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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: A Phase 1 Study of DCR-PH1 in Patients With Primary Hyperoxaluria Type 1 (PH1)

Brief Summary: A phase 1 study of DCR-PH1 in patients with primary hyperoxaluria type 1 (PH1) to determine the safety, tolerability, pharmacokinetic (PK) and pharmacodynamics (PD) effects of DCR-PH1 administered via-intravenous infusion (IV)

Detailed Summary:
Sponsor: Dicerna Pharmaceuticals, Inc.

Current Primary Outcome: The safety of DCR-PH1 evaluated by the proportion of subjects that experience adverse events (AEs) [ Time Frame: Through Day 29 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Profile of pharmacokinetics (PK) of DCR-PH1 - Cmax [ Time Frame: Through Day 29 ]
  • Profile of pharmacokinetics (PK) of DCR-PH1 - tmax [ Time Frame: Through Day 29 ]
  • Profile of pharmacokinetics (PK) of DCR-PH1 - AUC [ Time Frame: Through Day 29 ]
  • Profile of pharmacokinetics (PK) of DCR-PH1 - t½ [ Time Frame: Through Day 29 ]
  • The effect of DCR-PH1 on plasma glycolate levels [ Time Frame: Through Day 29 ]
  • The effect of DCR-PH1 on urine glycolate levels [ Time Frame: Through Day 29 ]
  • The effect of DCR-PH1 on plasma oxalate levels [ Time Frame: Through Day 29 ]
  • The effect of DCR-PH1 on urine oxalate levels [ Time Frame: Through Day 29 ]


Original Secondary Outcome: Same as current

Information By: Dicerna Pharmaceuticals, Inc.

Dates:
Date Received: May 18, 2016
Date Started: May 2016
Date Completion: June 2017
Last Updated: October 11, 2016
Last Verified: October 2016