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New drug shows promise in preventing deadly blood clot relapses in japanese patients

NCT ID NCT04074187

Disease control Sponsor: Sanofi 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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested a drug called caplacizumab in 21 Japanese adults with acquired thrombotic thrombocytopenic purpura (aTTP), a rare condition causing dangerous blood clots. Participants received caplacizumab alongside standard treatments like plasma exchange and steroids. The goal was to see if the drug could prevent the disease from coming back. Early results suggest it may help control the disorder, but larger studies are needed to confirm safety and effectiveness.

What this could mean

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

Active substance
caplacizumab
What this could lead to
If successful, this could offer a new treatment option to prevent life-threatening blood clots and relapses in Japanese patients with acquired TTP.
What could go wrong
This was a small, early-phase study with only 21 participants, so results may not apply to all patients. Side effects like bleeding 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 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

21 people

The number who actually took part.

Started

Oct 2019

Finished

May 2021

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 : * Japanese participant must be 18 years or older at the time of signing the informed consent. * Participants who have a clinical diagnosis of aTTP (initial or recurrent), which includes thrombocytopenia (defined as platelet count \<100,000/µL), microangiopathic hemolytic anemia as evidenced by red blood cell fragmentation (eg, presence of schistocytes), and increased levels of LDH * Participants who require initiation of daily PE treatment and have received a maximum of 1 PE treatment prior to enrollment in the study * Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies * Capable of giving signed informed consent Exclusion criteria: * Platelet count ≥100,000/µL, * Serum creatinine level \> 2.3mg/dL in case platelet count is \> 30,000µL * Known other causes of thrombocytopenia * Congenital TTP * Clinically significant active bleeding or high risk of bleeding * Malignant arterial hypertension * Known chronic treatment with anticoagulant treatment that cannot be stopped * Participants who were previously enrolled in a clinical study with caplacizumab and received caplacizumab or for whom the assigned treatment arm is unknown * Participants currently or less than 28 days prior to enrollment in this study, enrolled in a clinical study with another investigational drug or device * Clinical condition other than that associated with TTP, with life expectancy \< 6 months, such as end-stage malignancy * Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study * Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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Conditions

The condition(s) this trial relates to.

acquired thrombotic thrombocytopenic purpura thrombotic thrombocytopenic purpura

As listed by the trial registrant

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

Thrombotic thrombocytopenic purpura

Contacts and locations

Locations

  • Investigational Site Number 3920001

    Kitakyushu-Shi, Japan

  • Investigational Site Number 3920002

    Kumamoto, Japan

  • Investigational Site Number 3920003

    Kurashiki-Shi, Japan

  • Investigational Site Number 3920005

    Maebashi, Japan

  • Investigational Site Number 3920006

    Sendai, Japan

  • Investigational Site Number 3920007

    Kashihara-shi, Japan

  • Investigational Site Number 3920009

    Iruma-Gun, Japan

  • Investigational Site Number 3920010

    Kyoto, Japan

  • Investigational Site Number 3920011

    Osaka, Japan

  • Investigational Site Number 3920013

    Kawasaki-Shi, Japan

  • Investigational Site Number 3920014

    Kanazawa, Japan

  • Investigational Site Number 3920015

    Nagoya, Japan

More trials for these conditions

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