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An Open Label, Multi-centre, Phase I/II Dose Escalation Trial of a Recombinant Adeno-associated Virus Vector (AAV2/5-hRKp.RPGR) for Gene Therapy of Adults and Children With X-linked Retinitis Pigmentosa Owing to Defects in Retinitis Pigmentosa GTPase Regulator (RPGR)

Trial Profile

An Open Label, Multi-centre, Phase I/II Dose Escalation Trial of a Recombinant Adeno-associated Virus Vector (AAV2/5-hRKp.RPGR) for Gene Therapy of Adults and Children With X-linked Retinitis Pigmentosa Owing to Defects in Retinitis Pigmentosa GTPase Regulator (RPGR)

Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 08 Aug 2018

At a glance

  • Drugs A-004 (Primary)
  • Indications Retinitis pigmentosa
  • Focus Adverse reactions; First in man
  • Sponsors MeiraGTx
  • Most Recent Events

    • 31 Aug 2018 Biomarkers information updated
    • 08 Aug 2018 According to a MeiraGTx media release, the company has completed the dosing of the second dose escalation cohort. Till now 7 adult patients are treated. IDMC ( independent data monitoring committee) has recommended to procced with the last and the higher dose cohort and anticipates completing dosing in this final adult cohort in Q3 2018. The company expects to initiate dosing in the pediatric extension phase of the study in Q4 2018.
    • 29 Aug 2017 New trial record
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