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New hope for rare blood disorder: experimental drug TGD001 enters human trials

NCT ID NCT07459114

Disease control Sponsor: TargED Biopharmaceuticals B.V. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 early-phase trial tests a new drug called TGD001 in about 70 adults with acute episodes of immune-mediated thrombotic thrombocytopenic purpura (iTTP) or related blood clotting conditions. The main goal is to check the drug's safety and how the body processes it, while also looking at whether it helps resolve clotting episodes faster. Participants receive the drug openly (no placebo) and are monitored closely for side effects and recovery.

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 70 people

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

Expected to start

May 2026

An estimate. Start dates often move.

Expected to finish

Aug 2028

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.

Key Inclusion Criteria: * 18 years old or older * Willing to sign an informed consent form * Willing to refrain from sexual intercourse or must use a contraceptive method that is highly effective for 90 days after the last dose of TGD001 * Symptomatic acute TMA episode * Accessible to follow-up Key Exclusion Criteria: * Diagnosis other than TMA, which could account for the findings of thrombocytopenia and hemolytic anemia * Diagnosis of Shiga-toxin induced HUS * Known bone marrow/graft failure * Diagnosis of ongoing severe, uncontrolled Graft versus Host Disease * Received therapeutic plasma exchange (PEX) within 7 days prior to screening * Use of an anticoagulant and/or thrombolytics * Active internal bleeding * Any major bleeding episode within the past 30 days, or diagnosis of chronic bleeding conditions * Known gastrointestinal ulcer * Severe, uncontrolled hypertension, renal impairment requiring dialysis, or liver impairment, or active infection indicated by sepsis * Life expectancy less than 3 months independent of TMA disorder * Pregnant or breastfeeding

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Conditions

The condition(s) this trial relates to.

acquired thrombotic thrombocytopenic purpura autoimmune thrombocytopenic purpura Purpura, Thrombocytopenic, Idiopathic thrombotic microangiopathy

As listed by the trial registrant

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

ITP immune-mediated thrombocytopenia Thrombotic microangiopathies

How to take part

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

  1. 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 ↗

  2. 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.

More trials for these conditions

Other studies related to the condition(s) this trial covers.