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HU-active - NDec plus NDec for Sickle Cell Disease

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Novo Nordisk Investigational Site, Metairie, LASickle Cell DiseaseNDec - oral decitabine-tetrahydrouridine - Drug
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trialwill study a new medicine combo to treat sickle cell disease. Participants will get NDec, placebo, or Hydroxyurea, and take capsules twice weekly for a year.

Eligible Conditions
  • Sickle Cell Disease

Treatment Effectiveness

Effectiveness Progress

1 of 3

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1
Arm 1 (L-citrulline)
1
EDIT-301
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Voxelotor

Study Objectives

1 Primary · 14 Secondary · Reporting Duration: From baseline (week 0) to week 52

At week 24
Cmax for decitabine from pharmacokinetic assessment
Cmax for tetrahydrouridine from pharmacokinetic assessment
Week 24
Change in DNA methyltransferase 1 (DNMT1) activity
Change in F-cell level as a proportion of total red blood cell (RBC) (%F-cells)
Change in cytidine deaminase (CDA) activity
Change in foetal haemoglobin (g/dL)
Change in foetal haemoglobin as a proportion of total haemoglobin (%HbF)
Change in haemolysis measure: absolute reticulocyte count
Change in haemolysis measure: indirect bilirubin
Change in haemolysis measure: lactate dehydrogenase
Change in total haemoglobin
Week 48
Number of RBC units transfused
Number of acute chest syndrome
Number of vaso-occlusive crises
Week 52
Number of adverse events of grade 3 or higher

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Similar Trials

1
Arm 1 (L-citrulline)
1
EDIT-301
1
Voxelotor

Trial Design

6 Treatment Groups

HU-active - HU
1 of 6
HU-active - NDec plus placebo
1 of 6
HU-active - NDec plus NDec
1 of 6
HU-non-eligible - NDec plus NDec
1 of 6
HU-non-eligible - NDec plus placebo
1 of 6
HU-non-eligible - Placebo plus placebo
1 of 6

Active Control

Experimental Treatment

Non-Treatment Group

84 Total Participants · 6 Treatment Groups

Primary Treatment: HU-active - NDec plus NDec · Has Placebo Group · Phase 2

HU-active - NDec plus placeboExperimental Group · 2 Interventions: NDec - oral decitabine-tetrahydrouridine, Placebo · Intervention Types: Drug, Drug
HU-active - NDec plus NDec
Drug
Experimental Group · 1 Intervention: NDec - oral decitabine-tetrahydrouridine · Intervention Types: Drug
HU-non-eligible - NDec plus NDec
Drug
Experimental Group · 1 Intervention: NDec - oral decitabine-tetrahydrouridine · Intervention Types: Drug
HU-non-eligible - NDec plus placeboExperimental Group · 2 Interventions: NDec - oral decitabine-tetrahydrouridine, Placebo · Intervention Types: Drug, Drug
HU-non-eligible - Placebo plus placebo
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug
HU-active - HU
Drug
ActiveComparator Group · 1 Intervention: HU - Hydroxyurea · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2640

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from baseline (week 0) to week 52

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor
1,422 Previous Clinical Trials
2,313,274 Total Patients Enrolled
Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S
56 Previous Clinical Trials
73,484 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 11 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

Frequently Asked Questions

Has the FDA given authorization for HU-active - NDec plus NDec?

"The safety of HU-active - NDec plus NDec was measured to be a 2 on the 1-3 scale as this clinical trial is in Phase 2, indicating that there are some studies affirming its security but no data yet confirming efficacy." - Anonymous Online Contributor

Unverified Answer

How many individuals are receiving treatment as part of this clinical trial?

"Affirmative. Content from clinicaltrials.gov suggests that this research project, which was initially published on July 7th 2022, is currently recruiting trial subjects. Approximately 84 individuals are envisioned to be recruited across 17 different medical sites." - Anonymous Online Contributor

Unverified Answer

Is enrollment still taking place for this clinical examination?

"Per the data available on clinicaltrials.gov, this medical investigation is open for recruitment. It was originally posted on July 7th 2022 and most recently amended a month ago - November 10th 2022." - Anonymous Online Contributor

Unverified Answer

Are there any North American sites involved in the execution of this trial?

"This medical trial is taking place in 17 different sites, including Aurora, Oklahoma City and Philadelphia. To minimize necessary travel for enrolled patients, it's advised to register with the closest clinic." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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