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HM15912 for Short Bowel Syndrome
Phase 2
Recruiting
Research Sponsored by Hanmi Pharmaceutical Company Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Men or women, aged 18 years of age or older with Short Bowel Syndrome (SBS) resulting in intestinal failure at the time of signing the informed consent form (ICF) (or country's legal age of majority if the legal age is <18 years)
Be older than 18 years old
Must not have
History of colon cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up for 24 weeks
Awards & highlights
Summary
This trial will test a new drug for safety, how it is processed by the body, and how it affects people with a specific intestinal disorder.
Who is the study for?
Adults with Short Bowel Syndrome (SBS) who rely on parenteral nutrition or IV due to intestinal failure can join. They must have less than 200 cm of small bowel, stable for at least 6 months, and be able to consent. Those with a history of colon cancer, other cancers within the last 5 years (except certain skin cancers), or recent substance abuse cannot participate.Check my eligibility
What is being tested?
The trial is testing HM15912 against a placebo in adults with SBS-associated intestinal failure. It's randomized and double-blind, meaning neither participants nor researchers know who gets the real treatment versus placebo until after the results are collected.See study design
What are the potential side effects?
While specific side effects aren't listed here, typical ones may include reactions at injection sites, gastrointestinal symptoms, potential allergic responses, and changes in blood tests that monitor organ function.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am an adult with Short Bowel Syndrome causing intestinal failure.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had colon cancer in the past.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ for 24 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~for 24 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence of adverse events (AEs)
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: HM15912 0.5 mg/kg, 1.0mg/kg, 1.5mg/kg ActiveExperimental Treatment1 Intervention
Group II: Matching PlaceboPlacebo Group1 Intervention
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Who is running the clinical trial?
Hanmi Pharmaceutical Company LimitedLead Sponsor
191 Previous Clinical Trials
61,308 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been cancer-free for 5 years, except for certain skin or cervical cancers.I am an adult with Short Bowel Syndrome causing intestinal failure.I have short bowel syndrome, no recent surgeries, and stable IV nutrition needs.I have had colon cancer in the past.
Research Study Groups:
This trial has the following groups:- Group 1: HM15912 0.5 mg/kg, 1.0mg/kg, 1.5mg/kg Active
- Group 2: Matching Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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