A Trial to Evaluate the Efficacy and Safety of Different Doses of KVD824 for Prophylactic Treatme… (NCT05055258) | Clinical Trial Compass
TerminatedPhase 2
A Trial to Evaluate the Efficacy and Safety of Different Doses of KVD824 for Prophylactic Treatment of HAE Type I or II
Stopped: Terminated by Sponsor due to adverse events reported
United States33 participantsStarted 2021-11-18
Plain-language summary
A study to assess whether different doses of KVD824 are effective in preventing attacks of Hereditary Angiodedema Type I or Type II.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Male or female subjects 18 years of age and older.
✓. Confirmed diagnosis of HAE type I or II at any time in the medical history:
✓. Documented clinical history consistent with HAE (subcutaneous or mucosal, nonpruritic swelling episodes without accompanying urticaria) AND EITHER
✓. Diagnostic testing results obtained prior to randomization that confirm HAE Type I or II: C1-INH functional level \<40% of the normal level. Subjects with functional C1-INH level 40-50% of the normal level may be enrolled if they also have a C4 level below the normal range. Testing may be obtained from central or local laboratories or obtained from documented historical testing results. Subjects may be restested at anytime prior to randomization if results are incongruent with clinical history or believed by the Investigator to be confounded by recent prophylactic or therapeutic C1 INH use, OR
✓. Documented genetic results that confirm known mutations for HAE Type I or II.
✓. Subject has access to and ability to use conventional treatment for HAE attacks.
✓. Subject is willing to cease any current medications being taken for HAE prophylaxis and Investigator determines that doing so would not place the subject at any undue safety risk.
✓. Subject's last dose of attenuated androgens was at least 28 days prior to first dose of IMP.
Exclusion criteria
✕. Subjects who are not fertile or not sexually active, as defined below, do not require contraception.
What they're measuring
1
The Rate of Investigator-confirmed HAE Attacks During the Treatment Period
. Subjects who refrain from heterosexual intercourse during the trial if the reliability of the heterosexual abstinence has been evaluated in relation to the duration of the clinical trial and is the preferred and usual lifestyle of the subject.
✕. Male subjects who are surgically sterile (e.g. vasectomized with medical assessment of surgical success).
✕. Female subjects who are surgically sterile (e.g. status post hysterectomy, bilateral oophorectomy, or bilateral tubal ligation) or post menopausal for at least 12 months.
✕. Subjects must be able to swallow trial tablets whole.
✕0. Subjects assessed by the Investigator must be able to appropriately receive and store IMP, and be able to read, understand, and complete the eDiary.
✕1. Investigator believes that the subject is willing and able to adhere to all protocol requirements.
✕2. Subject provides signed informed consent and is willing and capable of complying with trial requirements and procedures.