Actively Recruiting
Efficacy and Safety of XH02 for the Treatment of Hypoparathyroidism
Led by Peking Union Medical College Hospital · Updated on 2026-03-27
6
Participants Needed
1
Research Sites
49 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study aims to evaluate the safety and efficacy of a novel PTH replacement therapy drug in patients with hypoparathyroidism. The drug is an mRNA drug which will be translated into PTH after intravenous administration, to achieve the therapeutic effect.
CONDITIONS
Official Title
Efficacy and Safety of XH02 for the Treatment of Hypoparathyroidism
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 65 years (inclusive), male or female.
- Documented history of post-surgical chronic hypoparathyroidism or autoimmune, genetic, or idiopathic hypoparathyroidism for at least 26 weeks.
- Diagnosis confirmed by hypocalcemia with low serum PTH level.
- Poorly controlled or intolerant to conventional therapy including calcium and active vitamin D.
- Conventional therapy can be optimized during screening to achieve target serum levels of Vitamin D (10-100 ng/mL), magnesium (≥1.3 mg/dL), and albumin-corrected serum calcium within normal or slightly below normal ranges.
- Body Mass Index (BMI) between 17 and 40 kg/m² at screening.
- If aged 25 years or younger, radiological evidence of closed epiphyses by X-ray of the non-dominant hand.
You will not qualify if you...
- Impaired PTH response (pseudohypoparathyroidism) with elevated PTH and hypocalcemia.
- History of allergic predisposition or known allergy to the investigational drug or PEG-containing medications.
- Presence of other diseases affecting calcium metabolism or PTH levels such as active hyperthyroidism, Paget's disease, severe hypomagnesemia, poorly controlled diabetes, severe liver or kidney disease, Cushing's syndrome, multiple myeloma, pancreatitis, malnutrition, rickets, recent immobilization, active malignancy (except low-risk thyroid or non-melanoma skin cancer), active hyperparathyroidism, parathyroid carcinoma history within 5 years, acromegaly, or multiple endocrine neoplasia syndromes.
- Vaccination within 4 weeks prior to enrollment or planned during the study.
- Pregnant or lactating women.
- High-risk thyroid cancer requiring TSH suppression or history of malignancy.
- Need for long-term use of certain medications including 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 another interventional trial within 8 weeks prior to screening or within 5.5 half-lives of previous drug.
- Uncontrolled hypertension or history of serious cardiovascular or cerebrovascular diseases.
- Increased risk of osteosarcoma due to certain conditions or prior radiation therapy.
- Significant abnormal lab findings at screening including low neutrophil, platelet, or hemoglobin counts; elevated eosinophils; abnormal liver or kidney function.
- Any other medical condition that may affect study conduct or safety as judged by the investigator.
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
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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