Phase 3 Sickle Cell Disease Trial, Recruiting NCT06609226 Sponsor: Novo Nordisk A/S Condition: Sickle Cell Disease
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Phase 3 Sickle Cell Disease Trial, Recruiting

NCT06609226
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who are currently taking part in a related ("parent") study of a drug called etavopivat for sickle cell disease or thalassaemia, and who have completed at least the main treatment period of that study.
  • People whose doctor (the investigator) has determined that they have received a clear medical benefit from taking etavopivat.
  • People who had their dose reduced or temporarily stopped during the parent study, but who have since successfully returned to the full dose of etavopivat before transferring into this trial.
  • People who are also taking hydroxyurea, crizanlizumab, or a medicine called L-glutamine (Endari®) may be considered eligible if their doctor determines they have been on a stable dose during the parent study — including cases where minor adjustments were made for weight, age, or temporary medical reasons.

Who may not be able to join:

  • People who have a medical condition (other than sickle cell disease or thalassaemia) that the investigator believes could put their safety at risk or make it difficult to follow the trial requirements.
  • People who withdrew from the etavopivat parent study, or whose treatment was permanently stopped.
  • People who are on a permanent dose reduction lasting more than 28 days, or whose treatment is currently on hold.
  • People who have used certain specific medications during the parent study or who are expected to need them during this trial, including: medicines that stop haemoglobin S from clumping together; experimental medicines that block a protein called selectin; erythropoietin or similar medicines that stimulate blood cell production (if used for more than 4 weeks in a row during the parent study, or expected as ongoing treatment); or strong "CYP3A4 inducer" medicines taken within 2 weeks before joining this trial (confirm with trial site if unsure whether a current medication falls into this category).
  • People who are currently participating in any other clinical study that is not the designated etavopivat parent study, or who plan to join another clinical study while this trial is running.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Clinical Transparency (dept. 2834), Novo Nordisk A/S

Phone: (+1) 866-867-7178

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
10 January 2025
Est. completion
30 December 2030

Where this trial is recruiting

🇨🇦 Canada 🇪🇬 Egypt 🇫🇷 France 🇩🇪 Germany Ghana 🇬🇷 Greece 🇮🇳 India 🇮🇹 Italy Kenya 🇱🇧 Lebanon Nigeria Oman 🇸🇦 Saudi Arabia 🇪🇸 Spain Turkey (Türkiye) 🇬🇧 United Kingdom 🇺🇸 United States

Primary endpoints

Number of treatment emergent adverse events (TEAEs), reported for each indication and age group separately; Number of adverse reactions, reported for each indication and age group separately

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov