Informations générales (source: ClinicalTrials.gov)
Effect of NUV001 Supplementation for 120 Days in Patients Suffering From Sickle Cell Disease (SCD) S Homozygous (SS) Genotype: A Pilot Study
Interventional
N/A
LGD (Voir sur ClinicalTrials)
avril 2023
juin 2024
29 juin 2024
This is a pilot study of daily dosing of NUV001 as a dietary supplement in 12 sickle cell
disease patients with 3 months of follow-up plus 1 month after supplementation.The
present study is designed to evaluate, first, the safety and tolerability parameters as
well as to measure the plasma and urinary residues of daily oral doses of NUV001.
Secondly, the study will evaluate the impact of NUV001 on biological parameters and
quality of life of patients.
Etablissements
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Aphm Hopital La Timone Adultes Sce Medecine Interne (Umap) - 13005 - Marseille - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
1. Man or woman comprised between 18 and 60 years old.
2. Patients diagnosed with homozygous sickle cell anemia of SS genotype (documented by
genotyping).
3. Females of childbearing potential should be using one of the following acceptable
methods of birth control:
- Intrauterine Device (IUD) in place for at least 60 days prior to the first dose
of the study throughout the study and for 30 days after completion of the
study.
- Hormonal contraceptives for at least 90 days prior to the first dose of the
study throughout the study, and for 30 days after study completion.
4. Patients whose weight is greater than 50 kg.
5. Patient that has been treated with an anti-sickling agent (Hydroxyurea) within six
months of the screening visit, must maintain the therapy continuous and unmodified
for at least six months with the intent to continue for the duration of the study.
6. Patient available to attend on an outpatient basis for visits provided for in the
protocol and able to complete the data collection documents (and quality of life
scale).
7. Patient has given written informed consent.
8. Patient with health insurance scheme
1. Man or woman comprised between 18 and 60 years old.
2. Patients diagnosed with homozygous sickle cell anemia of SS genotype (documented by
genotyping).
3. Females of childbearing potential should be using one of the following acceptable
methods of birth control:
- Intrauterine Device (IUD) in place for at least 60 days prior to the first dose
of the study throughout the study and for 30 days after completion of the
study.
- Hormonal contraceptives for at least 90 days prior to the first dose of the
study throughout the study, and for 30 days after study completion.
4. Patients whose weight is greater than 50 kg.
5. Patient that has been treated with an anti-sickling agent (Hydroxyurea) within six
months of the screening visit, must maintain the therapy continuous and unmodified
for at least six months with the intent to continue for the duration of the study.
6. Patient available to attend on an outpatient basis for visits provided for in the
protocol and able to complete the data collection documents (and quality of life
scale).
7. Patient has given written informed consent.
8. Patient with health insurance scheme
1. Patient with known or suspected allergy to any ingredient of the food supplement .
2. Patient having consumed food supplements containing tryptophan, glutamine or vitamin
B3 in its various forms (nicotinic acid/niacin and nicotinamide) during the month
before selection
3. Patient has a significant medical condition that required hospitalization (other
than sickle cell crisis) within two months of the screening visit.
4. Patient has serum albumin < 3.0 g/dl.
5. Patient has been transfused and received any blood products within three months of
the Screening Visit.
6. Patient has been hospitalized for acute vaso-occlusive crisis within one months of
the Screening Visit.
7. Patient has clinically significant, cardiovascular or liver disease, renal or lung
insufficiency or lymphopenia (with clinically significant abnormal results on the
screening bioassays: complete blood count, transaminases (ASAT, ALAT, GGT, ALP),
bilirubin, creatinine, CPK, Ionogram, blood glucose, lipid profile).
8. Patients with diagnosed cancer in the past 2 years
9. Pregnant or lactating woman. Woman of childbearing potential should have a negative
(serum or urinary TBD) pregnancy test at screening and a negative urine pregnancy
test at inclusion prior to administration of the Study Product.