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NCT05405114 (NDec in sickle cell disease): BVCT ex-ante prediction vs. reported outcome

On 24 Mar 2024, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 6 May 2026 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT05405114
Acronym
ASCENT1
Drug Name
NDec
Drug MoA
combination of decitabine and tetrahydrouridine
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Hemic and Lymphatic Diseases
Indication
sickle cell disease
Human Patients
96
Sponsor
Novo Nordisk
Phase
Phase 2

Prediction of , index 1522

Prospective Prediction
Prediction Index
1522
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit)
Technical Prediction
FAILURE (statistically insignificant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
773 days in advance
Readout Data Interpretation
NDec achieved a numerical trend yet statistically insignificant total Hb response compared with placebo
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically insignificant and commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
A Multicentre Trial Evaluating the Efficacy and Safety of Oral Decitabine Tetrahydrouridine (NDec) in Patients With Sickle Cell Disease
Phase
Phase 2
Status
Completed
Enrollment
96
Lead sponsor
Novo Nordisk A/S
Conditions
Sickle Cell Disease
Interventions
DRUG: NDec - oral decitabine-tetrahydrouridine; DRUG: HU - Hydroxyurea; DRUG: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2022-07-07
Primary completion
2025-07-24
Completion
2025-07-24
Primary outcomes
  • Change in total haemoglobin (From baseline (week 0) to week 24)

NCT05405114 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials