Study to Evaluate Efficacy and Safety of Wound Dressing Solution Containing EGF in Patients With Peptic Ulcers Bleeding (CEGP003)

• ClinicalTrials.gov Identifier: NCT03469167
• Recruitment Status: Completed
• First Posted: March 19, 2018
• Last Update Posted: March 19, 2018
• Sponsor: CGBio Inc.
• Information provided by (Responsible Party): CGBio Inc.

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Peptic Ulcer Bleeding	Device: CEGP003; Device: Injection Tx	Not Applicable

Detailed Description:

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 76 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: October 15, 2014
• Actual Primary Completion Date: November 10, 2015
• Actual Study Completion Date: January 2, 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: CEGP003	Device: CEGP003; Application of CEGP003 to peptic ulcer bleeding; Other Name: EGF
Active Comparator: Injection Tx	Device: Injection Tx; Injection of epinephrine to peptic ulcer bleeding; Other Name: epinephrine injection

Outcome Measures

Primary Outcome Measures :

1. Initial hemostasis rate [ Time Frame: Within 10 minutes after first endoscopy session ]
   Endoscopically verified cessation of bleeding for at least 10 minutes after treatment.

Secondary Outcome Measures :

1. Recurrent bleeding rate [ Time Frame: Within 72 hours ]

   If any of the following conditions are met, an endoscopy will verify for rebleeding.

   • Associated with overt signs of GI bleed (melena, and/or hematemesis)
   • Instability of Vital signs (<80/60 mmHg of blood pressure, and/or >120 beats/min of pulse)
   • Decrease in hemoglobin of at least 2 g/dl after Initial hemostasis
   • bleeding can be confirmed directly (direct visualization)
2. Time required for treatment [ Time Frame: 0 day ]
   The time from when the endoscope is inserted to when the endoscope treatment is completed.
3. Wound healing effect of peptic ulcer [ Time Frame: After 3 days (72 hours) ]
   Evaluation of Stage Classification of Gastric Ulcer by Sakita-Miwa.
4. Usability for the delivery system [ Time Frame: 0 day ]
   Evaluation of success for the delivery system

Eligibility Criteria

• Ages Eligible for Study: 20 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Sponsors and Collaborators

CGBio Inc.

Investigators

• Principal Investigator: Don Haeng Lee, MD. PhD.; Inha University Hospital
• Principal Investigator: Su Jin Hong, MD. PhD.; Soon Chun Hyang University

More Information

• Responsible Party: CGBio Inc.
• ClinicalTrials.gov Identifier: NCT03469167
• Other Study ID Numbers: CGB-01
• First Posted: March 19, 2018
• Last Update Posted: March 19, 2018
• Last Verified: March 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by CGBio Inc.:

Bleeding

Additional relevant MeSH terms:

Peptic Ulcer; Peptic Ulcer Hemorrhage; Ulcer; Hemorrhage; Pathologic Processes; Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases; Gastrointestinal Hemorrhage; Epinephrine; CEGP-003; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Adrenergic beta-Agonists; Bronchodilator Agents; Autonomic Agents; Peripheral Nervous System Agents; Anti-Asthmatic Agents; Respiratory System Agents; Mydriatics; Sympathomimetics; Vasoconstrictor Agents; Hemostatics; Coagulants