TGD001 Treatment in Thrombotic Microangiopathies

ConditionsThrombotic Microangiopathies ITP Immune-Mediated Thrombocytopenia

Trial statusNot yet recruiting

Trial phasePhase 1, Phase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorTargED Biopharmaceuticals B.V.

About this trial

This is a Phase 1/2, prospective, adaptive design trial of TGD001 in participants with suspicion or clinical diagnosis of acute immune thrombotic thrombocytopenic purpura (iTTP) episodes and participants with suspicion or clinical diagnosis of an acute Thrombotic Microangiopathy (TMA) episode. The trial is an open-label, dose escalation and expansion basket trial.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

TGD001

Treatment groups

70 Participants

are divided into 7 treatment groups

Treatment groups

See each treatment group below.

Locations

This trial has no locations

Sponsors and collaborators

TargED Biopharmaceuticals B.V.

Lead sponsor

Source ClinicalTrials.gov