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New pill could help ITP patients who failed other treatments

NCT ID NCT06721013

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a drug called pirtobrutinib in adults with immune thrombocytopenia (ITP), a condition where the immune system destroys platelets, causing bleeding risks. The trial has two parts: first, finding safe doses, then comparing pirtobrutinib to a placebo to see if it raises platelet counts. About 68 people who have not responded to prior treatments will take the pill daily for up to 28 weeks.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
pirtobrutinib
What this could lead to
If it works, this could offer a new oral treatment option for adults with ITP who have not responded to other therapies.
What could go wrong
This is an early phase 1/2 trial with only 68 participants, so results may not apply to everyone. Side effects and lack of efficacy are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 68 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

May 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Have a diagnosis of primary ITP, defined as isolated thrombocytopenia not associated with another known disease process * Have documented history of response, defined as 2 or more platelet counts greater than or equal to 50,000/microliter (μL), to at least 1 prior line of therapy. Splenectomy is considered a line of therapy * Have relapsed or treatment-resistant primary ITP, with no available therapies known to provide clinical benefit * Have a platelet count less than 30,000/μL on 2 occasions at least 5 days apart in the 15 days before randomization * Have adequate liver, renal, and hematologic functions as defined by a table * Are willing to follow contraception requirements Exclusion Criteria: * Have a history of any thrombotic or embolic event within 12 months before screening * Had a transfusion with blood or blood products or plasmapheresis within 14 days (Phase 1) or within 28 days (Phase 2) of randomization * Have significant cardiovascular disease * Have a diagnosis or history of hematologic malignancy * Have hepatitis B virus (HBV) defined as positive for antigen of hepatitis B (HBsAg) or polymerase chain reaction (PCR) positive for HBV deoxyribonucleic acid (DNA) * Have hepatitis C virus (HCV) defined as positive for anti-HCV antibodies and PCR positive for HCV ribonucleic acid (RNA)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    45 sites in 10 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Aidport sp z o.o.

    RECRUITING

    Skorzewo, 60-185, Poland

  • Asan Medical Center

    RECRUITING

    Seoul, 05505, South Korea

  • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS

    RECRUITING

    Bologna, 40138, Italy

  • Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI)

    NOT_YET_RECRUITING

    Trieste, 34129, Italy

  • Bleeding and Clotting Disorders Institute

    NOT_YET_RECRUITING

    Peoria, Illinois, 61614, United States

  • Bristol Haematology and Oncology Centre

    RECRUITING

    Bristol, BS2 8ED, United Kingdom

  • CHU Bordeaux - Hôpital Haut-Lévêque

    RECRUITING

    Pessac, 33604, France

  • CHU Dijon - Hopital du Bocage

    RECRUITING

    Dijon, 21034, France

  • Clinica Universidad de Navarra

    RECRUITING

    Pamplona, 31008, Spain

  • Clinical Research Alliance

    RECRUITING

    Westbury, New York, 11590, United States

  • Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico

    RECRUITING

    Milan, 20122, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    RECRUITING

    Roma, 00168, Italy

  • Hammersmith Hospital

    NOT_YET_RECRUITING

    London, W12 0HS, United Kingdom

  • Haukeland University Hospital

    NOT_YET_RECRUITING

    Bergen, 5021, Norway

  • Hematology Hospital of the Chinese Academy of Medical Sciences

    NOT_YET_RECRUITING

    Tianjin, 300020, China

  • Hospital Clinic de Barcelona

    RECRUITING

    Barcelona, 08036, Spain

  • Hospital General Universitario Morales Meseguer

    RECRUITING

    Murcia, 30008, Spain

  • Hospital Universitario de Burgos

    RECRUITING

    Burgos, 09006, Spain

  • Hôpital Henri Mondor

    RECRUITING

    Créteil, 94010, France

  • Leicester Royal Infirmary

    RECRUITING

    Leicester, LE1 5WW, United Kingdom

  • MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • MICS Centrum Medyczne Torun

    RECRUITING

    Torun, 87-100, Poland

  • Mayo Clinic

    NOT_YET_RECRUITING

    Rochester, Minnesota, 55905, United States

  • MedStar Georgetown University Hospital

    RECRUITING

    Washington D.C., District of Columbia, 20007, United States

  • Nanfang Hospital of Southern Medical University

    NOT_YET_RECRUITING

    Guangzhou, 510515, China

  • OUH

    RECRUITING

    Odense C, 5000, Denmark

  • Ochsner Clinic Foundation

    RECRUITING

    New Orleans, Louisiana, 70121, United States

  • Pratia MCM Krakow

    RECRUITING

    Krakow, 30-727, Poland

  • Pratia Onkologia Katowice

    RECRUITING

    Katowice, 40-519, Poland

  • Pusan National University Hospital

    RECRUITING

    Busan, 49241, South Korea

  • Qilu Hospital of Shandong University

    NOT_YET_RECRUITING

    Jinan, 250012, China

  • Royal London Hospital

    NOT_YET_RECRUITING

    London, E1 1FR, United Kingdom

  • Seoul National University Hospital

    RECRUITING

    Seoul, 03080, South Korea

  • Severance Hospital, Yonsei University Health System

    RECRUITING

    Seoul, 03722, South Korea

  • St James's University Hospital

    RECRUITING

    Leeds, LS9 7TF, United Kingdom

  • St. Olavs Hospital Hf, Universitetssykehuset i Trondheim

    NOT_YET_RECRUITING

    Trondheim, 7030, Norway

  • Stanford University

    NOT_YET_RECRUITING

    Stanford, California, 94305-5406, United States

  • Sykehuset Ostfold, Kalnes

    NOT_YET_RECRUITING

    Grålum, 1714, Norway

  • Texas Oncology - Central South

    NOT_YET_RECRUITING

    Austin, Texas, 78758, United States

  • Texas Oncology Gulf Coast

    NOT_YET_RECRUITING

    The Woodlands, Texas, 77380, United States

  • The Catholic University of Korea, Seoul St. Mary's Hospital

    RECRUITING

    Seoul, 06591, South Korea

  • USC Norris Comprehensive Cancer Center

    RECRUITING

    Los Angeles, California, 90033, United States

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    NOT_YET_RECRUITING

    Wuhan, 430022, China

  • University of Miami Hospital and Clinics Sylvester Comprehensive Cancer Center

    NOT_YET_RECRUITING

    Miami, Florida, 33136, United States

  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego we Wroclawiu

    NOT_YET_RECRUITING

    Wroclaw, 50-367, Poland

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