A Double-Blind, Multiple Ascending Dose Study to Assess Safety, Tolerability and Pharmacokinetics of DX-2930 in Hereditary Angioedema Participants

• Register: ClinicalTrials.gov
• Last refreshed on: 7 June 2021
• Main ID: NCT02093923
• Date of registration: 17/03/2014
• Prospective Registration: Yes
• Primary sponsor: Shire
• Public title: A Double-Blind, Multiple Ascending Dose Study to Assess Safety, Tolerability and Pharmacokinetics of DX-2930 in Hereditary Angioedema Participants
• Scientific title: A Phase 1b, Double-Blind, Multiple Ascending Dose Study to Assess Safety, Tolerability and Pharmacokinetics of DX-2930 in Hereditary Angioedema Subjects
• Date of first enrolment: May 14, 2014
• Target sample size: 38
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02093923
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1

Countries of recruitment

Italy, Jordan, United States

Contacts

• Name: Study Director
• Affiliation: Takeda

Key inclusion & exclusion criteria

Inclusion Criteria:

- At least 18 years of age at the time of screening

- Documented diagnosis of HAE (Type I or II)

- Experiencing =2 HAE attacks per year, with at least 1 attack in the past 6 months
reported by the participant

- Willing and able to read, understand, and sign an informed consent form

- Females of childbearing potential must agree to be abstinent or else use acceptable
forms of contraception throughout study

- Males with female partners of childbearing potential must agree to be abstinent or use
a medically acceptable form of contraception throughout study

Exclusion Criteria:

- Exposure to an investigational drug or device within 90 days prior to study

- History of exposure within the past 5 years to a monoclonal antibody or recombinant
protein bearing an Fc domain

- Concomitant diagnosis of another form of chronic angioedema

- Use of long-term prophylaxis for HAE within 90 days prior to study

- Use of C1-INH that exceeds a total of 30 days within the past 90 days prior to study;
any use of C1-INH within 7 days prior to study

- Exposure to angiotensin-converting enzyme (ACE) inhibitors or any estrogen-containing
medications with systemic absorption within 90 days prior to study

- Exposure to androgens within 90 days prior to study

- Presence of an indwelling catheter

- Diagnosis of HIV

- Active liver disease or liver function test abnormalities

- History of substance abuse or dependence

- Pregnancy or breastfeeding

- Any condition that, in the opinion of the Investigator, may compromise their safety or
compliance, preclude successful conduct of the study, or interfere with interpretation
of the results



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Hereditary Angioedema (HAE)

Intervention(s)

Drug: Placebo

Drug: DX-2930

Primary Outcome(s)

Number of Participants With Serious Adverse Events (SAE) and Treatment-Emergent Adverse Events (TEAE) [Time Frame: From Day 1 up to final follow-up (Day 123)]

Secondary Outcome(s)

Area Under the Plasma Concentration-Time Curve (AUC) [Time Frame: Days 1, 2, 4, 8, 15, 16, 18, 22, 29, 36, 50, 64, 92, and 120]

Apparent Clearance (CL/F) [Time Frame: Days 1, 2, 4, 8, 15, 16, 18, 22, 29, 36, 50, 64, 92, and 120]

Maximum Plasma Concentration (Cmax) [Time Frame: Days 1, 2, 4, 8, 15, 16, 18, 22, 29, 36, 50, 64, 92, and 120]

Terminal Elimination Half-Life (t1/2) [Time Frame: Days 1, 2, 4, 8, 15, 16, 18, 22, 29, 36, 50, 64, 92, and 120]

Time to Maximum Plasma Concentration (Tmax) [Time Frame: Days 1, 2, 4, 8, 15, 16, 18, 22, 29, 36, 50, 64, 92, and 120]

Apparent Volume of Distribution (Vd/F) [Time Frame: Days 1, 2, 4, 8, 15, 16, 18, 22, 29, 36, 50, 64, 92, and 120]

Secondary ID(s)

DX-2930-02

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 01/08/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02093923