A Phase 1 Placebo-Controlled Double-Blind Multicenter Study to Evaluate the Safety Tolerability Pharmacokinetics and Pharmacodynamics of a Single Dose of DCR-PHXC in Patients with Primary Hyperoxaluria Type 3

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Primary Hyperoxaluria Type 3
  • Age: Between 6 - 80 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Participants(and/or participant’s parent or legal guardian) must provide written informed consent before any study assessments are performed
    2. Those wtih documented diagnosis of primary hyperoxaluria type 3 (PH3), confirmed by genotyping
    3. History of at least one stone event within the last 12 months. Stone events are defined as any of the following:
      • Renal stone requiring medical intervention
      • Stone passage with or without hematuria
      • Renal colic requiring medication
    4. Male participants with a female partner of childbearing potential must agree to use contraception. Female participants who are not pregnant or breastfeeding. Both must use contraceptive methods as per the protocol

You may not be eligible for this study if the following are true:

    1. Prior renal or hepatic transplantation; or planned transplantation within the study period
    2. Currently receiving dialysis or anticipating requirement for dialysis
    3. Documented evidence of clinical manifestations of systemic oxalosis
    4. Presence of any condition or comorbidities that would interfere with study compliance or data interpretation or potentially impact patient safety
    5. Liver function test abnormalities
    6. Positive screening for hepatitis B surface antigen (HBsAg), anti-hepatitis C virus (HCV) antibodies, or anti-human immunodeficiency virus (HIV) 1 and 2 antibodies.
    7. Participation in any clinical study in which they received an investigational medicinal product (IMP)

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