Long Term Extension Trial of Setmelanotide

Más betegség

• Current, clinically significant disease
• Documented diagnosis of schizophrenia, bipolar disorder, personality disorder, major depressive disorder, or other psychiatric disorder(s)
• History of significant liver disease
• History or close family history of melanoma or participant history of oculocutaneous albinism
  • Other protocol defined Inclusion/Exclusion criteria may apply.

Laborértékek

• Moderate to severe renal dysfunction as defined by a glomerular filtration rate (GFR)<30 milliliters per minute (mL/min).

Egyéb

• Pregnant and/or breastfeeding women
• Significant dermatologic findings relating to melanoma or pre-melanoma skin lesions (excluding non-invasive basal or squamous cell lesion)
• Suicidal ideation, attempt or behavior

• Participants aged 2 or older (or aged >2 years as per local regulations) who had completed participation in a previous setmelanotide trial and demonstrated adequate safety and meaningful clinical benefit (efficacy)
• Participant and/or parent or guardian was able to communicate with the investigator, understand and sign the written informed consent/assent, and comply with the trial requirements
• Agree to use a highly effective form of contraception throughout the trial