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Welcome – What can you learn here?

Supporting you to learn more about Roche clinical trials for P Vera

We support an online community of people impacted by Polycythemia Vera (PV, or P Vera). Browse this site for insights about P Vera, and information about P Vera clinical trials.

Scroll down to view our doctor-approved Questions & Answers section about P Vera. There you can find explanations about important medical terms and insights about the purpose of Roche’s new Study NP39761 trial for P Vera.

It is our wish that this website can support you with knowledge and insights about clinical trials for P Vera. The more you know, the more you can participate in your treatment decisions and support others who are living with P Vera.

How do we support you as you learn about clinical trials?

We can put you in contact with people who can answer your questions about Roche clinical trials. These people can be reached by email and you can arrange to be contacted over the phone.

Use the link below to find the nearest contact person that is able to answer your questions.

 

You might be asking how you can prepare yourself, personally, to find your way forward?

Today’s clinical trials may have a critical impact on how P Vera is treated in future.

When a treatment being studied in a clinical trial, which is called an investigational treatment, shows positive results it may later become the standard treatment for P Vera patients.

Have you talked to your doctor about participating in a P Vera clinical trial? We provide useful information to discuss clinical trials with your doctor. This information is presented in clear terms.

Symptoms of P Vera are firstly fatigue, which is a strong feeling of tiredness that does not get better with rest. P Vera may cause enlargement of the spleen and feelings of early satiety, the feeling that you are full after eating only a small portion of your meal.

Other symptoms may be important and your doctor can advise you about the things to watch out for. Regular check ups are an important part of maintaining your health with P Vera.

In the next section we describe medical aspects of P Vera and support you with information about our clinical trials.

Questions & Answers about P Vera

What is your current P Vera status?

Polycythemia Vera is a rare, progressive disease in which blood cells are produced uncontrollably. It belongs to a group of blood cancers known as myeloproliferative neoplasms, or MPNs.

P Vera patients have an excess number of oxygen-carrying red blood cells and platelets, the cells that clump together to reduce bleeding. White blood cells may also be overproduced in P Vera.

What distinguishes P Vera from other MPNs, which include essential thrombocythemia and myelofibrosis, is the health impact of excess red blood cells circulating in the bloodstream.

The medical term for this is erythrocytosis.

Patients keep track of P Vera by monitoring their hematocrit value, which is the proportion of red blood cells in the bloodstream.

A normal hematocrit is 45% for men and 42% for women. A higher hematocrit is evidence of erythrocytosis, and a sign that there is an issue with your P Vera disease status.

How does erythrocytosis affect my health?

Erythrocytosis makes the blood more viscous. This means blood is not able to circulate around your body as efficiently as it should.

And that increases the risk of life-threatening blood clots. Thrombosis is the medical term for this. Thrombosis can cause strokes, breathing events and heart attack. The overproduction of white blood cells is also linked to these risks.

The cause of MPNs such as P Vera is not completely understood. We can trace the disease to several cancer-causing genetic abnormalities, or gene mutations.

One such mutation is found in the Janus kinase 2 gene, JAK2. The mutation is found on a specific part of the JAK2 gene and is called JAK2 V617F.

Approximately 95% of people with P Vera have the mutation. In most cases the mutation is acquired throughout your lifespan rather than something that you might inherit from your parents.

Normally, the JAK2 gene controls a number of important processes in your body, including the production and survival of blood cells. Disease causing genetic abnormalities such as the JAK2 V617F mutation contribute to the uncontrolled production of blood cells.

P Vera is a progressive disease. How could this affect my treatment plan?

Your healthcare team is likely to first manage P Vera with a low dose of aspirin and blood transfusions, or phlebotomy to use a medical term.

This treatment may sometimes be sufficient to manage your hematocrit for many years.

Doctors consider additional treatments when P Vera progresses and the hematocrit becomes more difficult to control. The risk of progression increases as we get older.

The chemotherapy drug Hydroxyurea (HU), called hydroxycarbamide in Europe, may be added to your treatment plan when the hematocrit is persistently above safe levels.

In some cases HU may fall short of its treatment goals. These goals are defined on medical grounds. A patient receiving HU might experience side effects that are too severe to enable further treatment.

Alternatively, a patient receiving HU may have hematocrit values that remain dangerously high. Doctors use the term resistant to describe the situation where treatment is not working as intended.



Some patients may have access to a therapy that targets selectively the JAK2 V617F mutation.

Targeted therapies are able to selectively change the disease-causing processes that result from a mutation, such as the JAK2 V617F mutation.

Clinical trials around the world seek to develop better, and better-targeted treatments for P Vera. Doctors working on these trials aim to improve the lives of P Vera patients whose disease seems to be progressing.

This is the approach that Roche is taking with the NP39761 P Vera trial.

What is the purpose of Roche’s new NP39761 P Vera trial?

The purpose of our clinical trial is to treat P Vera patients whose HU side effects are not tolerable, or who show signs of being resistant to HU treatment.

Roche’s investigational treatment is taken orally and targets specific cancer-causing processes that are disrupted by mutations to the JAK2 gene.

The investigational treatment is taken in a stable and continuous cycle starting with 5 days of treatment and followed by 3 weeks without the daily dose.

All participants in these trials will receive the Study NP39761 investigational treatment. No patients enrolled on the trial will receive a placebo as treatment.

With your permission the clinical trial team will use medically-approved surveys to track the symptoms of PV. We wish to find out the impact of the investigational treatment on your day-to-day wellbeing.

Who will pay the costs associated with being part of the trial?

Roche will cover the cost of study medication, visits, assessments and reasonable costs of travel.

What is a clinical trial and how do I participate?

Our clinical trials are conducted in hospitals by medical teams who are specialized in the treatment of P Vera.

A team of doctors, members of the general public and health authorities review each clinical trial. Formal approval by this team is needed before the clinical trial can begin.

Every trial is monitored closely by the healthcare team providing the investigational treatment and by the health authorities.

To join a trial, a medical team must carefully evaluate whether you are eligible to participate. This evaluation is made on a case-by-case basis and decided on medical grounds.

Specific medical factors are considered beyond a confirmed P Vera diagnosis. Based on these factors, some P Vera patients may not be eligible to participate in this particular trial.

The information on this website supports you and your doctor to understand our clinical trial. If you are eligible you have the option to give your consent to take part, and to receive the investigational treatment.

Share your story?

We encourage you to share tips about how to stay well, and how to spend time doing things that makes you feel on top of the situation. Join the online community of people impacted by P Vera.

The internet gives us access not only to information but also to each other

So consider sharing your story here, too.

With your permission, your messages and comments may be published here for you to share with others. Have you ever participated in a clinical trial? Do you have a tip to share? Leave a comment. Different people bring different insights!

Thank you for stopping by at this website.