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Study to Evaluate Safety, Tolerability, PK and PD of DCR-PHXC in PH Type 3 Patients

NCT04555486 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2024-09-19

No results posted yet for this study

Summary

The DCR-PHXC-104 study is designed to assess the safety, tolerability, and pharmacological parameters of a single dose of DCR-PHXC in Primary Hyperoxaluria Type 3 (PH3). Participants should have had at least one stone event within 12 months of screening and intact renal function.

Conditions

  • Primary Hyperoxaluria Type 3

Interventions

DRUG

DCR-PHXC

Intervention, drug, DCR-PHXC

DRUG

Sterile Normal Saline (0.9% NaCl)

Placebo comparator

Sponsors & Collaborators

  • Dicerna Pharmaceuticals, Inc., a Novo Nordisk company

    lead INDUSTRY

Principal Investigators

  • Alexandra Haagensen, MD, MBA · Dicerna Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-14
Primary Completion
2021-09-07
Completion
2021-09-07
FDA Drug
Yes

Countries

  • United States
  • Germany
  • Netherlands
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04555486 on ClinicalTrials.gov