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Early Access Program With MaaT013 in Steroid-refractory Acute Gastrointestinal Graft Versus Host Disease

NCT04768907 · Status: AVAILABLE · Type: EXPANDED_ACCESS

Last updated 2024-08-28

No results posted yet for this study

Summary

MaaT013 is still in clinical development phase and is not approved yet for marketing in any region. During the development program, MaaT Pharma has undertaken initial development with closely related product candidates, leading to the Phase II HERACLES study in which MaaT013 preliminary safety and efficacy were assessed in the context of steroid-resistant, gastrointestinal aGraft versus Host Disease (SR-GI-aGvHD). In addition, a pivotal Phase III study (ARES trial) is planned.

In the absence of medical options in patients with gastrointestinal acute GvHD refractory to multiple lines of treatment, this early access program has been implemented.

Conditions

  • Acute Graft Versus Host Disease in Intestine
  • Steroid Refractory GVHD

Interventions

DRUG

MaaT013

Sponsors & Collaborators

  • MaaT Pharma

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Countries

  • Austria
  • Belgium
  • Canada
  • France
  • Germany
  • Italy
  • Spain
  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04768907 on ClinicalTrials.gov