NCT05791591

Safety and Efficacy of Orally Administered NUV001 Nutraceutical Supplement in Sickle Cell Disease Patients

A Multicenter, Randomized, Double Blind, Placebo Controlled Study to Evaluate Safety and Efficacy of Orally Administered NUV001 Nutraceutical Supplement in Sickle Cell Disease Patients.

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 168 (actual)
• Sponsor: LGD · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

A total of 170 patients male or female who are carrying SS or Sbeta0 versions of the beta globin gene will be included in the study. The subjects will be assigned with 1:1:1 ratio of either NUV001 Immediate release IR or NUV001 Gastro resistant GR or Placebo. The treatment duration of the study will be 90 days which has in total 5 visits. The primary end point of this study is to check the safety and tolerance of the orally administered nutraceutical supplement. This endpoint will be checked by assessing the Adverse events, Vital signs of the subject and the Change in hematological parameters from Baseline to Final visit.

Conditions

• Sickle Cell Disease

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	NUV001 - IR	Daily supplementation with 1000 mg of NUV001 (in two administration orally) immediate release gel capsule formulation for 90 days in total
DIETARY_SUPPLEMENT	NUV001 - GR	Daily supplementation with 1000 mg of NUV001 (in two administration orally) gastro resistant gel capsule formulation for 90 days in total
DIETARY_SUPPLEMENT	Placebo	Placebo containing starch Powder (1000 mg, daily in two administration orally for 90 days)

Timeline

• Start date: 2023-04-15
• Primary completion: 2024-10-31
• Completion: 2024-11-30
• First posted: 2023-03-30
• Last updated: 2024-05-28

Locations

8 sites across 1 country: India