An interventional study of CEGP003 and Injection Tx in Peptic Ulcer Bleeding, sponsored by CGBio Inc.. Completed. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2018-03-19.
Sponsored by CGBio Inc. · Not applicable, Interventional, and Treatment
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.
55 studies on the registry are indexed under Peptic Ulcer Hemorrhage; 6 are open to participants now.
This study's enrollment of 76 is below the median of 162 across 41 interventional studies indexed under Peptic Ulcer Hemorrhage.
Browse Peptic Ulcer Hemorrhage studies →CGBio Inc. is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: CEGP003
Device: Injection Tx
Application of CEGP003 to peptic ulcer bleeding
Also known as: EGF
Injection of epinephrine to peptic ulcer bleeding
Also known as: epinephrine injection
Initial hemostasis rate
Endoscopically verified cessation of bleeding for at least 10 minutes after treatment.
Time frame: Within 10 minutes after first endoscopy session
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)
Time frame: Within 72 hours
Time required for treatment
The time from when the endoscope is inserted to when the endoscope treatment is completed.
Time frame: 0 day
Wound healing effect of peptic ulcer
Evaluation of Stage Classification of Gastric Ulcer by Sakita-Miwa.
Time frame: After 3 days (72 hours)
Usability for the delivery system
Evaluation of success for the delivery system
Time frame: 0 day
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Ran from Oct 2014 to primary completion in Nov 2015, 12 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
CGBio Inc.