deltatrials
Terminated PHASE3 INTERVENTIONAL 3-arm NCT01067352

A Trial to Evaluate the Correlation Between Spontaneous Catch-up Growth, Clinical Response to Saizen (Recombinant Human Growth Hormone, r-hGH) and Gene Expression Profiling in Children Small for Gestational Age (SGA) (SAIZEN in SGA)

An Open, Multicenter, Randomized, Controlled Trial to Evaluate the Correlation Between Spontaneous Catch-up Growth, Clinical Response to Saizen (Recombinant Human Growth Hormone, r-hGH) and Gene Expression Profiling in Children Small for Gestational Age (SGA)

Sponsor: Merck KGaA, Darmstadt, Germany

Updated 7 times since 2017 Last updated: Dec 2, 2013 Started: Feb 29, 2004 Primary completion: Jul 31, 2009 Completion: Jul 31, 2009
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

This study was discontinued prematurely due to difficulty in participant recruitment.

This PHASE3 trial investigates Infant, Small for Gestational Age and is currently terminated or withdrawn. Merck KGaA, Darmstadt, Germany leads this study, which shows 7 recorded versions since 2004 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Jan 2017 – ~Jun 2018 · 17 months · monthly snapshotTerminated~Jun 2018 – ~Jan 2019 · 7 months · monthly snapshotTerminated~Jan 2019 – ~Jan 2021 · 24 months · monthly snapshotTerminated~Jan 2021 – ~Dec 2021 · 11 months · monthly snapshotTerminated~Dec 2021 – ~Jul 2024 · 31 months · monthly snapshotTerminated~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotTerminated~Sep 2024 – present · 22 months · monthly snapshotTerminated

Change History

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

    Terminated PHASE3

  2. Jul 2024 — Sep 2024 [monthly]

    Terminated PHASE3

  3. Dec 2021 — Jul 2024 [monthly]

    Terminated PHASE3

  4. Jan 2021 — Dec 2021 [monthly]

    Terminated PHASE3

  5. Jan 2019 — Jan 2021 [monthly]

    Terminated PHASE3

Show 2 earlier versions
  1. Jun 2018 — Jan 2019 [monthly]

    Terminated PHASE3

  2. Jan 2017 — Jun 2018 [monthly]

    Terminated PHASE3

    First recorded

Feb 2004

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Merck KGaA, Darmstadt, Germany
  • Merck Serono S.P.A., Italy
Data source: Merck KGaA, Darmstadt, Germany

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

Study Locations