Peptic Ulcer BleedingCEGP003NCT03469167
Study to Evaluate Efficacy and Safety of Wound Dressing Solution Containing EGF in Patients With Peptic Ulcers Bleeding
A study testing CEGP003 and Injection Tx in people with Peptic Ulcer Bleeding, run by CGBio Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Peptic Ulcer Bleeding
- What is being tested?
- CEGP003 and Injection Tx
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2014to 2 Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Peptic ulcer with high-risk stigmata of recent hemorrhage (Forrest class IA, IB, IIA and IIB)
Who cannot join
- 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
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- 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
About this study
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
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.
Read the 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.
- Conditions
- Peptic Ulcer Bleeding
- Being tested
- CEGP003, Injection Tx
- Keywords
- Bleeding
- Medical subject headings
- Peptic Ulcer Hemorrhage, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CEGP003Device
Also called EGF
Application of CEGP003 to peptic ulcer bleeding
Injection TxDevice
Also called epinephrine injection
Injection of epinephrine to peptic ulcer bleeding
| Study group | Role | What they receive |
|---|---|---|
| CEGP003 | Experimental | Not described Receives: Device: CEGP003 |
| Injection Tx | Active comparator | Not described Receives: Device: Injection Tx |
What is being measured
The primary outcome is the main question the study is designed to answer.
Initial hemostasis rate
Endoscopically verified cessation of bleeding for at least 10 minutes after treatment.
Measured: Within 10 minutes after first endoscopy session
Secondary outcomes (4)
Recurrent bleeding rate
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)
Measured: Within 72 hours
Time required for treatment
The time from when the endoscope is inserted to when the endoscope treatment is completed.
Measured: 0 day
Wound healing effect of peptic ulcer
Evaluation of Stage Classification of Gastric Ulcer by Sakita-Miwa.
Measured: After 3 days (72 hours)
Usability for the delivery system
Evaluation of success for the delivery system
Measured: 0 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study start15 Oct 2014
- Primary completion10 Nov 2015
- Study completion2 Jan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peptic Ulcer BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- CGBio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Don Haeng Lee, MD. PhD., Principal investigator, Inha University HospitalSu Jin Hong, MD. PhD., Principal investigator, Soon Chun Hyang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03469167
- Sponsor's protocol ID
- CGB-01
- Acronym
- CEGP003
- Status last verified
- Mar 2018
- First submitted
- 5 Mar 2018
- Last updated
- 19 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03469167
- Acronym / sponsor ID
- CEGP003 / CGB-01
- Conditions
- Peptic Ulcer Bleeding
- Keywords
- Bleeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- CGBio Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Oct 2014 (actual)
- Primary completion
- 10 Nov 2015 (actual)
- Study completion
- 2 Jan 2017 (actual)
- First posted
- 19 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CEGP003 | Experimental | Device: CEGP003 |
| Injection Tx | Active comparator | Device: Injection Tx |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Peptic ulcer with high-risk stigmata of recent hemorrhage (Forrest class IA, IB, IIA and IIB)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CEGP003Also: EGFApplication of CEGP003 to peptic ulcer bleeding | Device | CEGP003 |
| Injection TxAlso: epinephrine injectionInjection of epinephrine to peptic ulcer bleeding | Device | Injection Tx |
Primary outcome
Initial hemostasis rate
Time frame: Within 10 minutes after first endoscopy session
Endoscopically verified cessation of bleeding for at least 10 minutes after treatment.
4 secondary outcomes
Recurrent bleeding rate
Time frame: Within 72 hours
Time required for treatment
Time frame: 0 day
Wound healing effect of peptic ulcer
Time frame: After 3 days (72 hours)
Usability for the delivery system
Time frame: 0 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Don Haeng Lee, MD. PhD. principal investigator
Inha University Hospital
Su Jin Hong, MD. PhD. principal investigator
Soon Chun Hyang University
Questions about this trial
What is this clinical trial studying?
A study testing CEGP003 and Injection Tx in people with Peptic Ulcer Bleeding, run by CGBio Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Initial hemostasis rate (time frame: Within 10 minutes after first endoscopy session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2018.