Chiesi Farmaceutici S.p.A.: Angioedemas, Hereditary trials

The registry lists 12 Angioedemas, Hereditary studies with Chiesi Farmaceutici S.p.A. as lead sponsor. 2 are open to participants now and 3 have results posted.

Phase 1 3Phase 2 1Phase 3 4Phase 4 1No phase 3(a study in two phases counts in both)

Studies

Open to participants first, then studies with results posted, then the rest; newest registration first within each.

• Safety and Effectiveness of Sebetralstat (KVD900) for Short-Term Prophylaxis Before Procedures in People With Hereditary Angioedema (KONTROL)RecruitingNCT07654829Phase 4
• Treatment of Angioedema Attacks in Pediatric (Ages 2-11) Post-Trial and Naive Patients With HAE With SebetralstatAvailableNCT07216378
• Open-Label Safety, PK, and Efficacy Trial of Sebetralstat (KVD900) in Pediatric Patients (Ages 2-11) With HAE Type I or IICompletedNCT06467084Phase 3Results posted
• A Phase III, Crossover Trial Evaluating the Efficacy and Safety of KVD900 (Sebetralstat) for On-Demand Treatment of Angioedema Attacks in Adolescent and Adult Patients With Hereditary Angioedema (HAE)CompletedNCT05259917Phase 3Results posted
• A Phase II, Cross-over Clinical Trial Evaluating the Efficacy and Safety of KVD900 (Sebetralstat) in the On-demand Treatment of Angioedema Attacks in Adult Subjects With Hereditary Angioedema Type I or IICompletedNCT04208412Phase 2Results posted
• A Study Observing US Patients With HAE Type I or II Who Take Icatibant to Treat HAE AttacksCompletedNCT07009262
• Treatment of Angioedema Attacks in Adolescent and Adult Patients 12 Years and Older With HAE Type I or II With SebetralstatApproved for marketingNCT06628713
• PK Subtrial in Adolescent Patients With HAE Type I or II Participating in the KVD900-302 TrialCompletedNCT05511922Phase 3
• 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)CompletedNCT05505916Phase 3
• A Single and Multiple Doses Safety, Tolerability, Pharmacokinetics and Food Effect Study of KVD824 in Healthy VolunteersCompletedNCT05178355Phase 1
• Phase 1 Crossover Study in Healthy Subjects to Evaluate the PK Profile of KVD824 Following Single and Multiple Doses of Modified Release (MR) FormulationsCompletedNCT05118958Phase 1
• A Single Dose Safety, Tolerability, Pharmacokinetic and Food Effect Study of KVD900 (Sebetralstat) in Healthy VolunteersCompletedNCT04349800Phase 1