Effect of NUV001 Supplementation in Patients Suffering From Sickle Cell Disease (SCD)

Korábbi kezelés

• Patients who have consumed food supplements containing tryptophan, glutamine or vitamin B3 in various forms (nicotinic acid/niacin and nicotinamide) during the month before selection.
• Patients have been transfused and received any blood products within three months of the Screening Visit (Visit 0).

Más betegség

• Patients have a significant medical condition that required hospitalization (other than sickle cell crisis) within two months of the screening visit (Visit 0).
• Patients with a diagnosed cancer in the past 2 years.

Laborértékek

• Patients with known or suspected allergies to any ingredient of the food supplement (β-NMN, Isomalt, Magnesium stearate, microcrystalline cellulose).
• Patients have serum albumin < 3.0 g/dl (< 30 g/L).
• Patient has clinically significant cardiovascular or liver disease, renal or lung insufficiency or lymphopenia (with clinically significant abnormal results on the screening bioassays: CBC, transaminases (AST, ALT, GGT, ALP), bilirubin, creatinine, CPK, ionogram, blood glucose, lipid profile).
• Pregnant or lactating woman. Women of childbearing potential should have a negative serum or urine pregnancy test at screening and a negative urine pregnancy test at inclusion prior to administration of the study product.

Egyéb

• Participants meeting the following criteria could not be included:
• Patients have been hospitalized for acute vaso-occlusive crisis within one month of the Screening Visit (Visit 0).

• Participants meeting the following criteria could be included:
• Male or female between 18 and 60 years old.
• Females of childbearing potential should be using one of the following acceptable methods of birth control:
  • Intrauterine Device in place for at least 60 days prior to the first dose of the study (Visit 1) 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 (Visit 1) throughout the study, and for 30 days after study completion.
• Patients whose weight is greater than 50 kg.
• Patients diagnosed with homozygous sickle cell anemia of SS genotype (documented by genotyping).
• Patients who have been treated with an anti-sickling agent (Siklos®) within six months of the screening visit (Visit 0) must maintain the therapy continuous and unmodified for at least six months with the intent to continue for the duration of the study.
• Patients who are available to attend on an outpatient basis for visits provided for in the protocol and can complete the data collection documents (and quality of life scale).
• Patients have given written informed consent.
• Patients with a health insurance coverage.