An interventional study of NUV001 in Sickle Cell Disease, sponsored by LGD. Completed at 1 site in France. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-06-17.
Sponsored by LGD · Not applicable, Interventional, and Treatment
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.
This is a monocentric, prospective, open-label pilot study designed for 12 adult patients suffering of Sickle Cell disease (SCD) SS genotype each 12 receiving the active supplementation of NUV001, 1000mg/day (4 x 250 mg tablet) for 3 months of follow-up plus 1 month after supplementation. A stratification according to the medical treatment is planned. At least 2 patients suffering of SCD SS genotype without hydroxyurea treatment and maximum 10 patients suffering of SCD SS genotype in association with hydroxyurea treatment. If a subject is withdrawn from this study part, the subject may be replaced as necessary with another subject assigned to the same treatment at the discretion of the sponsor's team in consultation with the investigator.
The current study is designed to assess in the first part, the safety, tolerability, plasma, and urine residual rate parameters of daily oral doses of NUV001 as food supplement in adult patients with SCD, SS genotype. In a second part, the study will assess the pharmacological impact of NUV001 on biological parameters and the quality of life in patient suffering of sickle cell disease SS genotype.
1,103 studies on the registry are indexed under Anemia, Sickle Cell; 235 are open to participants now.
This study's enrollment of 12 is below the median of 40 across 750 interventional studies indexed under Anemia, Sickle Cell.
Browse Anemia, Sickle Cell studies →LGD is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Females of childbearing potential should be using one of the following acceptable methods of birth control:
Exclusion criteria:
Daily supplementation with NUV001 1000 mg
Dietary Supplement: NUV001
Daily supplementation with NUV001 at 1000 mg (4 tablets of 250 mg each) for 90 days with a prolonged follow-up of 1 month (30 days) after stopping the supplementation
Incidence of adverse events and treatment-emergent adverse events through Day 120.
Participant incidence of AEs/TEAEs, including vaso-occlusive crises and SCD-related hospitalizations, from first dose through Day 120.
Time frame: First dose through Day 120.
Clinically significant changes in laboratory safety parameters through Day 120.
Clinically significant changes from baseline through Day 120 in hematology, CRP, liver function tests, renal function tests, CPK, electrolytes, fasting glucose, and albumin.
Time frame: Baseline through Day 120.
Clinically significant changes in vital signs through Day 120.
Clinically significant changes from baseline through Day 120 in systolic blood pressure, diastolic blood pressure, pulse rate, body temperature, and body weight if retained as part of tolerability assessment.
Time frame: Baseline through Day 120.
Change from baseline in hematologic parameters through Day 120.
Change from baseline through Day 120 in Red Blood Cell count, Hemoglobin, Hematocrit, Mean Corpuscular Volume, Mean Corpuscular Hemoglobin, Mean Corpuscular Hemoglobin Concentration, and Reticulocyte count.
Time frame: Baseline (Day 0), Day 15, Day 30, Day 60, Day 90, Day 120.
Change from baseline in markers of hemolysis through Day 120.
Change from baseline through Day 120 in Lactate DeHydrogenase and Bilirubin parameters as markers of hemolysis.
Time frame: Baseline (Day 0), Day 15, Day 30, Day 60, Day 90, Day 120.
Change from baseline in Fetal Hemoglobin-related erythroid parameters through Day 120.
Change from baseline through Day 120 in percentage of F-cells, percentage of F-reticulocytes, and distribution of hemoglobin F expression within F-cells.
Time frame: Baseline (Day 0), Day 15, Day 30, Day 60, Day 90, Day 120.
Change from baseline in sickling-related Red Blood Cell parameters through Day 120.
Change from baseline through Day 120 in percentage of irreversibly sickled cells and in vitro hypoxia-induced Red Blood Cell sickling.
Time frame: Baseline (Day 0), Day 15, Day 30, Day 60, Day 90, Day 120.
Change from baseline in blood β-NMN and NAD+ concentrations through Day 120.
Change from baseline through Day 120 in whole blood β-Nicotinamide mononucleotide (β-NMN) and nicotinamide adenine dinucleotide (NAD+) concentrations.
Time frame: Baseline (Day 0), Day 15, Day 30, Day 60, Day 90, Day 120.
Change from baseline in plasma NAD-related metabolites through Day 120.
Change from baseline through Day 120 in plasma nicotinamide (NAM) and 1-methylnicotinamide (MeNAM) concentrations.
Time frame: Baseline (Day 0), Day 15, Day 30, Day 60, Day 90, Day 120.
Change from baseline in urinary NAD-related metabolites through Day 120.
Change from baseline through Day 120 in urinary 1-methylnicotinamide (MeNAM) and 2PY concentrations.
Time frame: Baseline (Day 0), Day 15, Day 30, Day 60, Day 90, Day 120.
Change from baseline in health-related quality of life through Day 120.
Change from baseline through Day 120 in Short Form-36 (SF-36) questionnaire domain scores and summary scores.
Time frame: Baseline (Day 0), Day 15, Day 30, Day 60, Day 90, and Day 120.
Change from baseline in pain outcomes through Day 120.
Change from baseline through Day 120 in pain severity and pain interference scores assessed using the Brief Pain Inventory questionnaire.
Time frame: Baseline (Day 0), Day 15, Day 30, Day 60, Day 90, and Day 120
Change from baseline in analgesic use through Day 120.
Change from baseline through Day 120 in use of analgesic and opioid medications, assessed using recorded concomitant medication use and equianalgesic conversion where applicable.
Time frame: Baseline (Day 0) through Day 120.
Plan to share: No
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