A Cohort Study on the Safety and Efficacy of XH-02 in Treating Hypoparathyroidism
ConditionHypoparathyroidism
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-90
SponsorPeking Union Medical College Hospital
About this trial
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.
Eligibility criteria
Qualifiers
Age ≥18 years, both males and females eligible;
History of postoperative chronic HP or autoimmune, genetic, or idiopathic HP for at least 26 weeks. The diagnosis of HP is established based on the presence of inappropriately low serum PTH levels concurrent with hypocalcemia in the past.
Poorly controlled or intolerant to conventional treatment (calcium and vitamin D) for hypoparathyroidism;
BMI 17-40 kg/m² (inclusive) at screening;
Disqualifiers
Impaired PTH response (pseudohypoparathyroidism), characterized by PTH resistance and elevated PTH levels in the presence of hypocalcemia;
Allergic constitution, or allergy to the investigational drug or polyethylene glycol (PEG)-based drugs;
Any disease other than HP that may affect calcium metabolism, calcium-phosphorus homeostasis, or PTH levels, such as active hyperthyroidism; Paget's disease of bone; severe hypomagnesemia; type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus (HbA1C >9%; HbA1C test results from blood samples collected within 12 weeks prior to screening are acceptable); severe and chronic liver or kidney disease; Cushing's syndrome; multiple myeloma; active pancreatitis; malnutrition; rickets; recent prolonged immobilization; active malignancy (except for low-risk well-differentiated thyroid cancer or non-melanoma skin cancer); active hyperparathyroidism; parathyroid carcinoma occurring within 5 years prior to screening; acromegaly; or multiple endocrine neoplasia;
Pregnant or breastfeeding women;
Trial design
Treatments tested in this trial
- Single subcutaneous injection
- Multiple subcutaneous injection
Treatment groups
60 Participants
are divided into 10 treatment groups10
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov