BridgeMD
Tests treatment safety and results for Hypoparathyroidism
Official title A Cohort Study on the Safety and Efficacy of XH-02 in Treating Hypoparathyroidism
ClinicalTrials.gov ID: NCT07540286
What this study is testing
What is Single subcutaneous injection?
Single subcutaneous injection is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for hypoparathyroidism.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 90
You may be able to join if
- 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...
- Poorly controlled or intolerant to conventional treatment (calcium and vitamin D) for hypoparathyroidism;
- BMI 17-40 kg/m² (inclusive) at screening;
- If age ≤25 years, radiographic evidence of epiphyseal closure based on X-ray results of the wrist and palm of the non-dominant hand.
You likely can't join if
- 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...
- Pregnant or breastfeeding women;
- Male partners with female partners planning to become pregnant, or partners of childbearing potential who are unwilling to use adequate contraceptive...
- Patients with high-risk thyroid cancer requiring TSH suppression to \<0.2 mIU/L within 2 years, or those with a history of tumors;
See the full eligibility criteria
- 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...
- Poorly controlled or intolerant to conventional treatment (calcium and vitamin D) for hypoparathyroidism;
- BMI 17-40 kg/m² (inclusive) at screening;
- If age ≤25 years, radiographic evidence of epiphyseal closure based on X-ray results of the wrist and palm of the non-dominant hand.
- 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...
- Pregnant or breastfeeding women;
- Male partners with female partners planning to become pregnant, or partners of childbearing potential who are unwilling to use adequate contraceptive methods during the study period;
- Patients with high-risk thyroid cancer requiring TSH suppression to \<0.2 mIU/L within 2 years, or those with a history of tumors;
- Use of loop diuretics, phosphate binders (except calcium supplements), digoxin, lithium, methotrexate, biotin \>30 mcg/day, or systemic corticosteroids (except as replacement therapy);
- Use of PTH-like drugs (whether commercially available or obtained through participation in clinical trials), including PTH(1-84), PTH(1-34), or other N-terminal fragments or analogs of PTH, or PTH-related protein within...
- Participation in any other treatment trial receiving investigational drugs or devices within 8 weeks prior to screening, or still within 5.5 half-lives of the investigational drug from the trial in which they...
- Presence of uncontrolled hypertension at baseline, or a history of the following cardiovascular or cerebrovascular diseases, including: (1) unstable angina; (2) cardiac arrhythmias requiring medication or severe...
- Increased risk of osteosarcoma, such as having Paget's disease of bone or unexplained elevated alkaline phosphatase, having genetic disorders predisposing to osteosarcoma, or having a prior history of extensive external...
- Disease processes that adversely affect gastrointestinal absorption, including but not limited to short bowel syndrome, significant small bowel resection, gastric bypass surgery, tropical sprue, active celiac disease...
- Any medical or other condition that, in the investigator's judgment, may affect the conduct of the study, interfere with the study results, or increase the risk to the subject/study.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.