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

Deep Partial Thickness Burn Clinical Trial

— rhGM-CSF  

Official title:

Phase IV Clinical Trial of rhGM-CSF Hydro-gel for Topical Application on Deep 2nd Partial Thickness Burn

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01785784
• Other study ID #: GenSci-002-CT
• Status: Completed
• Phase: Phase 4
• First received: January 28, 2013
• Last updated: February 5, 2013
• Start date: November 2010
• Est. completion date: July 2012

Study information

• Verified date: February 2013
• Source: GeneScience Pharmaceuticals Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2510
• Est. completion date: July 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Burns
• Deep Partial Thickness Burn

Intervention

Drug:
• rhGM-CSF Gel

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
GeneScience Pharmaceuticals Co., Ltd.	Beijing Children's Hospital, Shanghai Jiao Tong University School of Medicine, Third Military Medical University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Heart Rate	If the 100% healing date of the wound surface is less than 28 days, record the result until the 100% healing day.	day 0, day 2, day 4, day 6, day 8, day 10, day 12, day 14, day16, day 18, day 20, day 22, day 24, day 26, day 28	Yes
Other	Body Temperature	If the 100% healing date of the wound surface is less than 28 days, record the result until the 100% healing day.	day 0, day 2, day 4, day 6, day 8, day 10, day 12, day 14, day16, day 18, day 20, day 22, day 24, day 26, day 28	Yes
Other	Blood Pressure	If the 100% healing date of the wound surface is less than 28 days, record the result until the 100% healing day.	day 0, day 2, day 4, day 6, day 8, day 10, day 12, day 14, day16, day 18, day 20, day 22, day 24, day 26, day 28	Yes
Other	Breathing Rate	If the 100% healing date of the wound surface is less than 28 days, record the result until the 100% healing day.	day 0, day 2, day 4, day 6, day 8, day 10, day 12, day 14, day16, day 18, day 20, day 22, day 24, day 26, day 28	Yes
Other	Blood Routine	Blood routine should be tested before administration and after the last administration. If the 100% healing date of the wound surface is less than 28 days, record the result in the 100% healing day.	day 0, day 28	Yes
Other	Urine Routine	Urine routine should be tested before administration and after the last administration. If the 100% healing date of the wound surface is less than 28 days, record the result in the 100% healing day.	day 0, day 28	Yes
Other	liver Function	Liver function should be tested before administration and after the last administration. If the 100% healing date of the wound surface is less than 28 days, record the result in the 100% healing day.	day 0, day 28	Yes
Other	Renal Function	Renal function should be tested before administration and after the last administration. If the 100% healing date of the wound surface is less than 28 days, record the result in the 100% healing day.	day 0, day 28	Yes
Primary	100% healing time of the wound surface		4 weeks	No
Secondary	appearance of the wound surface	If the 100% healing date of the wound surface is less than 28 days, record the result until the 100% healing day.	day 0, day 2, day 4, day 6, day 8, day 10, day 12, day 14, day16, day 18, day 20, day 22, day 24, day 26, day 28	No
Secondary	healing rate of the wound surface	If the 100% healing date of the wound surface is less than 28 days, record the result until the 100% healing day.	Day 8, day 10, day 12, day14, day 16, day 18, day 20, day22, day 24, day26 and day 28	No