Study of YOLT-203 in Children and Adults With Primary Hyperoxaluria Type 1 (PH1)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age6+
SponsorYolTech Therapeutics Co., Ltd
About this trial
This study will be conducted to evaluate the efficacy and safety of YOLT-203 in children and adults with Primary Hyperoxaluria Type 1.
After the initial randomized, 6-month double-blind, placebo-controlled period, participants who were initially assigned to placebo will receive a single-dose of YOLT-203 treatment whereas participants in the YOLT-203 group will receive a single-dose of placebo infusion.
Eligibility criteria
Qualifiers
You are 6 years old or older.
You have been diagnosed with PH1 (primary hyperoxaluria type 1) through genetic testing.
Urine tests show that your oxalate levels are not within certain limits (based on at least two 24-hour urine collections).
If you take vitamin B6, your dose has been stable for at least 3 months, and you are willing to keep it the same during the study.
Disqualifiers
You have signs that oxalate has affected parts of your body outside the kidneys.
Your liver blood tests are not within certain limits.
You have certain abnormal blood clotting results (unless controlled with medication like warfarin).
You have HIV, or active or chronic hepatitis C.
Trial design
Treatments tested in this trial
- YOLT-203
- Placebo
Treatment groups
36 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov