deltatrials
Completed PHASE2 INTERVENTIONAL 1-arm NCT04604548

The KHENEREXT Study

A Phase IIb Open-label, Multi-centre, Extension Study to Explore the Long-term Safety and Efficacy of KH176 in Subjects With a Genetically Confirmed Mitochondrial DNA tRNALeu(UUR) m.3243A>G Mutation Who Have Completed the KHENERGYZE Study KH176-202.

Sponsor: Certara

Conditions Chronic Progressive External Ophthalmoplegia (CPEO) Maternally Inherited Diabetes and Deafness (MIDD) Mitochondrial DNA tRNALeu(UUR) m.3243A<G Mutation Mitochondrial Diseases Mitochondrial Encephalomyopathy, Lactic Acidosis and Stroke Like Episodes (MELAS)
Interventions Oral administration of 100 mg KH176 twice daily
Updated 13 times since 2020 Last updated: Mar 5, 2024 Started: Aug 9, 2021 Primary completion: Jun 1, 2023 Completion: Jun 1, 2023
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE2 clinical study on Chronic Progressive External Ophthalmoplegia (CPEO) and Maternally Inherited Diabetes and Deafness (MIDD), this trial is completed. The trial is conducted by Certara and has accumulated 13 data snapshots since 2021. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

~Nov 2020 – ~Jan 2021 · 2 months · monthly snapshot~Jan 2021 – ~Mar 2021 · 59 days · monthly snapshot~Mar 2021 – ~May 2021 · 2 months · monthly snapshot~May 2021 – ~Oct 2021 · 5 months · monthly snapshot~Oct 2021 – ~Nov 2021 · 31 days · monthly snapshot~Nov 2021 – ~Jul 2022 · 8 months · monthly snapshot~Jul 2022 – ~Oct 2022 · 3 months · monthly snapshot~Oct 2022 – ~Apr 2023 · 6 months · monthly snapshot~Apr 2023 – ~Apr 2024 · 12 months · monthly snapshot~Apr 2024 – ~Jul 2024 · 3 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshot~Sep 2025 – present · 10 months · monthly snapshot

Change History

13 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE2

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE2

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  4. Apr 2024 — Jul 2024 [monthly]

    Completed PHASE2

    Status: Active Not Recruiting → Completed

  5. Apr 2023 — Apr 2024 [monthly]

    Active Not Recruiting PHASE2

    Status: Recruiting → Active Not Recruiting

▶ Show 8 earlier versions

  1. Oct 2022 — Apr 2023 [monthly]

    Recruiting PHASE2

  2. Jul 2022 — Oct 2022 [monthly]

    Recruiting PHASE2

  3. Nov 2021 — Jul 2022 [monthly]

    Recruiting PHASE2

  4. Oct 2021 — Nov 2021 [monthly]

    Recruiting PHASE2

    Status: Not Yet Recruiting → Recruiting

  5. May 2021 — Oct 2021 [monthly]

    Not Yet Recruiting PHASE2

  6. Mar 2021 — May 2021 [monthly]

    Not Yet Recruiting PHASE2

  7. Jan 2021 — Mar 2021 [monthly]

    Not Yet Recruiting PHASE2

  8. Nov 2020 — Jan 2021 [monthly]

    Not Yet Recruiting PHASE2

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Certara
  • Julius Clinical
  • Khondrion BV
  • ProPharma Group
Data source: Khondrion BV

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

Study Locations