Presentation of Hypoparathyroidism: Etiologies and Clinical Features.
Dolores M Shoback, John P Bilezikian, Aline G Costa...
https://pubmed.ncbi.nlm.nih.gov/26943721Actively Recruiting
Phase 2
Age: 18Years - 90Years
All Genders
ID07540286
An Expanded Cohort Study on the Safety and Efficacy of mRNA Nucleic Acid Drug XH-02 in Treating Adult Hypoparathyroidism
Led by Peking Union Medical College Hospital · Updated on 2026-05-18
60
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of XH-02, an mRNA nucleic acid drug that produces parathyroid hormone (PTH) in the body, to treat adults with hypoparathyroidism. This condition involves low PTH levels leading to low calcium in the blood. Previous studies have shown that subcutaneous injection of XH-02 is safe and effective, and this expanded phase 2 study aims to confirm these findings in a larger group of patients. Participants will receive different doses of XH-02 by subcutaneous injection. Some will get a single dose ranging from 40 to 160 micrograms, while others will receive multiple doses of 40 to 160 micrograms daily or every other day for a total of five doses. The study includes several groups receiving these different dosing regimens to assess safety and treatment response. Throughout the study, participants will undergo various blood and urine tests to measure PTH levels, calcium, phosphorus, magnesium, vitamin D, and other markers. Safety is monitored by recording adverse events from the first dose up to 30 days for non-serious events and 3 months for serious events. The study will follow participants for these assessments to evaluate both safety and how well the drug works over time.
CONDITIONS
Brief Title
A Cohort Study on the Safety and Efficacy of XH-02 in Treating Hypoparathyroidism
Who Can Participate
Age: 18Years - 90Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older, 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 hypocalcemia
- 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 evidence of epiphyseal closure is required
You will not qualify if you...
- Pseudohypoparathyroidism with PTH resistance and elevated PTH levels
- Allergy to the investigational drug or polyethylene glycol (PEG)-based drugs
- Diseases affecting calcium metabolism or PTH levels, including active hyperthyroidism, Paget's disease, severe hypomagnesemia, diabetes with poor control, severe liver/kidney disease, Cushing's syndrome, multiple myeloma, active pancreatitis, malnutrition, rickets, recent immobilization, active malignancy except low-risk thyroid or skin cancer, active hyperparathyroidism, parathyroid carcinoma within 5 years, acromegaly, or multiple endocrine neoplasia
- Pregnant or breastfeeding women
- Male partners of women planning pregnancy or partners unwilling to use contraception
- 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/devices within 8 weeks prior
- Uncontrolled hypertension or serious cardiovascular/cerebrovascular diseases
- Increased risk of osteosarcoma due to conditions or prior radiation
- Diseases causing poor gastrointestinal absorption
- Any condition that may affect study conduct or increase risk according to investigator judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Up to 9 days (single dose or 5 doses every other day)
Participants receive XH-02 through subcutaneous injections as part of the treatment. This includes either a single injection or multiple injections given daily or every other day for a total of 5 doses.
1 to 5 visits depending on dosing schedule (in-person)
Follow-up
Duration - 30 days to 3 months after the last dose
Participants are monitored for safety and efficacy after treatment, including assessment of adverse events and various laboratory measurements.
Multiple visits for assessments up to 3 months post-treatment (in-person)
Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, China, 100730
Actively Recruiting
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Research Team
S
SanXi Ai, Doctor
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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Published Research Related To This Trial
Evaluation and Management of Hypoparathyroidism Summary Statement and Guidelines from the Second International Workshop.
Aliya A Khan, John P Bilezikian, Maria Luisa Brandi...
https://pubmed.ncbi.nlm.nih.gov/36054621Renal complications in patients with chronic hypoparathyroidism on conventional therapy: a systematic literature review : Renal disease in chronic hypoparathyroidism.
Elvira O Gosmanova, Pascal Houillier, Lars Rejnmark...
https://pubmed.ncbi.nlm.nih.gov/33599907Risk of Chronic Kidney Disease and Estimated Glomerular Filtration Rate Decline in Patients with Chronic Hypoparathyroidism: A Retrospective Cohort Study.
Elvira O Gosmanova, Kristina Chen, Lars Rejnmark...
https://pubmed.ncbi.nlm.nih.gov/33687651Association of Calcium and Phosphate Levels with Incident Chronic Kidney Disease in Patients with Hypoparathyroidism: A Retrospective Case-Control Study.
Elvira O Gosmanova, Olulade Ayodele, Kristina Chen...
https://pubmed.ncbi.nlm.nih.gov/36389126A Randomized Double-Blind Placebo-Controlled First-In-Human Phase 1 Trial of TransCon PTH in Healthy Adults.
David B Karpf, Susanne Pihl, Sanchita Mourya...
https://pubmed.ncbi.nlm.nih.gov/32212275Efficacy and Safety of Parathyroid Hormone Replacement With TransCon PTH in Hypoparathyroidism: 26-Week Results From the Phase 3 PaTHway Trial.
Aliya A Khan, Mishaela R Rubin, Peter Schwarz...
https://pubmed.ncbi.nlm.nih.gov/36271471Standards of care for hypoparathyroidism in adults: a Canadian and International Consensus.
Aliya A Khan, Christian A Koch, Stan Van Uum...
https://pubmed.ncbi.nlm.nih.gov/30540559Five-year Estimated Glomerular Filtration Rate in Patients With Hypoparathyroidism Treated With and Without rhPTH(1-84).
Kristina S Chen, Elvira O Gosmanova, Gary C Curhan...
https://pubmed.ncbi.nlm.nih.gov/32738041The risk of chronic kidney disease development in adult patients with chronic hypoparathyroidism treated with rhPTH(1-84): A retrospective cohort study.
Lars Rejnmark, Olulade Ayodele, Angela Lax...
https://pubmed.ncbi.nlm.nih.gov/35974422