1. Signed written informed consent by patient or patient’s legally authorized representative.
2. Be at least 18 years of age.
3. Have Chronic Liver Disease, a score of >11 on the 12-item Pruritus Severity Scale at screening, has intractable pruritus and is seeking alternative therapy for it, beyond their SMT, for one of the following reasons:
   a. failed at least 4 weeks of prescribed Standard Medical Therapy (SMT). Failure is defined as tolerance to prescribed SMT, but unresponsive to it. Unresponsive is defined as the patient continuing to complain of significant pruritus after receiving at least 4 weeks of the prescribed SMT prior to screening OR
   b. are intolerant to prescribed SMT. Intolerance is defined as the patient experiencing side effects that led him/her to discontinue the prescribed SMT OR
   c. are unable to receive treatment due to lack of insurance approval.

Prescribed SMT for intractable pruritus is per the standard of care/practice of the patient’s treating provider.