Status:
SUSPENDED
Effect of Acetaminophen and N-Acetylcysteine on Liver Metabolism on Homocystinuria
Lead Sponsor:
Hospital de Clinicas de Porto Alegre
Collaborating Sponsors:
Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
Conditions:
CBS Deficiency
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
In homocystinuria due to cystathionine beta synthase (CBS) deficiency or classical homocystinuria, decreased blood cysteine levels are observed. Cysteine is essential for the synthesis of molecules su...
Detailed Description
STUDY PROCEDURES A phase I-II clinical cross-over, not blinded, trial will be conducted. Adult patients with homocystinuria and paired-sex and age- healthy controls will be enrolled. Individuals with...
Eligibility Criteria
Inclusion
- Age over 18 years
- For patients: molecular diagnosis of homocystinuria due to cystathionine beta synthase (CBS) deficiency
Exclusion
- Gastric, hepatic or kidney disease
- Smoking
- Illicit drug users;
- Acetaminophen or N-acetylcysteine hypersensitivity.
- Controls: use of vitamins supplements
Key Trial Info
Start Date :
February 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04015557
Start Date
February 11 2022
End Date
December 1 2022
Last Update
June 30 2021
Active Locations (1)
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1
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90035-007