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HAE1

Phase 2

Allergic Asthma | Small molecule | Respiratory |Roche Holding AG|Last Updated: Jan 2, 2008

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment50

FDA Designations

No designations recorded

Clinical trial landscape

HAE1 · 1 trial · 1 indication

Phase 2 1
NCT00406965A Study to Evaluate the Safety and Efficacy of HAE1 in Subjects With Moderate to Severe Allergic AsthmaAllergic Asthma
COMPLETED50 Analytics
PHASE2COMPLETED
A Study to Evaluate the Safety and Efficacy of HAE1 in Subjects With Moderate to Severe Allergic Asthma
Allergic Asthma
NCT0040696550
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Study Endpoints

Primary Endpoints

The primary outcome measure is the change from baseline (Visit 1) in total asthma symptom score to Visit 10 (Day 140).

Secondary Endpoints

Incidence and severity of treatment-emergent adverse events and targeted adverse events and incidence of HAE-1 specific antibodies from Visit 1 to the end of the study
Change from baseline (Visit 1) in asthma symptom scores (nocturnal, morning, daytime, and total) at Visits 5, 6, 7, 8, and 10 (Days 28, 56, 84, 112, and 140)
Change from baseline (Visit 1) in the number of puffs per day of beta2-agonist rescue medication at Visits 5, 6, 7, 8, and 10 (Days 28, 56, 84, 112, and 140)
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Study Design & Arms

PurposeTREATMENT

Interventions

NameTypeDescription
HAE1 (PRO98498)DRUG -
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Eligibility Criteria

Age Range12 Years to 75 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Signed Informed Consent Form(s) * Male and females 12-75 years of age with the diagnosis of allergic asthma for 12 months according to the standards of the American Thoracic Society * Baseline FEV1 values ≥ 40% to ≤ 80% of the predicted normal value for the subject * Demonstra...

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Frequently asked questions about HAE1

What is HAE1 used for in allergic asthma?

HAE1 is an investigational small molecule being studied for the treatment of moderate to severe allergic asthma. It is intended for patients aged 12 years and older. The drug is currently in clinical development and has not been approved by regulatory authorities.

Who makes HAE1?

HAE1 is being developed by Roche Holding AG, a pharmaceutical company traded on the OTC market under the ticker RHHBY. The company is conducting clinical research to evaluate the safety and efficacy of HAE1 in patients with allergic asthma.

What phase is HAE1 in?

HAE1 is in Phase 2 clinical development. A Phase 2 study has been completed, but the drug remains investigational and is not yet approved for any use. Further clinical trials would be needed to establish its safety and efficacy.

What clinical trials is HAE1 in?

HAE1 has one completed clinical trial, identified as NCT00406965. This Phase 2 study evaluated the safety and efficacy of HAE1 in subjects with moderate to severe allergic asthma. The trial enrolled 50 participants and was not randomized or double-blinded.

Is HAE1 FDA approved?

No, HAE1 is not FDA approved. It is an investigational drug that has completed a Phase 2 clinical trial for allergic asthma. The drug is still in clinical development and has not received marketing authorization from regulatory agencies.