Expanded access to bitopertin for EPP or XLP
Part of Digestive system, Genetic & congenital, Hormones & metabolism, Skin clinical trials.
This program provides access to an experimental drug called bitopertin, which may help reduce the severe light sensitivity and pain caused by EPP or XLP. It's for people aged 12 and older who have not had success with other treatments.
Summary written for real people, not researchers, by Clin2.
Who can take part
- You must be at least 12 years old.
- You need a confirmed diagnosis of EPP or XLP, which are rare conditions that cause severe pain and skin reactions after sun exposure.
- Your blood count (hemoglobin) must be at least 10 g/dL at the start.
- You should not have significant liver problems, such as elevated liver enzymes or a history of liver transplant.
- You must not be pregnant, planning pregnancy, or breastfeeding, and if you could become pregnant, you must agree to use contraception.
- You cannot be taking certain medications, including afamelanotide (Scenesse), strong CYP3A4 inhibitors or inducers, or opioids for more than 7 days.
Quick eligibility check
Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.
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