Efficacy and Safety Study of rhGM-CSF Gel to Treat Deep 2nd Thickness Burn

NCT ID: NCT01785784

Last Updated: 2013-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 2510 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2012-07-31

Brief Summary

This was a multicenter, randomized, phase Ⅳ study, to investigate the extensive efficacy and safety of Recombinant Human Granulocyte/Macrophage Colony-stimulating Factor Hydro-gel for Topical Application (rhGM-CSF Gel) on deep 2nd burn.

There are two parts of the phase Ⅳstudy, the first part was a multicenter, randomized, reference controlled study, all the subjects were randomized into two groups, test group (rhGM-CSF Gel) and control group (iodophor gauze), totally 358 deep 2nd burned patients were enrolled in first part of the study, 177 cases were enrolled in test group and 181 cases were enrolled in reference control group. In the test group, after the patients were enrolled in the group, clean the wound surface regularly and wash with normal saline, spread the test drug on the wound surface, bandaging with sterilized vaseline gauze, change the drug product every two or one day according to the effusion. In the reference control group, after the patients were enrolled in the group, clean the wound surface regularly and wash with normal saline, bandaging with iodophor gauze, change the drug product every two or one day according to the effusion. Whole treatment were lasted till the wound surface was healing completely, if it is not recovered in 4 weeks, calculate and record the healing rate. The secondary part of the study was a multicenter, open study, to investigate the safety of rhGM-CSF on deep 2nd burn patients. Totally 2329 patients were enrolled in this part of the study.

Conditions

Deep Partial Thickness Burn

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

burn patients

Group Type: EXPERIMENTAL

rhGM-CSF Gel

Intervention Type: DRUG

Interventions

rhGM-CSF Gel

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• age is not less than 3 years old, any gender is ok.
• the subject who is diagnosed as deep 2nd thickness burn
• the subject who was not administrated with any other topical durg on wound surface before enrolled in the clinical study.
• the subject who sign the <informed consent>

Exclusion Criteria

• age is less than 3 years old
• the subject who participated in any other clinical trial within 3 months
• the subject who was administrated with any other topical drug on wound surface before enrolled in the clinical study
• the female subject who is in lactation or pregnancy
• the subject who are allergic to rhGM-CSF, or has the allergic history to many drug products or has the allergic disease recently
• the subject who has serious heart disease, unstable angina pectoris break out, cardiac functional insufficiency, myocardial infarction or serious general infection.
• the subject who has serious renal inadequacy, creatinine(Cr) is more than 2.5 times of the upper limit
• aspartate aminotransferase or alanine transpeptidase is more than 2.5 times of the upper limit
• the subject who use immunosuppressant

• Minimum Eligible Age: 3 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: collaborator

Beijing Children's Hospital

OTHER

Sponsor Role: collaborator

Third Military Medical University

OTHER

Sponsor Role: collaborator

Changchun GeneScience Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Liao Zh Jiang, Doctor

Role: PRINCIPAL_INVESTIGATOR

Affiliated Rui Jin Hospital, Shanghai Jiao Tong University School of Medicine

Other Identifiers

GenSci-002-CT

Identifier Type: -

Identifier Source: org_study_id