Health TrialsbyHealthPanel

TGD001 Treatment in Thrombotic Microangiopathies

ConditionsThrombotic MicroangiopathiesITP 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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • TGD001

    Drug

    IV bolus administration

Treatment groups

70 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: Dose Level 1Experimental treatment 1 intervention
Group B: Dose Level 2Experimental treatment 1 intervention
Group C: Dose Level 3Experimental treatment 1 intervention
Group D: Dose Level 4Experimental treatment 1 intervention
Group E: Basket 1Experimental treatment 1 intervention
Group F: Basket 2Experimental treatment 1 intervention
Group G: Basket 3Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of treatment emergent adverse events (safety and tolerability of TGD001)

Measurement of treatment emergent adverse events using the Common Terminology Criteria for Adverse Events (CTCAE) criteria

Time frame
90 days

Secondary outcomes

1

Change from baseline in lactate dehydrogenase (LDH) and other tissue damage markers

Measurement of LDH and other tissue damage markers

Time frame
90 days
2

Change from baseline in platelet count

Measurements of platelet count from baseline

Time frame
90 days
3

Time to resolution of the thrombotic episode

Measurement of platelet count and LDH levels

Time frame
90 days
4

Change from baseline of disease-related signs and symptoms using CTCAE v5.0 criteria

Assessment or improvement of disease related signs and symptoms

Time frame
90 days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

TargED Biopharmaceuticals B.V.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: