deltatrials
Unknown PHASE1/PHASE2 INTERVENTIONAL 3-arm NCT02453477

Gene Therapy for Transfusion Dependent Beta-thalassemia (TIGET-BTHAL)

A Phase I/II Study Evaluating Safety and Efficacy of Autologous Hematopoietic Stem Cells Genetically Modified With GLOBE Lentiviral Vector Encoding for the Human Beta-globin Gene for the Treatment of Patients Affected by Transfusion Dependent Beta-thalassemia

Sponsor: Fondazione Telethon

Updated 9 times since 2017 Last updated: Jun 26, 2019 Started: May 31, 2015 Primary completion: Aug 31, 2019 Completion: Aug 31, 2019
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT02453477, this PHASE1/PHASE2 trial focuses on Beta-Thalassemia and remains ongoing. Sponsored by Fondazione Telethon, it has been updated 9 times since 2015, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Jan 2017 – ~Mar 2018 · 14 months · monthly snapshotRecruiting~Mar 2018 – ~Jun 2018 · 3 months · monthly snapshotRecruiting~Jun 2018 – ~Jul 2019 · 13 months · monthly snapshotActive Not Recruiting~Jul 2019 – ~Jan 2021 · 18 months · monthly snapshotActive Not Recruiting~Jan 2021 – ~Oct 2021 · 9 months · monthly snapshotActive Not Recruiting~Oct 2021 – ~Jul 2024 · 33 months · monthly snapshotUnknown Status~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotUnknown~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotUnknown~Sep 2025 – present · 10 months · monthly snapshotUnknown

Change History

9 versions recorded
  1. Sep 2025 — Present [monthly]

    Unknown PHASE1/PHASE2

  2. Sep 2024 — Sep 2025 [monthly]

    Unknown PHASE1/PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Unknown PHASE1/PHASE2

    Status: Unknown StatusUnknown · Phase: PHASE1_PHASE2PHASE1/PHASE2

  4. Oct 2021 — Jul 2024 [monthly]

    Unknown Status PHASE1_PHASE2

    Status: Active Not RecruitingUnknown Status

  5. Jan 2021 — Oct 2021 [monthly]

    Active Not Recruiting PHASE1_PHASE2

Show 4 earlier versions
  1. Jul 2019 — Jan 2021 [monthly]

    Active Not Recruiting PHASE1_PHASE2

  2. Jun 2018 — Jul 2019 [monthly]

    Active Not Recruiting PHASE1_PHASE2

    Status: RecruitingActive Not Recruiting

  3. Mar 2018 — Jun 2018 [monthly]

    Recruiting PHASE1_PHASE2

  4. Jan 2017 — Mar 2018 [monthly]

    Recruiting PHASE1_PHASE2

    First recorded

May 2015

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Fondazione Telethon
  • IRCCS San Raffaele
  • Orchard Therapeutics
Data source: IRCCS San Raffaele

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations