HypoparathyroidismPhase 3NCT05387070
PaTHway CHINA TRIAL: A Trial to Investigating the Safety, Tolerability and Efficacy of TransCon PTH in Adults With Hypoparathyroidism
A Phase 3 study testing TransCon PTH in people with Hypoparathyroidism and Parathyroid Hormone Deficiency, run by Visen Pharmaceuticals (Shanghai) Co., Ltd. at 1 site in China.
Trial summary
This study is limited to conduct in China only. The primary objective is to assess the treatment effect of daily TransCon PTH on serum calcium (sCa) levels within the normal range and stopping from therapeutic doses of active vitamin D (calcitriol) or active vitamin D analogue (alfacalcidol) and calcium at 26 weeks of… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypoparathyroidism, Parathyroid Hormone Deficiency, Endocrine System Diseases
- What is being tested?
- TransCon PTH
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 1 siteChina
- Study dates
- 28 Jul 2021to 8 Jan 2026
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females, ≥18 years of age
- Subjects with postsurgical chronic HP, or auto-immune, genetic, or idiopathic HP for at least 26 weeks. Diagnosis of HP is established based on historic hypocalcemia in the setting of inappropriately low (below the ULN of local laboratory) serum PTH levels.
- Requirement for doses of SoC (e.g., calcitriol, alfacalcidol, calcium supplements) at or above a minimum threshold:
- requirement for a dose of calcitriol ≥0.5 μg/day, or alfacalcidol ≥1.0 μg/day and (elemental) calcium ≥800 mg/day (e.g., calcium citrate, calcium carbonate etc.) for at least 12 weeks prior to Screening. In addition, the dose of calcitriol, or alfacalcidol, and calcium should be stable for at least 5 weeks prior to Screening
- Optimization of supplements prior to randomization to achieve the target serum levels of:
- 25(OH) vitamin D levels of 10-100 ng/mL (25-250 nmol/L) and
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- Magnesium level in the normal range, or just below the normal range i.e.: ≥1.3 mg/dL (0.53 mmol/L) and
- Albumin-adjusted sCa level in the normal range, or just below the normal range, i.e.: 7.8-10.6 mg/dL (or 1.95-2.64 mmol/L)
- The subject demonstrates a 24-hour uCa excretion of ≥125 mg/24h (on a sample collected within 52 weeks prior to Screening or during the Screening Period)
- BMI 17- 40 kg/m2 at Screening
- If ≤25 years of age, radiological evidence of epiphyseal closure based on X-ray of non-dominant wrist and hand
- Thyroid-stimulating hormone (TSH) within normal laboratory limits within the 6 weeks prior to Visit 1; if on suppressive therapy for a history of thyroid cancer, TSH level must be ≥0.2 mIU/L
- If treated with thyroid hormone replacement therapy, the dose must have been stable for at least 5 weeks prior to Screening
- eGFR ≥30 mL/min/1.73 m2 during Screening
- Able to perform daily SC self-injections of study drug (or have a designee to perform injections) via a pre-filled injection pen
- Able and willing to provide written and signed ICF in accordance with GCP
Who cannot join
- Impaired responsiveness to PTH (pseudohypoparathyroidism) which is characterized as PTH-resistance, with elevated PTH levels in the setting of hypocalcemia
- Any disease that might affect calcium metabolism or calcium-phosphate homeostasis or PTH levels other than HP, such as active hyperthyroidism; Paget disease of bone; severe hypomagnesemia; type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus (HbA1C >9%, documented HbA1C result drawn within 12 weeks prior to Screening is acceptable); severe and chronic liver, or renal disease; Cushing syndrome; multiple myeloma; active pancreatitis; malnutrition; rickets; recent prolonged immobility; active malignancy (other than low-risk well differentiated thyroid cancer or non-melanoma skin cancer); active hyperparathyroidism; parathyroid carcinoma within 5 years prior to Screening; acromegaly;or multiple endocrine neoplasia
- High risk thyroid cancer within 2 years, requiring suppression of TSH <0.2 mIU/L
- Long term use of loop diuretics, phosphate binders (other than calcium supplements), digoxin, lithium, methotrexate, biotin >30 µg/day, or systemic corticosteroids (other than as replacement therapy)
- Use of thiazide diuretic within 4 weeks prior to the 24-hour urine collection scheduled to occur within 1 week prior to Visit 1
- Use of PTH-like drugs (whether commercially available or through participation in an investigational trial), including PTH (1-84), PTH (1-34), or other N-terminal fragments or analogs of PTH or PTH-related protein, within 4 weeks prior to Screening
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- Use of other drugs known to influence calcium and bone metabolism, such as calcitonin, fluoride tablets (>0.5 mg/day), strontium, or cinacalcet hydrochloride, within 12 weeks prior to Screening
- Use of osteoporosis therapies known to influence calcium and bone metabolism, i.e., bisphosphonate (oral or intravenous [IV]), denosumab, raloxifene, or romosozumab therapies within 2 years prior to Screening
- Non-hypocalcemic seizure disorder with a history of a seizure within 26 weeks prior to Screening
- Increased risk for osteosarcoma, such as those with Paget's disease of bone or unexplained elevations of alkaline phosphatase, hereditary disorders predisposing to osteosarcoma, or with a prior history of substantial external beam or implant radiation therapy involving the skeleton
- Pregnant or lactating women
- Male who has a female partner who intends to become pregnant or is of childbearing potential and is unwilling to use adequate contraceptive methods during the trial
- Diagnosed drug or alcohol dependence within 3 years prior to Screening
- Disease processes that adversely affect gastrointestinal absorption, including but not limited to short bowel syndrome, significant small bowel resection, gastric bypass, tropical sprue, active celiac disease, active ulcerative colitis, active Crohn's disease, gastroparesis and AIRE gene mutations with malabsorption
- Severe cardiac disease within 26 weeks prior to Screening including but not limited to congestive heart failure, myocardial infarction, severe or uncontrolled arrhythmias, bradycardia (resting heart rate <48 beats/minute, unless chronic and asymptomatic), symptomatic hypotension or systolic BP <80 mm Hg or diastolic <40 mm Hg or poorly controlled hypertension (systolic BP >165 mm Hg or diastolic >95 mm Hg). In the absence of a prior history of hypertension, an isolated BP >165/95 mm Hg in the setting of white coat hypertension/anxiety may not be exclusionary and a measurement can be repeated prior to randomization
- Cerebrovascular accident within 5 years prior to Screening
- Within 26 weeks prior to Screening: acute colic due to nephrolithiasis, or acute gout. Subjects with asymptomatic renal stones are permitted
- Participation in any other interventional trial in which receipt of investigational drug or device occurred within 8 weeks (or within 5.5 times the half-life of the investigational drug) (whichever comes first) prior to Screening
- Any disease or condition that, in the opinion of the investigator, may require treatment or make the subject unlikely to fully complete the trial, or any condition that presents undue risk from the investigational product or procedures, including treated malignancies that are likely to recur within the approximate 3.5-year duration of the trial
- Known allergy or sensitivity to PTH or any of the excipients [metacresol, mannitol, succinic acid, NaOH/(HCl)]
- Likely to be non-compliant with respect to trial conduct
- Any other reason that in the opinion of the investigator would prevent the subject from completing participation or following the trial schedule
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
About this study
Official title: PaTHway CHINA TRIAL: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial, With an Open-Label Extension, Investigating the Safety, Tolerability and Efficacy of TransCon PTH Administered Subcutaneously Daily in Adults With Hypoparathyroidism
This study is limited to conduct in China only. The primary objective is to assess the treatment effect of daily TransCon PTH on serum calcium (sCa) levels within the normal range and stopping from therapeutic doses of active vitamin D (calcitriol) or active vitamin D analogue (alfacalcidol) and calcium at 26 weeks of treatment. All subjects will start with 18 mcg of study drug and will be individually and progressively titrated to an optimal dose over a 26-week double blind period, followed by an open label extension period up to 156 weeks. TransCon PTH or placebo will be administered as a subcutaneous injection using a pre-filled injection pen. Neither trial participants nor their doctors will know who has been assigned to each group. After the 26 weeks, participants will continue in the trial as part of a long-term extension study. During the extension, all participants will receive TransCon PTH, with the dose adjusted to their individual needs.
Read the detailed description
Not Provided
- Conditions
- Hypoparathyroidism, Parathyroid Hormone Deficiency, Endocrine System Diseases, Parathyroid Diseases
- Being tested
- TransCon PTH, placebo
- Keywords
- Hypoparathyroidism, TransCon PTH, Parathyroid Hormone deficiency, PTH1-34
- Medical subject headings
- Hypoparathyroidism, Endocrine System Diseases, Parathyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TransCon PTHDrug
TransCon PTH is supplied as a solution with a concentration of 0.3 mg PTH(1-34)/mL in a single-patient-use prefilled pen intended for SC injection.
placeboDrug
Placebo is supplied as a solution containing the formulation buffer for TransCon PTH in a single-patient-use prefilled pen intended for subcutaneous injection.
| Study group | Role | What they receive |
|---|---|---|
| TransCon PTH | Experimental | TransCon PTH at a starting dose of 18 mcg delivered once daily by subcutaneous injection Receives: Drug: TransCon PTH |
| placebo | Placebo comparator | Placebo for TransCon PTH at a starting dose of 18 mcg delivered once daily by subcutaneous injection Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects who meet primary efficacy endpoint at 26 weeks of treatment
The proportion of subjects with albumin-adjusted sCa within the normal range, and independence from active vitamin D, and independence from therapeutic doses of calcium (i.e., taking calcium supplements ≤600 mg/day), and no increase in prescribed study drug within 4 weeks prior to Week 26 visit
Measured: 26 weeks
Secondary outcomes (1)
Change from baseline in HPES Symptom - Physical Domain score
Change from baseline in Hypoparathyroidism Patient Experience Scale (HPES) Symptom - Physical Domain score, a disease-specific patient reported outcome, at 26 weeks of treatment
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start28 Jul 2021
- Primary completion4 Jan 2023
- Study completion8 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoparathyroidismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomized 3:1 to receive either TransCon PTH or placebo: * TransCon PTH 18 μg/day\* , co-administered with SoC * Placebo for TransCon PTH (excipient solution) 18 μg/day, co-administered with SoC
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Visen Pharmaceuticals (Shanghai) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Weibo Xia, MD, Principal investigator, Department of endocrinology, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05387070
- Sponsor's protocol ID
- TCP-306
- Other IDs
- CTR20212047
- Status last verified
- Jan 2026
- First submitted
- 18 May 2022
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PaTHway CHINA TRIAL: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial, With an Open-Label Extension, Investigating the Safety, Tolerability and Efficacy of TransCon PTH Administered Subcutaneously Daily in Adults With Hypoparathyroidism
- ClinicalTrials.gov ID
- NCT05387070
- Acronym / sponsor ID
- TCP-306
- Conditions
- Hypoparathyroidism, Parathyroid Hormone Deficiency, Endocrine System Diseases, Parathyroid Diseases
- Keywords
- Hypoparathyroidism, TransCon PTH, Parathyroid Hormone deficiency, PTH1-34
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Visen Pharmaceuticals (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Jul 2021 (actual)
- Primary completion
- 4 Jan 2023 (actual)
- Study completion
- 8 Jan 2026 (actual)
- First posted
- 24 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is limited to conduct in China only. The primary objective is to assess the treatment effect of daily TransCon PTH on serum calcium (sCa) levels within the normal range and stopping from therapeutic doses of active vitamin D (calcitriol) or active vitamin D analogue (alfacalcidol) and calcium at 26 weeks of treatment. All subjects will start with 18 mcg of study drug and will be individually and progressively titrated to an optimal dose over a 26-week double blind period, followed by an open label extension period up to 156 weeks. TransCon PTH or placebo will be administered as a subcutaneous injection using a pre-filled injection pen. Neither trial participants nor their doctors will know who has been assigned to each group. After the 26 weeks, participants will continue in the trial as part of a long-term extension study. During the extension, all participants will receive TransCon PTH, with the dose adjusted to their individual needs.
Detailed description
Not Provided
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects will be randomized 3:1 to receive either TransCon PTH or placebo: * TransCon PTH 18 μg/day* , co-administered with SoC * Placebo for TransCon PTH (excipient solution) 18 μg/day, co-administered with SoC
| Arm | Type | Receives |
|---|---|---|
| TransCon PTH | Experimental | Drug: TransCon PTHTransCon PTH at a starting dose of 18 mcg delivered once daily by subcutaneous injection |
| placebo | Placebo comparator | Drug: placeboPlacebo for TransCon PTH at a starting dose of 18 mcg delivered once daily by subcutaneous injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Males and females, ≥18 years of age
- Subjects with postsurgical chronic HP, or auto-immune, genetic, or idiopathic HP for at least 26 weeks. Diagnosis of HP is established based on historic hypocalcemia in the setting of inappropriately low (below the ULN of local laboratory) serum PTH levels.
- Requirement for doses of SoC (e.g., calcitriol, alfacalcidol, calcium supplements) at or above a minimum threshold:
- Optimization of supplements prior to randomization to achieve the target serum levels of:
- The subject demonstrates a 24-hour uCa excretion of ≥125 mg/24h (on a sample collected within 52 weeks prior to Screening or during the Screening Period)
Key exclusion criteria (22 listed)
- Impaired responsiveness to PTH (pseudohypoparathyroidism) which is characterized as PTH-resistance, with elevated PTH levels in the setting of hypocalcemia
- Any disease that might affect calcium metabolism or calcium-phosphate homeostasis or PTH levels other than HP, such as active hyperthyroidism; Paget disease of bone; severe hypomagnesemia; type 1 diabetes mellitus or poorly controlled type 2 diabetes mellitus (HbA1C >9%, documented HbA1C result drawn within 12 weeks prior to Screening is acceptable); severe and chronic liver, or renal disease; Cushing syndrome; multiple myeloma; active pancreatitis; malnutrition; rickets; recent prolonged immobility; active malignancy (other than low-risk well differentiated thyroid cancer or non-melanoma skin cancer); active hyperparathyroidism; parathyroid carcinoma within 5 years prior to Screening; acromegaly;or multiple endocrine neoplasia
- High risk thyroid cancer within 2 years, requiring suppression of TSH <0.2 mIU/L
- Long term use of loop diuretics, phosphate binders (other than calcium supplements), digoxin, lithium, methotrexate, biotin >30 µg/day, or systemic corticosteroids (other than as replacement therapy)
- Use of thiazide diuretic within 4 weeks prior to the 24-hour urine collection scheduled to occur within 1 week prior to Visit 1
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TransCon PTHTransCon PTH is supplied as a solution with a concentration of 0.3 mg PTH(1-34)/mL in a single-patient-use prefilled pen intended for SC injection. | Drug | TransCon PTH |
| placeboPlacebo is supplied as a solution containing the formulation buffer for TransCon PTH in a single-patient-use prefilled pen intended for subcutaneous injection. | Drug | placebo |
Primary outcome
The proportion of subjects who meet primary efficacy endpoint at 26 weeks of treatment
Time frame: 26 weeks
The proportion of subjects with albumin-adjusted sCa within the normal range, and independence from active vitamin D, and independence from therapeutic doses of calcium (i.e., taking calcium supplements ≤600 mg/day), and no increase in prescribed study drug within 4 weeks prior to Week 26 visit
1 secondary outcome
Change from baseline in HPES Symptom - Physical Domain score
Time frame: 26 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weibo Xia, MD principal investigator
Department of endocrinology, Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TransCon PTH in people with Hypoparathyroidism and Parathyroid Hormone Deficiency, run by Visen Pharmaceuticals (Shanghai) Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of subjects who meet primary efficacy endpoint at 26 weeks of treatment (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.