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Phase III Clinical Study of Pegylated Somatropin (PEG Somatropin) to Treat Growth Hormone Deficiency Children

NCT01495468 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 343

Last updated 2017-07-31

No results posted yet for this study

Summary

This was a multicenter, randomized, open-label, parallel controlled phase III study, compared pegylated somatropin with Jintropin AQ (somatropin liquid injection, daily administration formulation).

All the subjects were randomized into two groups, test group (PEG somatorpin) and control group (Jintropin AQ), 200 children were enrolled in test group and 100 children were enrolled in control group. Considering the case loss during the clinical study, 20% of the patients were added in each of the group, that is 240 children were in test group and 120 children were in control group, totally 360 children were enrolled in the phase III clinical study.

Whole treatment were lasted for 6 months, 4 times of follow-up were carried out at the point of baseline, 1 month, 3 month and 6 month after treatment. The evaluation of the primary time point was 3 month and 6 month after treatment, if the treatment was less than 6 months, the evaluation would be made when the treatment is finished.

Conditions

  • Growth Hormone Deficiency

Interventions

BIOLOGICAL

PEG-somatropin

drug:pegylated somatropin 0.2mg/(kg.w), once per week for 6 months drug: Jintropin AQ, 0.25mg/(kg.w), once per day for 6 months

Sponsors & Collaborators

  • Tongji Hospital

    collaborator OTHER

  • First Affiliated Hospital, Sun Yat-Sen University

    collaborator OTHER

  • Capital Medical University

    collaborator OTHER

  • Children's Hospital of Fudan University

    collaborator OTHER

  • The First Hospital of Jilin University

    collaborator OTHER

  • Changchun GeneScience Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Xiaoping Luo, Ph. D · Tongji Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2008-01-31
Completion
2008-03-31

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 NCT01495468 on ClinicalTrials.gov