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Safety, Tolerability and Efficacy of TransCon hGH Weekly Versus Daily hGH in Chinese Pediatric Growth Hormone Deficiency

NCT04326374 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2020-03-30

No results posted yet for this study

Summary

This study is conducted in China only. The purpose is to demonstrate the efficacy and safety of once weekly dosing of TransCon hGH, a long-acting growth hormone product, compare to once-daily dosing of human growth hormone (hGH) after 52 weeks of treatment in prepubertal children with growth hormone deficiency (GHD).

Conditions

  • Growth Hormone Deficiency
  • Endocrine System Diseases
  • Hormones
  • Pituitary Diseases
  • Pituitary Disease, Anterior

Interventions

DRUG

TransCon hGH

Once weekly subcutaneous injection

DRUG

daily hGH

Once daily subcutaneous injection

Sponsors & Collaborators

  • Ascendis Pharma A/S

    collaborator INDUSTRY

  • Visen Pharmaceuticals (Shanghai) Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Xiaoping Luo, MD · Tongji Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-30
Primary Completion
2022-04-30
Completion
2022-04-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04326374 on ClinicalTrials.gov