Terminated PHASE2/PHASE3 INTERVENTIONAL 2-arm NCT02413138

Versartis Trial in Pre-pubertal Japanese Children With Growth Hormone Deficiency (GHD) to Assess Long-Acting Growth Hormone (Somavaratan, VRS-317)

A Randomized, Phase 2/3, Open-Label, Multi-center Study of the Pharmacokinetics, Pharmacodynamics, Safety and Efficacy of A Long-acting Human Growth Hormone (Somavaratan, VRS-317) in Pre-pubertal Japanese Children With Growth Hormone Deficiency (GHD)

Sponsor: Versartis Inc.

Conditions Growth Disorders Pediatric Growth Hormone Deficiency

Interventions Somavaratan (VRS-317)

Updated 11 times since 2017 Last updated: Jul 22, 2022 Started: Aug 8, 2015 Primary completion: Nov 30, 2017 Completion: Nov 30, 2017

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

The primary endpoint of non-inferiority to daily therapy in the pediatric Phase 3 study was not achieved

Other terminated trials from Versartis Inc.

More terminations from Versartis Inc.

A PHASE2/PHASE3 clinical study on Growth Disorders and Pediatric Growth Hormone Deficiency, this trial is terminated or withdrawn. The trial is conducted by Versartis Inc. and has accumulated 11 data snapshots since 2015. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

Change History

11 versions recorded

Sep 2024 — Present [monthly]

Terminated PHASE2/PHASE3
Jul 2024 — Sep 2024 [monthly]

Terminated PHASE2/PHASE3

Phase: PHASE2_PHASE3 → PHASE2/PHASE3
Sep 2022 — Jul 2024 [monthly]

Terminated PHASE2_PHASE3
Dec 2021 — Sep 2022 [monthly]

Terminated PHASE2_PHASE3
Jan 2021 — Dec 2021 [monthly]

Terminated PHASE2_PHASE3

▶ Show 6 earlier versions

Nov 2020 — Jan 2021 [monthly]

Terminated PHASE2_PHASE3
Jun 2018 — Nov 2020 [monthly]

Terminated PHASE2_PHASE3
May 2018 — Jun 2018 [monthly]

Terminated PHASE2_PHASE3
Mar 2018 — May 2018 [monthly]

Terminated PHASE2_PHASE3

Status: Active Not Recruiting → Terminated
Dec 2017 — Mar 2018 [monthly]

Active Not Recruiting PHASE2_PHASE3

Status: Recruiting → Active Not Recruiting
Jan 2017 — Dec 2017 [monthly]

Recruiting PHASE2_PHASE3

First recorded

Aug 2015

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Versartis Inc.

Data source: Aravive, Inc.

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

Study Locations

• Sapporo, Japan