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Anti-metabolites

NDec for Sickle Cell Disease (ASCENT1 Trial)

Phase 2

Recruiting

Research Sponsored by Novo Nordisk A/S

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

2-10 episodes of documented vaso-occlusive crisis (VOCs) within the last 12 months prior to the screening visit

Body weight 40 to 125 kg (inclusive)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline (week 0) to week 52

Awards & highlights

ASCENT1 Trial 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.

Who is the study for?

Adults over 18 with sickle cell disease (SCD), having had 2-10 pain episodes in the last year, and specific blood criteria can join. Excluded are those on chronic transfusions, recent other treatments for SCD, certain blood counts outside normal ranges, pregnant or breastfeeding women, and those not using effective contraception.Check my eligibility

What is being tested?

The trial is testing NDec—a new oral medication combining decitabine-tetrahydrouridine—against a placebo and Hydroxyurea (HU) in people with SCD. Participants will be randomly assigned to receive either NDec capsules twice weekly or continue HU/placebo for about a year.See study design

What are the potential side effects?

Potential side effects of NDec aren't detailed here but may include typical drug reactions such as digestive issues, possible blood count changes due to its nature as a treatment for SCD. Side effects from HU could involve skin ulcers, nausea, headache and dizziness.

ASCENT1 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had 2-10 painful episodes related to my condition in the last year.

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My weight is between 40 and 125 kg.

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I have been diagnosed with sickle cell disease.

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I am 18 years old or older.

ASCENT1 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline (week 0) to week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline (week 0) to week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline (week 0) to week 52 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in total haemoglobin

Secondary outcome measures

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

+11 more

ASCENT1 Trial Design

6Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: HU-non-eligible - NDec plus placeboExperimental Treatment2 Interventions

HU-non eligible patients randomised to treatment with NDec on one day and placebo on the other day

Group II: HU-non-eligible - NDec plus NDecExperimental Treatment1 Intervention

HU-non eligible patients randomised to treatment with NDec on both days

Group III: HU-active - NDec plus placeboExperimental Treatment2 Interventions

HU-active patients randomised to treatment with NDec on one day and placebo on the other day

Group IV: HU-active - NDec plus NDecExperimental Treatment1 Intervention

HU-active patients randomised to treatment with NDec on both days

Group V: HU-active - HUActive Control1 Intervention

HU-active patients randomised to continue on open-label HU treatment

Group VI: HU-non-eligible - Placebo plus placeboPlacebo Group1 Intervention

HU-non eligible patients randomised to treatment with placebo on both days

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Novo Nordisk A/SLead Sponsor

1,514 Previous Clinical Trials

2,414,984 Total Patients Enrolled

Clinical Transparency (dept. 2834)Study DirectorNovo Nordisk A/S

106 Previous Clinical Trials

139,742 Total Patients Enrolled

Media Library

NDec (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT05405114 — Phase 2

Sickle Cell Disease Research Study Groups: HU-non-eligible - Placebo plus placebo, HU-non-eligible - NDec plus NDec, HU-non-eligible - NDec plus placebo, HU-active - HU, HU-active - NDec plus placebo, HU-active - NDec plus NDec

Sickle Cell Disease Clinical Trial 2023: NDec Highlights & Side Effects. Trial Name: NCT05405114 — Phase 2

NDec (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05405114 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Research Study Investigating How Well NDec Works in People With Sickle Cell Disease

2022. "Research Study Investigating How Well NDec Works in People With Sickle Cell Disease". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05405114.

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