symptoms after receiving the injection.

Participants will be involved in the study for a period of time during which they will receive the treatment or placebo and be observed for any changes in their condition. The study aims to provide valuable information on the safety and effectiveness of the C1-esterase inhibitor in managing hereditary angioedema attacks, potentially leading to improved treatment options for those affected by this condition.

]]> Long-term Safety Study of KVD900 for Treating Angioedema Attacks in Adolescents and Adults with Hereditary Angioedema Type I or II https://clinicaltrials.eu/trial/long-term-safety-study-of-kvd900-for-treating-angioedema-attacks-in-adolescents-and-adults-with-hereditary-angioedema-type-i-or-ii/ Wed, 29 Apr 2026 14:56:44 +0000 https://clinicaltrials.eu/trial/long-term-safety-study-of-kvd900-for-treating-angioedema-attacks-in-adolescents-and-adults-with-hereditary-angioedema-type-i-or-ii/ This clinical trial is focused on studying the long-term safety of a medication called KVD900 for treating attacks in patients with Hereditary Angioedema (HAE) Type I or II. Hereditary Angioedema is a rare genetic condition that causes sudden swelling in various parts of the body, such as the face, hands, and feet. The medication being tested, KVD900, is taken as a film-coated tablet and works as an oral plasma kallikrein inhibitor, which means it helps to prevent the swelling attacks by blocking a specific protein in the blood.

The purpose of this study is to evaluate if KVD900 is safe and effective for long-term use in adolescents and adults who experience these swelling attacks. Participants in the study will take KVD900 as needed when they feel an attack coming on. The study will monitor the safety of the medication over time by checking for any side effects and observing how well the medication works in reducing the symptoms of the attacks.

Throughout the study, participants will have regular check-ups to assess their health and the effects of the medication. This includes monitoring any changes in their condition and ensuring that the medication is working as intended. The study aims to provide valuable information on the long-term use of KVD900 for managing Hereditary Angioedema attacks, helping to improve treatment options for those affected by this condition.

]]> Study on Oral PHA-022121 for Preventing Angioedema Attacks in Patients with Hereditary Angioedema https://clinicaltrials.eu/trial/study-on-oral-pha-022121-for-preventing-angioedema-attacks-in-patients-with-hereditary-angioedema/ Wed, 29 Apr 2026 14:47:38 +0000 https://clinicaltrials.eu/trial/study-on-oral-pha-022121-for-preventing-angioedema-attacks-in-patients-with-hereditary-angioedema/ This clinical trial is focused on studying a condition known as hereditary angioedema (HAE), which is a rare genetic disorder that causes sudden swelling in various parts of the body, such as the face, hands, and feet. The swelling is due to a deficiency in a protein called C1-Inhibitor. The study is testing a new treatment called PHA-022121, which is taken as a soft capsule by mouth. This medication is designed to prevent the swelling attacks associated with HAE by blocking a specific receptor in the body known as the bradykinin B2 receptor.

The purpose of the study is to evaluate the safety and effectiveness of PHA-022121 in preventing HAE attacks. Participants in the study will be randomly assigned to receive either the new medication or a placebo, which looks like the medication but does not contain the active ingredient. The study is conducted in two parts. In the first part, different doses of the medication will be tested to find the most effective dose. In the second part, the long-term safety of the medication will be assessed. Participants will take the medication over a period of time and will be monitored for any changes in the frequency and severity of their HAE attacks.

Throughout the study, participants will have regular check-ups to ensure their safety and to track the effectiveness of the treatment. The study aims to provide valuable information on whether PHA-022121 can be a safe and effective option for people with hereditary angioedema, potentially offering a new way to manage this challenging condition.

]]> Study on Deucrictibant and Icatibant for Treating Hereditary Angioedema Attacks in Adolescents and Adults https://clinicaltrials.eu/trial/study-on-deucrictibant-and-icatibant-for-treating-hereditary-angioedema-attacks-in-adolescents-and-adults/ Wed, 29 Apr 2026 14:27:15 +0000 https://clinicaltrials.eu/trial/study-on-deucrictibant-and-icatibant-for-treating-hereditary-angioedema-attacks-in-adolescents-and-adults/ This clinical trial is focused on studying a condition known as Hereditary Angioedema, which is a rare genetic disorder that causes sudden swelling in various parts of the body, such as the face, hands, and feet. The study is testing a new treatment called Deucrictibant (PHA-022121), which is taken as a soft capsule by mouth. The purpose of the study is to see how effective Deucrictibant is in providing relief from the symptoms of Hereditary Angioedema attacks compared to a placebo.

Participants in the study will be randomly assigned to receive either the Deucrictibant capsule or a placebo during different periods of the study. This is known as a crossover study, meaning that each participant will have the chance to receive both the actual medication and the placebo at different times. The study will last for a period of up to 42 days, during which participants will take the medication as needed when they experience an attack. The researchers will monitor how quickly and effectively the medication provides relief from symptoms.

The study aims to gather information on how well Deucrictibant works in reducing the time it takes for symptoms to improve during an attack. This information will help determine if Deucrictibant can be a reliable on-demand treatment option for people with Hereditary Angioedema. Participants will be asked to record their symptoms and any changes they experience using an electronic diary, which will help the researchers assess the effectiveness of the treatment.

]]> Study on the Safety and Effects of STAR-0215 for Adults with Hereditary Angioedema https://clinicaltrials.eu/trial/study-on-the-safety-and-effects-of-star-0215-for-adults-with-hereditary-angioedema/ Wed, 29 Apr 2026 14:26:38 +0000 https://clinicaltrials.eu/trial/study-on-the-safety-and-effects-of-star-0215-for-adults-with-hereditary-angioedema/ This clinical trial is focused on studying a condition known as Hereditary Angioedema (HAE), which is a rare genetic disorder that causes sudden and severe swelling in various parts of the body. The study is investigating a new treatment called STAR-0215, which is administered as a sterile solution through a small injection under the skin, known as subcutaneous use. The main goal of the study is to evaluate the safety and tolerability of this treatment in adults with Type I or Type II HAE.

Participants in the trial will receive either a single dose or multiple doses of STAR-0215. Throughout the study, researchers will monitor participants for any side effects and changes in their health, such as vital signs and laboratory test results. The study will also look at how often HAE attacks occur, how severe they are, and how long they last. Additionally, the study will measure the levels of STAR-0215 in the blood and check for any immune response to the treatment.

The trial is expected to continue until October 2024, with recruitment having started in September 2023. This research aims to provide valuable information about the potential of STAR-0215 as a treatment option for people living with Hereditary Angioedema, potentially improving their quality of life by reducing the frequency and severity of swelling episodes.

]]> Study on the Safety of Long-Term Use of Deucrictibant for Treating Hereditary Angioedema Attacks in Patients with C1-Inhibitor Deficiency https://clinicaltrials.eu/trial/study-on-the-safety-of-long-term-use-of-deucrictibant-for-treating-hereditary-angioedema-attacks-in-patients-with-c1-inhibitor-deficiency/ Wed, 29 Apr 2026 14:26:01 +0000 https://clinicaltrials.eu/trial/study-on-the-safety-of-long-term-use-of-deucrictibant-for-treating-hereditary-angioedema-attacks-in-patients-with-c1-inhibitor-deficiency/ This clinical trial is focused on studying a condition known as Hereditary Angioedema, which is a rare genetic disorder that causes sudden swelling attacks in various parts of the body, including the face, hands, and throat. The study is specifically looking at patients with Hereditary Angioedema due to a deficiency in a protein called C1-Inhibitor, which can be of Type I or Type II. The treatment being tested is an oral medication called Deucrictibant (PHA-022121), which is designed to be taken during an acute attack to help manage the symptoms.

The purpose of this study is to evaluate the safety of long-term use of Deucrictibant for treating these acute attacks, including those affecting the throat, but without causing breathing difficulties. Participants in the study will take the medication as needed during an attack, and their health will be monitored over time to ensure the treatment is safe. The study will also involve a comparison with a placebo, which is a substance with no active medication, to better understand the effects of Deucrictibant.

Throughout the study, participants will be asked to report any side effects they experience, and regular health checks will be conducted, including monitoring vital signs and performing laboratory tests. The study aims to provide valuable information on how well Deucrictibant works in relieving symptoms and improving the quality of life for those with Hereditary Angioedema. This research is important for developing effective treatments for managing this challenging condition.

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