ClinicalTrials.Veeva

Menu

Open-Label Safety, PK, and Efficacy Trial of Sebetralstat (KVD900) in Pediatric Patients (Ages 2-11) With HAE Type I or II (KONFIDENT-KID)

KalVista Pharmaceuticals logo

KalVista Pharmaceuticals

Status and phase

Enrolling
Phase 3

Conditions

Hereditary Angioedema

Treatments

Drug: KVD900 300 mg
Drug: KVD900 150 mg
Drug: KVD900 75 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT06467084
KVD900-303

Details and patient eligibility

About

KVD900-303 is an open-label, multicenter clinical trial in patients aged 2 to 11 years old with HAE Type I or II.

Enrollment

24 estimated patients

Sex

All

Ages

2 to 11 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Male or female patients 2 to 11 years of age.
  2. Confirmed diagnosis of HAE Type I or II.
  3. Patient has had at least 1 documented HAE attack in the last year prior to screening.
  4. Caregiver, as assessed by the Investigator, must be able to appropriately store and administer IMP and be able to read, understand, and complete the diary.
  5. Investigator believes that the patient and caregiver are willing and able to adhere to all protocol requirements.
  6. Parent or Legally Authorized Representative (LAR) provides signed informed consent and patient provides assent (when applicable).

Exclusion criteria

  1. Any concomitant diagnosis of another form of chronic angioedema, such as acquired C1 inhibitor deficiency, HAE with normal C1-INH, idiopathic angioedema, or angioedema associated with urticaria.
  2. A clinically significant history of poor response to bradykinin receptor 2 blocker, C1-INH therapy, or plasma kallikrein inhibitor therapy for the management of HAE, in the opinion of the Investigator.
  3. Patient weighs <9.5 kg.
  4. Use of angiotensin-converting enzyme inhibitors after the Screening Visit.
  5. Any estrogen-containing medications with systemic absorption (such as oral contraceptives including ethinylestradiol or hormonal replacement therapy) within 7 days prior to the Screening Visit.
  6. Patients who require sustained use of strong cytochrome P450 3A4 (CYP3A4) inhibitors or inducers or moderate CYP3A4 inducers.
  7. Any clinically significant comorbidity or systemic dysfunction, which in the opinion of the Investigator, would jeopardize the safety of the patient by participating in the trial.
  8. Known hypersensitivity to sebetralstat or to any of the excipients.
  9. Participation in any interventional investigational clinical trial within 4 weeks of the last dosing of investigational drug prior to the Screening Visit.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

24 participants in 3 patient groups

75 mg Dose Group
Other group
Description:
Patients will take a single 75 mg dose of KVD900.
Treatment:
Drug: KVD900 75 mg
150 mg Dose Group
Other group
Description:
Patients will take a single 150 mg dose of KVD900 dose.
Treatment:
Drug: KVD900 150 mg
300 mg Dose Group
Other group
Description:
Patients will take a single 300 mg dose of KVD900.
Treatment:
Drug: KVD900 300 mg

Trial contacts and locations

6

Loading...

Central trial contact

KalVista Pharmaceuticals

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems