Questions about
HIBISCUS2
Who can join the clinical trial?
This trial will include about 400 people with SCD. You may be able to join if you:
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Are age 12 or older
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Have been diagnosed with sickle cell disease by a doctor
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This includes genotypes like HbSS, HbSC, HbSβ0-thalassemia, HbSβ+-thalassemia, and more. Ask your doctor if you don’t know your genotype.
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Have had between 2 - 15 sickle cell pain crises in the past year
You may not be able to join if you:
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Have had fewer than 2 or more than 15 pain crises in the past year
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Get regular blood transfusions (more than 6 transfusions in the past year)
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Are pregnant, breastfeeding, or planning to become pregnant during the trial
The full list of eligibility criteria can be found at ClinicalTrials.gov
Participating in a clinical trial is always your choice. You can decide not to join. Or you can join and later choose to leave at any time. If you decide to leave, it’s helpful to share your reasons with the clinical trial team. This feedback can help make the trial process better for you and for others in the future.
When will this trial start?
Trial enrollment is currently ongoing.
What will happen in this trial?
Each individual in the clinical trial will participate for approximately 2 years. During that time, you will have regular visits to a trial site to do some common medical tests, such as:
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Physical exams
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Blood and urine (pee) tests
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Heart ultrasounds and electrocardiograms (or ECG), which are tests to see how well your heart is working
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6-minute walking tests, which measure how far you can walk
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Filling out questionnaires about your pain, SCD symptoms, and well-being
You will also keep a daily record of your pain levels and any pain episodes.
If I join this trial, will I take etavopivat*?
In the 1st year, you will be randomly assigned to take either etavopivat* or a placebo (an inactive pill). For every 3 people, 2 will get etavopivat*, and 1 will get the placebo. So, you have a higher chance of getting etavopivat* than a placebo in the 1st year.
In the 2nd year, all participants will receive etavopivat*.
How is etavopivat* designed to work?
Here’s how etavopivat* is designed to work:
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Etavopivat* helps activate a protein in your body called pyruvate kinase R (PKR).
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When activated, PKR helps red blood cells make more energy and better carry oxygen around your body.
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This helps make your red blood cells a normal shape, instead of a “sickle” shape.
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With a normal shape, your red blood cells:
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Live longer, which eases anemia symptoms
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Stop clumping together, which eases pain
What are the possible risks and side effects of etavopivat*?
The potential risks and side effects of etavopivat* will be discussed with you by the study doctor during the informed consent process. The study doctor will provide you with the most current safety information before you make a decision about trial participation. This detailed discussion of risks and benefits is an essential part of the consent process, ensuring you have all the information needed to make an informed choice about participating in the study.
Can I keep taking my usual medicines during this trial?
Yes, you can (and should) continue to take your usual SCD medicines.
However, you can’t take certain other medicines or substances during the trial because they may interfere with etavopivat*. Your SCD doctor and the HIBISCUS2 trial team will review all your medicines before you can join the trial.
What if I change my mind and want to leave this trial?
You can leave this trial at any time without giving a reason.
If you decide to leave, talk to your clinical trial doctor first to talk about your next steps. They will also talk about your future treatment options. You’ll still continue to take your usual SCD medicines, just as you were before and during this trial.
Will my personal information be kept private?
Yes, your personal information, such as your name and medical records, will be kept private.
When the research team shares trial information, they will not use people’s names. Instead, people will be assigned a unique number that is linked to their identity through a secure code list. Only their trial doctor can see and access this list. It will also be permanently deleted after 25 years or as required by law.
The only people allowed to see your clinical trial information includes:
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Your clinical trial doctor and research team
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Novo Nordisk staff (for monitoring and auditing)
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Ethics committees and health authorities (such as the FDA)
In any reports, presentations, or results summaries, Novo Nordisk, Inc. will not include any information that can identify you.
How long will my information be stored?
Your clinical trial information will be stored for 25 years after the trial ends, or longer if required by law.
What happens after this trial ends?
After the trial ends, everyone will be able to read a summary of the results on websites such as:
Novo Nordisk will report all the results, both positive and negative, and discuss all the trial’s strengths and limits. These results will not include any information that can identify you.
You can also ask your trial doctor for information about your treatment and the overall trial results after the trial ends.
Where can I learn more about this trial?
To learn more about this trial, you can visit ClinicalTrials.gov - NCT06612268 .
This will lead you to a page that has more details about this trial. You will also be able to read about the results on this page after the trial ends.
You may also see this trial referred to by its official title or other ID numbers:
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The trial’s official title: A global phase 3, randomized, double-blind and placebo-controlled study evaluating the efficacy and safety of etavopivat* in adolescents and adults with sickle cell disease.
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Other ID numbers: NN7535-7807, U1111-1298-3431, 2023-509175-16, NCT06612268
Other clinical trials for SCD and other conditions
If you are interested in other clinical trials for SCD, or trials for other conditions, you can search with these clinical trial finders:
Etavopivat is not approved for the treatment of sickle cell disease. Safety and efficacy are not established. There is no guarantee that Etavopivat will become commercially available for the use(s) under investigation.
* Disclaimer