Who is sponsoring NCT03554031?

NCT03554031 is sponsored by Changchun GeneScience Pharmaceutical Co., Ltd..

What drugs are being tested in NCT03554031?

Interventions in NCT03554031: Recombinant Human Growth Hormone (rhGH) Injection.

What condition does NCT03554031 study?

NCT03554031 studies Prader-Willi Syndrome.

Is NCT03554031 still recruiting?

NCT03554031 is currently status unknown. Last updated 30 May 2018.

Last reviewed 2018-05-30 · How we verify

NCT03554031

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Single Arm, Multicenter Phase III Clinical Trial to Evaluate the Efficacy and Safety of Recombinant Human Growth Hormone Injection in Patients With Prader-Willi Syndrome

Status unknown Phase 3 Last updated 30 May 2018

What this trial tests

Phase 3 trial testing Recombinant Human Growth Hormone (rhGH) Injection in Prader-Willi Syndrome in 30 participants. Status unknown.

Timeline

14 April 2018

Primary endpoint
1 January 2020

1 January 2020

Quick facts

Lead sponsor	Changchun GeneScience Pharmaceutical Co., Ltd.
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	14 April 2018
Primary completion	1 January 2020
Estimated completion	1 January 2020
Sites	6 locations across China

Drugs / interventions tested

Recombinant Human Growth Hormone (rhGH) Injection — full drug profile →

Conditions studied

Prader-Willi Syndrome — all drugs for Prader-Willi Syndrome →

Sponsor

Changchun GeneScience Pharmaceutical Co., Ltd. — full company profile →

Who can join

Adults 1 Month to 5, any sex, with Prader-Willi Syndrome. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

The change of the total motor quotient calculated by Peabody Developmental Motor Scale before and after treatment
Time frame: Baseline, 26 weeks, 52 weeks

Sponsor's own description

To evaluate the effectiveness of rhGH (Recombinant human growth hormone) injection for improving motor development in patients with PWS.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Early recombinant human growth hormone treatment improves mental development and alleviates deterioration of motor function in infants and young children with Prader-Willi syndrome.
Cheng RQ, Ying YQ, Qiu ZQ, Fu JF, et al · · 2023 · cited 12× · PMID 36564648 · DOI 10.1007/s12519-022-00653-y

Verify or expand the search:

Other trials of Recombinant Human Growth Hormone (rhGH) Injection

Trials testing the same drug.

NCT07481656 — Effects of Recombinant Human Growth Hormone in Elderly Patients With Moderate to Severe Acute Brain Injury (GH-ABI-RCT) · Phase 4 · not yet recruiting

Other recruiting trials for Prader-Willi Syndrome

Currently open trials in the same condition.

NCT06877715 — Autistic Symptomatology and Sensory Profile in Children With Prader-Willi Syndrome · recruiting
NCT06772597 — A Study of Setmelanotide in Patients With Prader-Willi Syndrome · Phase 2 · active not recruiting
NCT06573723 — Institutional Registry of Rare Diseases · recruiting
NCT06239116 — A Study of RM-718 in Healthy Subjects and Patients With MC4R Pathway Impairment · Phase 1, PHASE2 · recruiting
NCT06144645 — A Clinical Evaluation of Non-Invasive Vagus Nerve Stimulation for Temper Outbursts in People With PWS · Phase 3 · active not recruiting

Other Changchun GeneScience Pharmaceutical Co., Ltd. trials

Trials by the same sponsor.

NCT07534176 — To Evaluate the Impact of Smoking on PK After Single-dose Oral Administration of GS1-144 Tablets . · Phase 1 · not yet recruiting
NCT07476586 — A Study to Evaluate the Safety, Tolerability, Pharmacokinetics of GenSci161 in Healthy Adult Participants · Phase 1 · not yet recruiting
NCT07491289 — GS1-144 in Participants With Hepatic Impairment and Healthy Female · Phase 1 · not yet recruiting
NCT07537231 — A Clinical Study to Evaluate the Absorption, Metabolism, and Excretion of Oral [14C]GS1-144 in Healthy Postmenopausal Fe · Phase 1 · not yet recruiting
NCT07366866 — A Study of Safety, Tolerability, PK, and PD of Subcutaneous GenSci136 in Healthy Adults. · Phase 1 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03554031 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Changchun GeneScience Pharmaceutical Co., Ltd.
Last refreshed: 30 May 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03554031.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing