NCT03391804

Study of ALLN-177 in Patients Aged 12 Years or Older With Enteric or Primary Hyperoxaluria and Hyperoxalemia

Pilot Study of ALLN-177 in Adult and Pediatric Subjects Aged 12 Years or Older With Enteric or Primary Hyperoxaluria and Hyperoxalemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Allena Pharmaceuticals · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

Evaluate the efficacy and safety of ALLN-177 in reducing plasma and urinary oxalate levels in adult and pediatric patients with enteric hyperoxaluria and hyperoxalemia or primary hyperoxaluria

Detailed description

Phase 2, multi-center, open label, single arm study to evaluate the effect and safety of ALLN-177 in adult and pediatric patients aged 12 and older with enteric hyperoxaluria and hyperoxalemia or primary hyperoxaluria . Approximately 15-20 evaluable subjects are planned to be enrolled in the study. Eligible subjects will administer ALLN-177 with each meal/snack 5 times per day for 12 consecutive weeks.

Conditions

• Enteric Hyperoxaluria
• Primary Hyperoxaluria
• Hyperoxalemia

Interventions

Type	Name	Description
DRUG	ALLN-177	ALLN-177 7,500 units (2 capsules) with each meal/snack by mouth 5 times per day for 12 weeks

Timeline

• Start date: 2018-07-17
• Primary completion: 2019-12-13
• Completion: 2019-12-13
• First posted: 2018-01-05
• Last updated: 2020-12-30

Locations

9 sites across 3 countries: United States, Germany, United Kingdom

Regulatory

• FDA-regulated drug study