Status:
COMPLETED
Ketohexokinase Inhibition in Hereditary Fructose Intolerance
Lead Sponsor:
Maastricht University Medical Center
Collaborating Sponsors:
Pfizer
Conditions:
HFI
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Hereditary fructose intolerance (HFI) is a rare inborn error of metabolism. Patients with HFI develop acute abdominal pain, nausea, vomiting, hypoglycemia and proximal tubular dysfunction upon consump...
Detailed Description
Rationale: Hereditary fructose intolerance (HFI) is a rare inborn error of metabolism. Patients with HFI develop acute abdominal pain, nausea, vomiting, hypoglycemia and proximal tubular dysfunction u...
Eligibility Criteria
Inclusion
- Participants are able to provide signed and dated written informed consent prior to any study specific procedures
- Use of effective contraception (only applicable to premenopausal women; a pregnancy test will be performed in these women at baseline)
- Aged ≥ 18 years
Exclusion
- Diabetes mellitus
- Pregnancy
- Patients with congestive heart failure and/or severe renal and or liver insufficiency
- Uncontrolled hypertension
- Previous enrolment in a clinical study with an investigational product during the last 3 months or as judged by the investigator which would possibly hamper our study results
- Use of drugs that inhibit organic anion transporting polypeptide B1 (OATPB1) transporters (e.g. rifampicin, gemfibrozil, ciclosporine, erythromcyin and clarithromycin)\*
- Treatment with irinotecan\* Any contra-indications for MRI scanning\*
- Subjects who do not want to be informed about unexpected medical findings
- Exclusion criterion for HFI patients only.
Key Trial Info
Start Date :
June 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2023
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT06089265
Start Date
June 15 2023
End Date
November 30 2023
Last Update
January 24 2024
Active Locations (1)
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1
Maastricht University Medical centre
Maastricht, Limburg, Netherlands, 6202AZ