AR101 Real-World Open-Label Extension Study
Status: | Active, not recruiting |
---|---|
Conditions: | Allergy, Allergy, Neurology |
Therapuetic Areas: | Neurology, Otolaryngology |
Healthy: | No |
Age Range: | 4 - 18 |
Updated: | 12/22/2018 |
Start Date: | October 19, 2017 |
End Date: | April 2019 |
Real-World AR101 Market-Supporting Experience Study in Peanut-Allergic Children, Active Treatment Arm Open-Label Extension Study (RAMSES OLE)
This study is enrolling participants by invitation only. This is an open-label, safety
extension study for subjects who participated in the ARC007 study.
extension study for subjects who participated in the ARC007 study.
This is a Phase 3, multi-center, North American, open-label, long-term, safety extension
study for eligible subjects who received AR101 therapy in the ARC007 trial and completed the
study.
study for eligible subjects who received AR101 therapy in the ARC007 trial and completed the
study.
Key Inclusion Criteria:
- Received AR101 in study ARC007
- Completed the ARC007 study
- Use of effective birth control by sexually active female subjects of childbearing
potential
Key Exclusion Criteria:
- Developed a clinically significant change in health status during the ARC007 study
which in the opinion of the investigator would make the subject unsuitable for
participation in this study.
- Receiving a prohibited medication or anticipated use of a prohibited medication [e.g.,
angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers or calcium
channel blockers], any monoclonal antibody, any investigational peanut immunotherapy,
or any other immunomodulatory therapy.
- Currently in the build-up phase of immunotherapy for any nonfood allergen.
- Currently participating in any other interventional clinical study outside of the
ARC007 study that was just completed.
We found this trial at
59
sites
Chapel Hill, North Carolina 27599
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
1-513-636-4200
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
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Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
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225 E Chicago Ave
Chicago, Illinois 60611
Chicago, Illinois 60611
(312) 227-4000
Ann & Robert H. Lurie Children's Hospital of Chicago Ann & Robert H. Lurie Children
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National Jewish Health National Jewish Health is known worldwide for treatment of patients with respiratory,...
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Arkansas Children's Hospital Arkansas Children's Hospital (ACH) is the only pediatric medical center in Arkansas...
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4650 Sunset Boulevard
Los Angeles, California 90027
Los Angeles, California 90027
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Mountain View, California 94040
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1975 4th Street
San Francisco, California 95148
San Francisco, California 95148
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Virginia Mason Medical Center Established in 1920, Virginia Mason began as an 80-bed hospital with...
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Tampa, Florida 33613
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111 Michigan Ave NW
Washington, District of Columbia
Washington, District of Columbia
(202) 476-5000
Childrens National Medical Center As the nation’s children’s hospital, the mission of Children’s National Medical...
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