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Search Results within category "Allergies"

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4 Study Matches

A multi-center, randomized, placebo-controlled, parallel-arm phase 2 study to investigate the efficacy, pharmakokinetics, and safety of CSL312 in subjects with Hereditary Angioedema.

This research is being done to see how safe a new investigational medication is to use and to see if the medication works to prevent HAE attacks. This study will also measure levels of drug in the blood to see how well it is tolerated.
Larisa Zifchak, RN at lzifchak@pennstatehealth.psu.edu or 717-531-4513
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03712228
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Inclusion Criteria:
18-65 (inclusive)
Clinical diagnosis of C1-INH Hereditary Angioedema
Clinical diagnosis of FXII/PLG Hereditary Angioedema
Willing to cease use of medication for routine prophylaxis against HAE attacks
Exclusion Criteria:
History of significant arterial or venous blood clotting
History of uncontrolled abnormal bleeding
Pre-planned surgeries
Known, incurable malignancies
Allergies
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Hershey, PA

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Two Dose Levels of BCX7353 as an Oral Treatment for the Prevention of Attacks in Subjects with Hereditary Angioedema

This study is for patients diagnosed with Type 1 or Type 2 Hereditary Angioedema (HAE) and have suffered HAE attacks (episodes of swelling), and are either not using HAE medications to prevent HAE attacks or for medical or personal choice reasons have decided to discontinue using these medications. This research is being done to compare the effects of two different doses of BCX7353 compared to placebo. Placebo-containing capsules look exactly like BCX7353 capsules, but do not contain BCX7353 or any other drug. The Sponsor will test two different doses of BCX7353 to see if BCX7353 is able to prevent or reduce the number of swelling episodes or attacks in people with HAE when taken every day by mouth, compared to placebo. This research study will also assess the safety of the new drug BCX7353.
Terri Smith at tjs97@psu.edu or 717-531-4513
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All
This study is NOT accepting healthy volunteers
NCT03485911
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Inclusion Criteria:
Adults & Children 12 years or older
Diagnoses with HAE Type 1 or Type 2
2 or more HAE attacks per month
Exclusion Criteria:
Pregnant females or planning on becoming pregnant or nursing
Anticipated use of short-term prophylaxis for pre-planned procedure or surgery
Chest pain, heart attack, passing out or significant heart beat abnormality
Pacemaker or defibrillator implanted
Family history of sudden cardiac death not related to HAE
Infectious Diseases & Immune System, Allergies
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Hershey, PA

AN OPEN-LABEL STUDY TO EVALUATE THE LONG-TERM SAFETY OF DAILY ORAL BCX7353 IN SUBJECTS WITH TYPE I AND II HEREDITARY ANGIOEDEMA

This is a clinical trial to determine the effectiveness of a daily oral medication in prevention of swelling attacks in patients with Hereditary Angioedema.
Joshua Adams at jadams4@pennstatehealth.psu.edu
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT03472040
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Inclusion Criteria:
Type I or II HAE
Used androgen therapy for prophylaxis of HAE episodes in past 12 months
Greater than or equal 40 kg
Access to appropriate rescue medication for HAE attacks
Exclusion Criteria:
Pregnant, breastfeeding, or planned pregnancy
Prior enrollment in BCX 7353 study
Known family history of sudden cardiac death
Infectious Diseases & Immune System, Allergies
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Hershey, PA

A randomized, double-blind, placebo-controlled, phase 2a study to assess the clinical efficacy of ISIS721744, a second-generation ligand-conjugated antisense inhibitor of prekallikrein, in patients with hereditary angioedema

This is a study to test whether an investigational drug given by injection every four weeks will reduce swelling episodes in patients with hereditary angioedema (HAE).
Joshua Adams at jadams4@pennstatehealth.psu.edu or 717-531-4513
All
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT04030598
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Inclusion Criteria:
Hereditary angioedema
18 years of age and above
able to use 1 acute medication to treat angioedema attacks
females non-pregnant and not planning to get pregnant
males must be using contraceptive method
Exclusion Criteria:
use of short-term prophylaxis for angioedema attacks
concurrent diagnosis of any othe type of recurrent angioedema
abnormalities in screening lab values
active infection
known history positive for HIV, hep C or B
Allergies
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Study Locations

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Location
Hershey, PA