Overview

This trial is active, not recruiting.

Condition hereditary angioedema
Treatments dx-2930 - 300mg/2wk, dx-2930 - 300mg/4wk, dx-2930 150mg/4wk, placebo
Phase phase 3
Sponsor Shire
Collaborator Dyax Corp.
Start date November 2015
End date March 2017
Trial size 120 participants
Trial identifier NCT02586805, 2015-003943-20, DX-2930-03

Summary

This is a phase 3, multicenter, randomized, double-blind, placebo-controlled trial to evaluate the efficacy and safety of DX-2930 in preventing acute angioedema attacks in patients with Type I and Type II HAE.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
300 mg DX-2930 administered every 2 weeks by subcutaneous injection.
dx-2930 - 300mg/2wk
300 mg DX-2930 administered every 2 weeks by subcutaneous injection.
(Experimental)
300 mg DX-2930 administered every 4 weeks by subcutaneous injection
dx-2930 - 300mg/4wk
300 mg DX-2930 administered every 4 weeks by subcutaneous injection. To maintain the study blind, subjects will be given placebo injections every other 2 weeks when they are not receiving drug.
(Experimental)
150 mg DX-2930 administered every 4 weeks by subcutaneous injection
dx-2930 150mg/4wk
150 mg DX-2930 administered every 4 weeks by subcutaneous injection. To maintain the study blind, subjects will be given placebo injections every other 2 weeks when they are not receiving drug.
(Placebo Comparator)
Placebo administered every 2 weeks by subcutaneous injection.
placebo
Placebo administered every 2 weeks by subcutaneous injection.

Primary Outcomes

Measure
Number of Investigator confirmed HAE attacks per week observed in each DX-2930 treatment arm versus placebo arm
time frame: Efficacy assessment period (Day 0 through Day 182)

Secondary Outcomes

Measure
Number per week of HAE attacks requiring acute attack therapy use for each DX-2930 treatment arm versus placebo arm
time frame: Efficacy assessment period (Day 0 through Day 182)
Number per week of moderate or severe HAE attacks for each DX-2930 treatment arm versus placebo arm
time frame: Efficacy assessment period (Day 0 through Day 182)

Eligibility Criteria

Male or female participants at least 12 years old.

Inclusion Criteria: - Males and females 12 years of age or older at time of screening - Documented diagnosis of HAE, Type I or II - Baseline rate of at least 1 Investigator-confirmed HAE attack per 4 weeks - Adult subjects and caregivers of subjects under the age of 18 are willing and able to read, understand, and sign an informed consent form. Subjects age 12 to 17, whose caregiver provides informed consent, are willing and able to read, understand an dsign an assent form. - Males and femailes who are fertile and sexually active must adhere to contraception requirements. Exclusion Criteria: - Concomitant diagnosis of another form of chronic, recurrent angioedema, such as acquired angioedema, idiopathic angioedema, or recurrent angioedema associated with urticaria. - Participation in a prior DX-2930 study - Treatment with any other investigational drug or exposure to an investigational device within 4 weeks prior screening - Exposure to angiotensin-converting enzyme (ACE) inhibitors or any estrogen-containing medications within 4 weeks prior to screening. - Exposure to androgens within 2 weeks prior to entering the run-in period. - Use of long-term prophylactic therapy for HAE within 2 weeks prior to entering the run-in period. - Use of short-term prophylaxis for HAE within 7 days prior to entering the run-in period. - Any of the following liver function test abnormalities: alanine aminotransferase (ALT) > 3x upper limit of normal, or aspartate aminotransferase (AST) > 3x upper limit of normal, or total bilirubin > 2x upper limit of normal (unless the bilirubin elevation is a result of Gilbert's syndrome). - Pregnancy or breastfeeding.

Additional Information

Official title HELP Study: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study to Evaluate DX-2930 For Long-Term Prophylaxis Against Acute Attacks of Hereditary Angioedema (HAE)
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Shire.