RecruitingPHASE2INTERVENTIONAL

Safety and Efficacy Study of PF-06835375 in Primary Immune Thrombocytopenia

This study is looking at a new medicine, PF-06835375, for adults who have a blood condition called Immune Thrombocytopenia (ITP). ITP causes low numbers of tiny cells called platelets, which are important for stopping bleeding. We want to find out how safe the medicine is and if it can help increase platelet counts. The study is for people who have had ITP for at least three months and up to or over a year. Participants will receive the medicine as injections under the skin over several months, and researchers will carefully watch how their platelet counts change and if they experience any side effects. This research could help find new ways to manage ITP.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Pfizer

Enrolment target

Start

02 Feb 2022

Estimated completion

02 Aug 2028

Primary Immune Thrombocytopenia

What is this study about?

This study is investigating a new medicine named PF-06835375 for adults who have a condition called Primary Immune Thrombocytopenia, often shortened to ITP. ITP is a long-term health issue where your body's immune system mistakenly attacks and destroys its own platelets. Platelets are tiny cells in your blood that help it to clot and stop bleeding, so having too few of them can lead to bruising and bleeding problems.

The main goal of this study is to see if PF-06835375 is safe to use and if it can effectively raise platelet counts in people with ITP. We believe that this medicine might work by affecting certain immune cells, which in turn could lead to more platelets being present in the blood. The study is specifically for people who have had ITP for a while, either for a few months (known as 'persistent' ITP) or for over a year (known as 'chronic' ITP).

Participants will receive the study medicine through injections under the skin. There are different groups in the study, and each will receive a specific dose of the medicine once a month for either three or four months. Throughout this time and afterwards, doctors and nurses will closely monitor participants' health, check their platelet levels, and look for any side effects. This careful monitoring helps us understand how well the medicine works and if it's a good option for treating ITP in the future.

Key takeaways

This study is for adults (18-70) with Primary Immune Thrombocytopenia (ITP).
It's testing a new medicine called PF-06835375 to see if it's safe and increases platelet counts.
Participants will receive monthly injections under the skin for 3 or 4 months.
The study focuses on people who have had ITP for at least 3 months.
Your health and platelet levels will be closely monitored throughout the study.

Who may be eligible?

To join this study, you need to be an adult between 18 and 70 years old and have been diagnosed with Primary ITP. Your platelet count must be consistently low (below 50 x 10^9/L), and you should have had ITP for at least three months, but no longer than 12 months, or for over 12 months.

There are also some reasons why you wouldn't be able to join. For example, if you've had a significant bleeding event in the past month, or if you currently have bleeding that needs urgent medical treatment or a blood transfusion. Also, if you've had your spleen removed in the last three months, or if you plan to have it removed during the study, you would not be eligible. These rules are in place to help keep everyone in the study safe and to make sure the results are clear.

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 between 18 and 70 years old?
Have you been diagnosed with Primary ITP?
Is your platelet count consistently low (below 50,000)?
Have you had ITP for at least 3 months, or for over a year?
Have you *not* had any severe bleeding in the last month that needed treatment?
Have you *not* had your spleen removed in the last 3 months, or plan to have it removed soon?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive the study medicine, PF-06835375, as injections under your skin. Depending on which group you are in, you will get these injections once a month for either three or four months. During your participation, you will have regular visits to the clinic where doctors and nurses will monitor your health, check your platelet counts through blood tests, and ask about any side effects you might be experiencing. They will also do other assessments to ensure your safety and track how the medicine is working. The total study duration, including the treatment period and follow-up, will be explained by the study team, but the treatment itself lasts approximately 3 to 4 months.

Potential risks and benefits

Taking part in this study might offer a potential benefit if the new medicine helps increase your platelet count and improves your ITP symptoms. However, like all medicines, PF-06835375 may have side effects, which the study team will discuss with you in detail. There is always a risk that the medicine might not work for you, or that you could experience side effects. Your safety and well-being are the top priority. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (31)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

East Carolina University
Verified postcode
Greenville, United States· Recruiting
Liverpool Hospital
Verified postcode
Liverpool, Australia· Recruiting
South West Radiology
Verified postcode
Liverpool, Australia· Recruiting
Slade Pharmacy
Verified postcode
Mount Kuring-Gai, Australia· Recruiting
Calvary Mater Newcastle
Verified postcode
Waratah, Australia· Recruiting
Flinders Medical Centre
Verified postcode
Bedford Park, Australia· Recruiting
ICON Cancer Centre - Kurralta Park
Verified postcode
Kurralta Park, Australia· Recruiting
The Alfred Hospital
Verified postcode
Melbourne, Australia· Recruiting
Royal Perth Hospital
Verified postcode
Perth, Australia· Recruiting
Unity Health Toronto, St. Michael's Hospital
Verified postcode
Toronto, Canada· Recruiting
McGill University Health Centre
Verified postcode
Montreal, Canada· Recruiting
Fakultni nemocnice Hradec Kralove
Verified postcode
Hradec Králové, Czechia· Recruiting

Common questions

What is ITP?

ITP stands for Immune Thrombocytopenia. It's a condition where your body's immune system mistakenly attacks and destroys its own platelets, which are cells that help your blood clot.

What is a 'Phase 2' study?

A Phase 2 study is a stage of clinical research where a new medicine is tested on a larger group of people to see if it works and to check for any side effects before it can be studied further.

How will the medicine be given?

The study medicine, PF-06835375, will be given as injections under the skin, usually once a month for a few months.

Will I know if I'm getting the real medicine?

This study is 'open-label,' which means both you and the study team will know that you are receiving the study medicine, PF-06835375.

How long does the treatment last?

The treatment period for this study will last for either three or four months, depending on the dose group you are in.

How to find out more

Pfizer CT.gov Call Center

ClinicalTrials.gov_Inquiries@pfizer.com 1-800-718-1021 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.