NCT01342146 (PD) is a Phase 2 clinical trial of pegylated Somatropin in Growth Hormone Deficiency, sponsored by Changchun GeneScience Pharmaceutical Co., Ltd..

Who is sponsoring NCT01342146?

NCT01342146 is sponsored by Changchun GeneScience Pharmaceutical Co., Ltd..

What drugs are being tested in NCT01342146?

Interventions in NCT01342146: pegylated Somatropin, pegylated Somatropin, Jintropin AQ.

What condition does NCT01342146 study?

NCT01342146 studies Growth Hormone Deficiency.

Is NCT01342146 still recruiting?

NCT01342146 is currently completed. Last updated 27 July 2017.

Last reviewed 2017-07-27 · How we verify

NCT01342146: PD

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

Efficiency and Safety of Pegylated Somatropin(PEG-somatropin) in the Treatment of Children With Growth Hormone Deficiency: a Multicenter, Randomized, Open-label, Controlled Phase 2 Study

Completed Phase 2 Last updated 27 July 2017

What this trial tests

Phase 2 trial testing pegylated Somatropin in Growth Hormone Deficiency in 101 participants. Completed in 1 February 2007.

Timeline

1 May 2006

Primary endpoint
1 January 2007

1 February 2007

Quick facts

Lead sponsor	Changchun GeneScience Pharmaceutical Co., Ltd.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	101
Start date	1 May 2006
Primary completion	1 January 2007
Estimated completion	1 February 2007

Drugs / interventions tested

pegylated Somatropin — full drug profile →
pegylated Somatropin — full drug profile →
Jintropin AQ — full drug profile →

Conditions studied

Growth Hormone Deficiency — all drugs for Growth Hormone Deficiency →

Sponsor

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

Who can join

Eligibility, any sex, with Growth Hormone Deficiency. 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.

Growth velocity
Time frame: 25 weeks

Sponsor's own description

The purpose of the multicenter, randomized, open-label, controlled phase II study is to determine whether pegylated recombinant human growth hormone is effective in the treatment of children with growth hormone deficiency.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Barriers and Strategies for Oral Peptide and Protein Therapeutics Delivery: Update on Clinical Advances.
Baral KC, Choi KY. · · 2025 · cited 39× · PMID 40284395 · DOI 10.3390/pharmaceutics17040397
Long-acting growth hormone in the treatment of growth hormone deficiency in children: a systematic literature review and network meta-analysis.
Zhu J, Yuan K, Rana S, Jakki SL, et al · · 2024 · cited 14× · PMID 38580693 · DOI 10.1038/s41598-024-58616-4
Comparison between long-acting pegylated and daily recombinant human growth hormone for pediatric growth hormone deficiency a systematic review.
Zhang J, Guo S, Wang T, Chen Q. · · 2025 · cited 1× · PMID 40702077 · DOI 10.1038/s41598-025-10613-x

Verify or expand the search:

Other recruiting trials for Growth Hormone Deficiency

Currently open trials in the same condition.

NCT06542809 — Evaluation of the Propensity of Patients Under rhGH to Envision a Modification of Their Treatment Regimen Toward LAGH · NA · recruiting
NCT05681299 — Effects of GH and Lirglutide on AgRP · Phase 4 · recruiting
NCT06455956 — Use of miRNAs in Growth Hormone Deficiency (GHD) · 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 NCT01342146 (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: 27 July 2017

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/NCT01342146.

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