Long-term Safety Study of KVD900 for Treating Angioedema Attacks in Adolescents and Adults with Hereditary Angioedema Type I or II

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What is this study about?

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.

1 enrollment

The patient joins the study after providing signed informed consent. If applicable, a parent or legally authorized representative must also provide consent.

The patient must have a confirmed diagnosis of hereditary angioedema (HAE) type I or II and have experienced at least two documented HAE attacks within three months prior to enrollment.

The patient must be 12 years of age or older and able to swallow tablets whole.

2 treatment administration

The patient receives KVD900, an oral plasma kallikrein inhibitor, in the form of a film-coated tablet.

The medication is taken on-demand to treat angioedema attacks. The specific dosage and frequency are determined by the study protocol and the patient’s needs.

3 monitoring and assessment

The patient is monitored for any adverse events (AEs) and serious adverse events (SAEs) that may occur within two days of taking the medication.

Regular assessments are conducted to check for normal or abnormal laboratory results and vital signs at each scheduled visit.

4 symptom relief evaluation

The time to the beginning of symptom relief is evaluated, defined as at least ‘a little better’ within 12 hours of the initial dose.

The time to the resolution of the HAE attack is also assessed, defined as ‘none’ within 24 hours of the initial dose.

5 study duration

The study is estimated to continue until March 9, 2026.

The patient’s participation involves adhering to all protocol requirements and completing an electronic diary (eDiary) to document their experiences and any symptoms.

Who Can Join the Study?

  • Patients may continue from a previous study called KVD900-301.
  • Patient must provide signed informed consent, which means they agree to participate after understanding the study. If the patient is underage, a parent or legal representative must also sign.
  • Patient must have a confirmed diagnosis of Hereditary Angioedema (HAE) Type I or II, which is a genetic condition that can cause swelling.
  • Patient must have experienced at least 2 documented HAE attacks in the 3 months before joining the study.
  • If the patient is on long-term preventive treatment allowed by the study, they must have been on a stable dose for at least 3 months before joining.
  • Patient must be male or female and at least 12 years old.
  • Patient must meet the study’s contraception requirements to prevent pregnancy during the trial.
  • Patient must be able to swallow the trial tablets whole.
  • Patient must be able to properly receive and store the study medication, and be able to read, understand, and complete an electronic diary (eDiary).
  • The study doctor must believe that the patient is willing and able to follow all study requirements.

Who Cannot Join the Study?

  • Patients who do not have Hereditary Angioedema Type I or II cannot participate. This is a genetic condition that causes sudden swelling in different parts of the body.
  • Patients who are not in the age range specified for the study cannot participate. The study includes certain age groups, so if you are outside these groups, you cannot join.
  • Patients who are not willing or able to follow the study procedures cannot participate. This means if you cannot or do not want to follow the rules and steps of the study, you cannot be part of it.
  • Patients who are part of a vulnerable population that the study does not include cannot participate. Vulnerable populations might include groups like pregnant women or people with certain health conditions.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Univerzitna Nemocnica Martin Martin Slovakia
Semmelweis University Budapest Hungary
Azienda Ospedaliera di Padova Padua Italy
Diagnostic-consultative center “Aleksandrovska” EOOD Sofia Bulgaria
IRCCS Policlinico San Donato San Donato Milanese Italy
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie Cracow Poland
Hopital Beaujon Clichy France
Athens Naval Hospital Athens Greece
HZRM Haemophilie-Zentrum Rhein Main GmbH Mörfelden-Walldorf Germany
Centrul Clinic Mediquest S.R.L. Sangeorgiu De Mures Romania
Ljdrz Greegbo Htpkywyk Og Apgbyx Athens Greece
Aluhqsj Obdlxgjqnpf Oorjthgb Rulobjo Vzrpn Sinlg Cthhijwm Palermo Italy
Aldiznrim Ubc Amsterdam The Netherlands
Gwhrbj Ukrsakisuc Fonwluupi Frankfurt Germany
Fnwgqjfsn Pjqk Lb Ibrsfmaokpuyg Bpagbcbqp Dvy Hncdvsed Uvkthmslosvgi Lv Pfp Madrid Spain
Hmvglmxn Vdwk duvuuzvl Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
27.12.2022
Bulgaria Bulgaria
Not recruiting
27.12.2022
France France
Not recruiting
27.12.2022
Germany Germany
Not recruiting
27.12.2022
Greece Greece
Not recruiting
27.12.2022
Hungary Hungary
Not recruiting
27.12.2022
Italy Italy
Not recruiting
27.12.2022
Poland Poland
Not recruiting
27.12.2022
Portugal Portugal
Not recruiting
27.12.2022
Romania Romania
Not recruiting
27.12.2022
Slovakia Slovakia
Not recruiting
27.12.2022
Spain Spain
Not recruiting
27.12.2022
The Netherlands The Netherlands
Not recruiting
27.12.2022

Trial locations

Investigated drugs:

KVD900 is an oral medication being studied for its ability to treat angioedema attacks in patients with hereditary angioedema (HAE) type I or II. It works by inhibiting plasma kallikrein, an enzyme involved in the process that leads to swelling during an angioedema attack. This trial aims to evaluate the long-term safety of using KVD900 for on-demand treatment, meaning it is taken when an attack occurs, rather than on a regular schedule.

Hereditary Angioedema Type I or II – Hereditary Angioedema (HAE) is a genetic disorder characterized by recurrent episodes of severe swelling. This swelling can occur in various parts of the body, including the hands, feet, face, and airway, and can also affect the intestinal walls, leading to abdominal pain. Type I is the most common form and is caused by low levels of a protein called C1 inhibitor, while Type II is due to dysfunctional C1 inhibitor. These episodes of swelling can be triggered by stress, trauma, or even spontaneously without a clear cause. The condition is inherited in an autosomal dominant pattern, meaning a single copy of the altered gene in each cell is sufficient to cause the disorder. Symptoms typically begin in childhood or adolescence and can vary in frequency and severity among individuals.

Trial ID:
2023-505904-41-00
Protocol code:
KVD900-302
NCT ID:
NCT05505916
Trial Phase:
Therapeutic confirmatory (Phase III)

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