A Study of DCR-PH1 in Patients With Primary Hyperoxaluria Type 1 (PH1)

Exclusion Criteria

• •Prior renal and/or hepatic transplantation
• •Participation in any clinical study involving administration of any investigational drug within the 30 days before enrollment
• •Pregnancy or lactation at the time of screening or enrollment
• •Women of child-bearing potential must have a negative pregnancy test, cannot be breastfeeding and must be willing to use contraception
• •Patients with a known history of human immunodeficiency virus (HIV) or active infection with hepatitis B virus or hepatitis C virus
• •Moderate to severe liver impairment
• •Liver function test abnormalities: alanine transaminases (ALT) and/or aspartate transaminases (AST) \> 2 times upper limit of normal (ULN)
• •History of severe reaction to a liposomal product or a known hypersensitivity to lipid products.
• •Unable to collect required study samples or follow study procedures
• •No clinically significant health concerns