Active not recruitingPHASE3INTERVENTIONAL

A Study to Assess Efficacy, Safety, and Tolerability of P1101 in Adult Patients With PV

This study is looking at a medicine called P1101 (also known as Ropeginterferon alfa-2b-njft) for adults who have Polycythaemia Vera (PV). PV is a condition that affects the blood and can lead to serious health problems. P1101 is already approved in some countries for treating PV, and this study aims to check its effectiveness and safety with a new dosing plan. The main goals are to see if using P1101 in this way can help manage PV better, reduce symptoms, and lower the risk of complications. Researchers will carefully monitor participants to understand how well the medicine is tolerated and if it causes any side effects. This research hopes to find an improved treatment option for people living with PV.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

PharmaEssentia

Enrolment target

111

Start

26 Oct 2022

Estimated completion

31 Jul 2027

Polycythemia Vera

What is this study about?

This study is about a health condition called Polycythaemia Vera, often shortened to PV. PV is a type of blood disorder where your body makes too many red blood cells. This can make your blood thicker, increasing the risk of blood clots, bleeding, and other serious issues over time. It's a long-term condition that can significantly affect a person's life.

The research is focusing on a specific medicine called P1101, which is also known as Ropeginterferon alfa-2b-njft. This medicine has already been approved and is used in some countries to treat PV. This study is like a 'Phase 3' trial, which means it's a large, important step in checking a medicine's effectiveness and safety, particularly when used in a slightly different way or with a fine-tuned dose.

The main aim is to evaluate how well P1101 works, how safe it is, and if people can tolerate it when given with an updated dosing plan. By understanding this, doctors hope to find even better ways to manage PV, help people feel better, and reduce the chances of serious complications for those living with this condition.

Key takeaways

This study is for adults with Polycythaemia Vera (PV).
It's testing a medicine called P1101 with an updated dosing plan.
The main goals are to check how well P1101 works and if it's safe.
Participants will have regular health checks and blood tests.
Taking part is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you would need to be 18 years old or older. You also need to have been diagnosed with Polycythaemia Vera (PV) by a doctor, following specific medical guidelines. The study also checks that your liver, kidneys, and blood counts are generally healthy enough for you to take part safely.

There are also some reasons why you might not be able to join. For example, if you've had a bad reaction to similar medicines in the past, or if you had to stop using interferon alfa treatment previously because it didn't work or caused too many side effects. If you have severe long-term health conditions, have had an organ transplant, or if you are pregnant or breastfeeding, you wouldn't be able to participate. The medical team will check for any other conditions that might make taking part unsafe or affect the study results.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with Polycythaemia Vera (PV)?
Are your liver and kidney functions generally healthy?
Have you had a good reaction to similar medicines (interferon alfa) in the past?
Are you currently not pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be provided with the study medicine, P1101. You would have regular appointments with the study team, where they would carry out various assessments. These might include blood tests to check your blood cell counts, liver and kidney function, and to see how the medicine is affecting your body. You would also have physical examinations and talk about any symptoms you're experiencing or any side effects from the medication. The study team would explain the full schedule of visits and what each visit involves. This trial is expected to continue for a period, with ongoing monitoring of your health and the effects of the medicine. The total duration of your participation would be fully explained before you agree to join.

Potential risks and benefits

Taking part in a study like this might have potential benefits. You would receive the study medication, P1101, which could help manage your Polycythaemia Vera. You would also receive close medical attention and monitoring from the study team. However, there are also potential risks involved. The medication might cause side effects, which would be explained in detail by the study team. Every medicine can have side effects, and some might be serious. It's important to remember that you can stop participating in the study at any time, for any reason, without it affecting your usual medical care.

Locations (23)

Baptist MD Anderson
Verified postcode
Jacksonville, United States
Fort Wayne Medical Oncology and Hematology
Verified postcode
Fort Wayne, United States
University of Kansas Medical Center
Verified postcode
Westwood, United States
Mercy Health
Verified postcode
Paducah, United States
Tulane University Medical Center
Verified postcode
New Orleans, United States
American Oncology Partners of Maryland PA (Center for Cancer & Blood Disorders)
Verified postcode
Bethesda, United States
Washington University School of Medicine
Verified postcode
St Louis, United States
Astera HealthCare
Verified postcode
East Brunswick, United States
Mount Sinai
Verified postcode
New York, United States
Montefiore Medical Center
Verified postcode
The Bronx, United States
University of North Carolina Lineberger Comprehensive Cancer Center
Verified postcode
Chapel Hill, United States
East Carolina University
Verified postcode
Greenville, United States

Common questions

What is Polycythaemia Vera (PV)?

PV is a blood condition where your body makes too many red blood cells, making your blood thicker and increasing the risk of clots and other health issues.

What is P1101?

P1101, also known as Ropeginterferon alfa-2b-njft, is a medicine currently being studied to treat Polycythaemia Vera. It's already approved in some areas for this condition.

Why is this study happening?

Researchers want to see if using P1101 with a new, updated dosing plan is effective, safe, and well-tolerated for adults with PV, aiming to improve treatment.

Will I get the actual medicine or a dummy pill?

This study is testing a specific dosing of P1101. You would receive the active study medicine, P1101, rather than a placebo (dummy pill).

What happens if I want to stop participating?

You are free to leave the study at any time, for any reason. This decision will not affect your regular medical care.