Study to Evaluate Efficacy and Safety of Wound Dressing Solution Containing EGF in Patients With Peptic Ulcers Bleeding

Clinical Study to Evaluate Efficacy and Safety of "CEGP003(Wound Dressing Solution Containing EGF)" for Achieving Hemostasis and Protecting Ulcer in Patients With Acute Peptic Ulcer Bleeding: A Prospective, Randomized Trial

This is a prospective, single-blinded, randomized study to evaluate the efficacy and safety of CEGP003 in patients with acute peptic ulcers bleeding, compared to endoscopic epinephrine injection therapy.

CEGP003 is wound dressing solution containing Hydroxyethyl-cellulose and EGF. Epidermal growth factor (EGF) stimulates cell growth and differentiation by binding to its receptor, which can enhance wound healing and regeneration of new tissue, finally may provide a new option in treating a peptic ulcers bleeding.

Inclusion Criteria:

• Peptic ulcer with high-risk stigmata of recent hemorrhage (Forrest class IA, IB, IIA and IIB)

Exclusion Criteria:

• Subjects who have a history of malignant tumor in upper gastro-intestinal site
• Subjects with platelet and coagulation dysfunction (PLT < 50E9/L, INR > 2)
• Subjects that have taken anticoagulant drugs or non-steroidal anti-inflammatory drugs within 72 hours after the treatment
• Subjects with one or more bleeding sources
• Subjects who are pregnant or breast-feeding
• Subject who are allergic or have a hypersensitive reaction to Hydroxyethyl-cellulose or EGF
• Subjects who have undergone endoscopically therapies within the last 7 days
• Subjects who are considered not suitable for the study by significant disease
• Subjects who are not able to comply with the study requirements
• Subjects who are currently enrolled in another clinical study which can impact the study within 30 days of screening
• Subjects who are considered not suitable for the study by the investigator