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New treatment option for Primary Hyperoxaluria Type 1 (PH1)
Official title Phase 1/2 Study of ABO-101 in Primary Hyperoxaluria Type 1 (redePHine)
ClinicalTrials.gov ID: NCT06839235
What this study is testing
What is ABO-101?
ABO-101 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for primary hyperoxaluria type 1 (ph1).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The goal of the redePHine study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ABO-101 in participants with primary hyperoxaluria type 1 (PH1). The trial will consist of 2 Study Periods.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 6 to 64
You may be able to join if
- Key for Parts A and B
- Documentation of PH1 as determined by genetic analysis confirming pathogenic mutations in the alanine-glyoxylate aminotransferase (AGXT) gene (valid...
- Age at time of signing the informed consent/assent form:
- Part A: ≥18 years to ≤64 years
- Part B: ≥6 years to \<18 years
You likely can't join if
- for Parts A and B
- Confirmed diagnosis of primary hyperoxaluria type 2 or type 3
- History of a liver, kidney or combined liver/kidney transplant
- Currently on dialysis
- Participant has previously used (within past 24 months) or is currently receiving an approved or investigational urinary oxalate lowering RNA...
- Female participants who are pregnant or breastfeeding (or are planning either during the first 12 months)
See the full eligibility criteria
- Key for Parts A and B
- Documentation of PH1 as determined by genetic analysis confirming pathogenic mutations in the alanine-glyoxylate aminotransferase (AGXT) gene (valid historical laboratory data will be reviewed and approved by the...
- Age at time of signing the informed consent/assent form:
- Part A: ≥18 years to ≤64 years
- Part B: ≥6 years to \<18 years
- 24-hour UOx ≥0.7 mmol/24 hours/1.73 m²
- eGFR ≥30 mL/min/1.73m²
- Weight ≤90 kg Key
- for Parts A and B
- Confirmed diagnosis of primary hyperoxaluria type 2 or type 3
- History of a liver, kidney or combined liver/kidney transplant
- Currently on dialysis
- Participant has previously used (within past 24 months) or is currently receiving an approved or investigational urinary oxalate lowering RNA interference (RNAi) or siRNA therapy
- Female participants who are pregnant or breastfeeding (or are planning either during the first 12 months)
The study team makes the final eligibility decision.
Where it's taking place
- Rochester, Minnesota, United States
- Saint Paul, Minnesota, United States
- Lyon, France
- Bonn, Germany
- Sfax, Tunisia
- Birmingham, United Kingdom
- London, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 6 years to 64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rochester, Minnesota, United States; Saint Paul, Minnesota, United States; Lyon, France; Bonn, Germany; Sfax, Tunisia; Birmingham, United Kingdom and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.