Actively Recruiting
Safety Evaluation of Gene Therapy Drug in the Treatment of Primary Hypertriglyceridemic Patients With Recurrent Pancreatitis
Led by GeneCradle Inc · Updated on 2025-07-03
7
Participants Needed
1
Research Sites
219 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study will evaluate safety and tolerance of intravenous delivery of GC304 gene therapy drug as a treatment of primary hypertriglyceridemic patients with previous onset of acute pancreatitis.
CONDITIONS
Official Title
Safety Evaluation of Gene Therapy Drug in the Treatment of Primary Hypertriglyceridemic Patients With Recurrent Pancreatitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with primary hypertriglyceridemia poorly managed by treatment and diet, with one or two episodes of acute pancreatitis within 5 years
- Fasting plasma triglycerides above 5.65 mmol/L after low-fat diet intake
- Homozygous or heterozygous mutations in GPIHBP1 or LPL genes confirmed by genetic screening
- Patients of reproductive age agree to use effective contraception from screening until 6 months after the trial
- Able to understand and follow study requirements, including low-fat diet and providing biological samples
- Willing to participate voluntarily and provide informed consent
You will not qualify if you...
- Allergy to any trial drug ingredients or having diseases that prevent treatment
- Active bacterial, fungal, viral, or other infections
- Intolerance to immunosuppressive drugs or steroids
- Serious or uncontrolled illnesses including ongoing abdominal pain, cancer, autoimmune diseases, epilepsy, mental illness, heart diseases, poorly controlled diabetes, or high blood pressure despite treatment
- Abnormal lab tests exceeding specified limits for liver enzymes, bilirubin, creatinine, phosphatase kinase, or low kidney function
- Positive tests for hepatitis B, hepatitis C, HIV, syphilis, or pregnancy
- High levels of AAV5 neutralizing antibodies
- Recent use of other clinical trial drugs or planned participation in other trials
- Recent blood donation or transfusions
- Major surgery within 3 months prior to screening
- High alcohol consumption recently or inability to abstain during the trial
- Pregnancy, breastfeeding, or inability to use effective contraception
- Poor compliance or inability to complete the study as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking Union Medical College
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
G
GeneCradle, Inc. China
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here