Actively Recruiting
An Cohort Study on the Safety and Efficacy of XH-02 in Treating Hypoparathyroidism
Led by Peking Union Medical College Hospital · Updated on 2026-04-20
60
Participants Needed
1
Research Sites
224 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
XH-02 is an mRNA nucleic acid drug that expresses PTH in the body following intravenous or subcutaneous injection, providing PTH replacement therapy for patients with hypoparathyroidism. Previous clinical studies have demonstrated the safety of subcutaneously administered XH-02 in several patients with hypoparathyroidism and have yielded clear efficacy results. This study aims to further validate the safety and efficacy of subcutaneously injected XH-02 in the treatment of hypoparathyroidism in a expanded cohort.
CONDITIONS
Official Title
An Cohort Study on the Safety and Efficacy of XH-02 in Treating Hypoparathyroidism
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older, both males and females eligible
- History of postoperative chronic hypoparathyroidism or autoimmune, genetic, or idiopathic hypoparathyroidism for at least 26 weeks
- Diagnosis confirmed by low serum PTH levels with low calcium in the past
- Poorly controlled or intolerant to conventional calcium and vitamin D treatment
- Body mass index between 17 and 40 kg/m² at screening
- For participants 25 years or younger, radiographic confirmation of epiphyseal closure based on X-ray of the wrist and palm of the non-dominant hand
You will not qualify if you...
- Presence of pseudohypoparathyroidism with PTH resistance and elevated PTH levels despite low calcium
- Allergies to the study drug or polyethylene glycol-based drugs
- Diseases affecting calcium metabolism or PTH levels, including active hyperthyroidism, Paget's disease, severe hypomagnesemia, poorly controlled diabetes, severe liver or kidney disease, Cushing's syndrome, multiple myeloma, pancreatitis, malnutrition, rickets, recent prolonged immobilization, active malignancy (except low-risk thyroid or non-melanoma skin cancer), active hyperparathyroidism, parathyroid carcinoma within 5 years, acromegaly, or multiple endocrine neoplasia
- Pregnant or breastfeeding women
- Male partners with female partners planning pregnancy or unwilling to use contraception during the study
- High-risk thyroid cancer needing TSH suppression or history of tumors
- Use of certain medications including loop diuretics, phosphate binders (except calcium), digoxin, lithium, methotrexate, high-dose biotin, or systemic corticosteroids (except replacement therapy)
- Use of PTH-like drugs within 4 weeks prior to screening
- Participation in other interventional trials with investigational drugs or devices within 8 weeks prior to screening
- Uncontrolled hypertension or serious cardiovascular/cerebrovascular diseases
- Increased risk of osteosarcoma due to specific bone diseases, genetic disorders, or past radiation therapy involving bone
- Gastrointestinal conditions affecting absorption
- Any medical or other conditions that may interfere with the study or increase risk to the participant
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, China, 100730
Actively Recruiting
Research Team
S
SanXi Ai, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
10
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