NCT03635580 is a Phase 3 clinical trial of Negative control in Dwarfism, sponsored by Changchun GeneScience Pharmaceutical Co., Ltd..

Who is sponsoring NCT03635580?

NCT03635580 is sponsored by Changchun GeneScience Pharmaceutical Co., Ltd..

What drugs are being tested in NCT03635580?

Interventions in NCT03635580: Negative control.

Is NCT03635580 still recruiting?

NCT03635580 is currently status unknown. Last updated 15 August 2018.

Last reviewed 2018-08-15 · How we verify

NCT03635580

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

Phase 2 Study of Efficacy and Safety of rhGH (Jintropin®) in Pediatric Participants With ISS (Idiopathic Short Stature): a 52-week Multicenter, Open-label, Randomized, Negative Controlled Study Followed by a 52-week Open-label Period

Status unknown Phase 3 Last updated 15 August 2018

What this trial tests

Phase 3 trial testing Negative control in Dwarfism in 480 participants. Status unknown.

Timeline

11 June 2018

Primary endpoint
1 October 2021

30 October 2021

Quick facts

Lead sponsor	Changchun GeneScience Pharmaceutical Co., Ltd.
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	480
Start date	11 June 2018
Primary completion	1 October 2021
Estimated completion	30 October 2021
Sites	9 locations across China

Drugs / interventions tested

Negative control — full drug profile →

Conditions studied

Dwarfism — all drugs for Dwarfism →

Sponsor

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

Who can join

Adults 4 to 10, any sex, with Dwarfism. 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.

ΔHtSDSca (The change of height standard deviation score of chronological age before and after treatment)
Time frame: Baseline, 4,13,26,39,52,65,78,91,104 weeks after initiating treatment, 52 weeks in phase 1; 2 years in phase 2.
ΔHtSDSca was the difference of HtSDSca before and after treatment, and HtSDSca was calculated by dividing the difference between the actual height of a patient and the mean height of the population for that chronological age by the standard deviation (SD) of the height of the population for that chronological age.

Sponsor's own description

Phase 1: To evaluate the safety and efficacy of 0.05mg/kg/d of rhGH (Jintropin®) in the treatment of children with idiopathic short stature (ISS) in 52 weeks. Phase 2: To evaluate the safety and efficacy of rhGH (Jintropin®) in the treatment of children with ISS in 2 years

Publications & conference data

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

A Randomized Controlled Phase 3 Study on the Efficacy and Safety of Recombinant Human Growth Hormone in Children With Idiopathic Short Stature.
Yuan J, Fu J, Wei H, Zhang G, et al · · 2022 · cited 10× · PMID 35573994 · DOI 10.3389/fendo.2022.864908

Verify or expand the search:

Other trials of Negative control

Trials testing the same drug.

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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 NCT03635580 (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: 15 August 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/NCT03635580.

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