A Phase II, Cross-over Clinical Trial Evaluating the Efficacy and Safety of KVD900 (Sebetralstat)… (NCT04208412) | Clinical Trial Compass
CompletedPhase 2
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 II
United States84 participantsStarted 2019-07-02
Plain-language summary
This study is a randomized, double-blind, placebo-controlled, phase II, cross-over clinical trial evaluating the efficacy and safety of KVD900, in the treatment of hereditary angioedema attacks in adult subjects.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female adult subjects 18 years of age and older.
* Confirmed diagnosis of HAE type I or II at anytime in the medical history
* At least 3 documented HAE attacks in the past 93 days, as supported by medical history.
* Access to and ability to use conventional attack treatment for attacks of HAE
* Adequate organ functions
* Females of childbearing potential must agree to use highly effective birth control from the Screening visit until the end of the trial follow-up procedures.
* Females of non-childbearing potential, defined as surgically sterile (status post hysterectomy, bilateral oophorectomy, or bilateral tubal ligation) or post-menopausal for at least 12 months, do not require contraception during the study
* Males with female partners of childbearing potential must agree to be abstinent or else use a highly effective method of birth control as defined in inclusion 6 from the Screening visit until the end of the trial follow-up procedures
* Provide signed informed consent and are willing and capable of complying with study requirements and procedures
Exclusion Criteria:
* Any concomitant diagnosis of another form of chronic angioedema, such as acquired C1 inhibitor (C1-INH) deficiency, HAE with normal C1-INH (also known as HAE type III), idiopathic angioedema, or angioedema associated with urticaria
* Current use of C1INH, androgens, or tranexamic acid for HAE prophylaxis
* Use of angiotensin-converting enzyme (ACE) inhibitors or any estro…
What they're measuring
1
Time to Conventional Attack Treatment Use Within 12 Hours of Study Drug (Full Analysis Set)