deltatrials
Terminated PHASE1 INTERVENTIONAL 5-arm NCT00410566

Safety Study of rhASM Enzyme Replacement Therapy in Adults With Acid Sphingomyelinase Deficiency (Niemann-Pick Disease)

A Phase I, Single-Center, Single Dose, Dose Escalation Study of Recombinant Human Acid Sphingomyelinase (rhASM) in Adults With Acid Sphingomyelinase Deficiency (ASMD)

Sponsor: Genzyme, a Sanofi Company

Interventions rhASM
Updated 6 times since 2017 Last updated: Mar 17, 2015 Started: Dec 31, 2006 Primary completion: Mar 31, 2009 Completion: Apr 30, 2009
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Terminated by sponsor - Single dose safety objective achieved.

A PHASE1 clinical study on Acid Sphingomyelinase Deficiency and Niemann-Pick Disease, this trial is terminated or withdrawn. The trial is conducted by Genzyme, a Sanofi Company and has accumulated 6 data snapshots since 2006. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotTerminated~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotTerminated~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotTerminated~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotTerminated~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotTerminated~Sep 2024 – present · 22 months · monthly snapshotTerminated

Change History

6 versions recorded
  1. Sep 2024 — Present [monthly]

    Terminated PHASE1

  2. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE1

  3. Jan 2021 — Jul 2024 [monthly]

    Terminated PHASE1

  4. Jun 2018 — Jan 2021 [monthly]

    Terminated PHASE1

  5. Feb 2017 — Jun 2018 [monthly]

    Terminated PHASE1

Show 1 earlier version
  1. Jan 2017 — Feb 2017 [monthly]

    Terminated PHASE1

    First recorded

Dec 2006

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Genzyme, a Sanofi Company
Data source: Sanofi

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

Study Locations