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During the first four weeks of the trial, participants were randomly assigned to one of four groups: three groups received fixed doses of TransCon PTH and one group received placebo. TransCon PTH or placebo were administered as a subcutaneous injection using a pre-filled injection pen. Neither trial participants nor their doctors know who has been assigned to each group. After the four weeks, participants continued in the trial as part of a long-term extension period. During the extension, all participants received TransCon PTH, with the dose adjusted to their individual needs. This was a global trial that was conducted in the United States, Canada, Germany, Denmark, Italy and Norway.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Double Blind: TransCon PTH 15 mcg | Experimental | TransCon PTH 15 mcg delivered once daily by subcutaneous injection |
|
| Double Blind: TransCon PTH 18 mcg | Experimental | TransCon PTH 18 mcg delivered once daily by subcutaneous injection |
|
| Double Blind: TransCon PTH 21 mcg | Experimental | TransCon PTH 21 mcg delivered once daily by subcutaneous injection |
|
| Placebo | Placebo Comparator | Placebo mimicking 15, 18, or 21 mcg of TransCon PTH delivered once daily by subcutaneous injection |
|
| Open-Label Extension Period: TransCon PTH | Experimental | Participants who completed the 4-week double-blind period, continued into the open-label extension period and received treatment with TransCon PTH up to Week 266, with up to an initial 14 weeks of TransCon PTH titration and standard of care optimization, followed by approximately 248 weeks of individualized doses of TransCon PTH (allowable dose range: 6 to 60 mcg/day). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TransCon PTH | Combination Product | TransCon PTH drug product is supplied as a clear solution containing TransCon PTH with a nominal PTH(1-34) content of 0.3 mg/mL in a pre-filled pen intended for subcutaneous injection. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy - Primary Endpoint During the Blinded Period | The percentage of subjects with albumin-adjusted serum calcium within the normal range, and spot morning fractional excretion of calcium (spot AM FECa) within normal range (≤2%) or a reduction by at least 50% from baseline, and not taking active vitamin D supplements, and taking ≤1000 mg/day of calcium supplements | Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy - Key Secondary Endpoint During the Blinded Period | The percentage of subjects with albumin-adjusted serum calcium within the normal range, and spot AM FECa within the normal range (≤2%) or a reduction by at least 50% from baseline, and not taking active vitamin D supplements, and taking ≤ 500 mg/day of calcium supplements | Week 4 |
Not provided
Inclusion Criteria:
Males and females aged ≥18 years.
Subjects with postsurgical chronic HP or auto-immune, genetic, or idiopathic HP for at least 26 weeks.
On a stable dose for at least 12 weeks (or 4 weeks if on Natpara as of September 2019) prior to Screening of:
Optimization of supplements prior to randomization to achieve the target levels of:
BMI 17-40 kg/m2 at Visit 1.
If ≤25 years of age, radiological evidence of epiphyseal closure based on x-ray of non-dominant wrist and hand.
eGFR >30 mL/min/1.73m2 during Screening.
Thyroid-stimulating hormone (TSH) within normal laboratory limits within the 12 weeks prior to Visit 1; if on suppressive therapy for thyroid cancer, TSH level must be ≥0.2 μIU/mL.
If treated with thyroid hormone replacement therapy, the dose must be stable for at least 12 weeks prior to Visit 1.
Able to perform daily subcutaneous self-injections of study drug (or have a designee perform injection) via a pre-filled injection pen.
Written, signed, informed consent of the subject.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director, MD | Ascendis Pharma A/S | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ascendis Pharma Investigational Site | Chicago | Illinois | 60637 | United States | ||
| Ascendis Pharma Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41636590 | Background | Rubin MR, Clarke BL, Hofbauer LC, Khan A, Schwarz P, Vokes T, Ahmed I, Palermo A, Cetani F, Pagotto U, Zhao C, Ominsky MS, Lai B, Ukena J, Shu AD, Rejnmark L. Palopegteriparatide for Adults with Chronic Hypoparathyroidism: Skeletal Dynamics Through 3 yr of the Phase 2 paTH Forward Trial. J Bone Miner Res. 2026 Feb 4:zjag013. doi: 10.1093/jbmr/zjag013. Online ahead of print. | |
| 41365829 |
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A total of 104 subjects were screened and 59 of these met eligibility criteria and were enrolled into the study. All participants who completed the 4-week double-blind period entered the open-label extension (OLE) period, where they received TransCon PTH.
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| ID | Title | Description |
|---|---|---|
| FG000 | Double Blind: TransCon PTH 15 mcg | TransCon PTH 15 mcg delivered once daily by subcutaneous injection TransCon PTH: TransCon PTH drug product is supplied as a clear solution containing TransCon PTH with a nominal PTH(1-34) content of 0.3 mg/mL in a pre-filled pen intended for subcutaneous injection. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Blinded Period (Weeks 0 to 4) |
|
Not provided
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 21, 2023 | May 22, 2026 |
Not provided
Double-blind, placebo controlled, parallel group with subjects randomized into 4 treatment groups (1:1:1:1): TransCon PTH 15 mcg/day, TransCon PTH 18 mcg/day, TransCon PTH 21 mcg/day, placebo
Not provided
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|
| Placebo for TransCon PTH | Combination Product | Placebo is supplied as a clear solution containing the formulation buffer for TransCon PTH in a pre-filled pen intended for subcutaneous injection. |
|
| Rochester |
| Minnesota |
| 55901 |
| United States |
| Ascendis Pharma Investigational Site | Great Neck | New York | 11021 | United States |
| Ascendis Pharma Investigational Site | New York | New York | 10032 | United States |
| Ascendis Pharma Investigational Site | Philadelphia | Pennsylvania | 19104 | United States |
| Ascendis Pharma Investigational Site | Oakville | Ontario | L6M 1M1 | Canada |
| Ascendis Pharma Investigational Site | Aalborg | 9000 | Denmark |
| Ascendis Pharma Investigational Site | Aarhus | 8200 | Denmark |
| Ascendis Pharma Investigational Site | Copenhagen | 2200 | Denmark |
| Ascendis Pharma Investigational Site | Dresden | 01307 | Germany |
| Ascendis Pharma Investigational Site | Bologna | 40138 | Italy |
| Ascendis Pharma Investigational Site | Milan | 20132 | Italy |
| Ascendis Pharma Investigational Site | Pisa | 56124 | Italy |
| Ascendis Pharma Investigational Site | Rome | 00128 | Italy |
| Ascendis Pharma Investigational Site | Oslo | 0176 | Norway |
| Background |
| Rubin M, Palermo A, Vokes T, Khan AA, Schwarz P, Cetani F, Pagotto U, Tsourdi E, Sikjaer T, Pfeiffer KM, Brod M, McLeod LD, Zhao C, Noori W, Shu AD, Smith AR. Patient-reported outcomes in palopegteriparatide-treated adults with hypoparathyroidism: PaTH Forward trial extension. J Clin Endocrinol Metab. 2026 Mar 17;111(4):945-952. doi: 10.1210/clinem/dgaf653. |
| 34347093 | Result | Khan AA, Rejnmark L, Rubin M, Schwarz P, Vokes T, Clarke B, Ahmed I, Hofbauer L, Marcocci C, Pagotto U, Palermo A, Eriksen E, Brod M, Markova D, Smith A, Pihl S, Mourya S, Karpf DB, Shu AD. PaTH Forward: A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial of TransCon PTH in Adult Hypoparathyroidism. J Clin Endocrinol Metab. 2022 Jan 1;107(1):e372-e385. doi: 10.1210/clinem/dgab577. |
| 36271471 | Derived | Khan AA, Rubin MR, Schwarz P, Vokes T, Shoback DM, Gagnon C, Palermo A, Marcocci C, Clarke BL, Abbott LG, Hofbauer LC, Kohlmeier L, Pihl S, An X, Eng WF, Smith AR, Ukena J, Sibley CT, Shu AD, Rejnmark L. Efficacy and Safety of Parathyroid Hormone Replacement With TransCon PTH in Hypoparathyroidism: 26-Week Results From the Phase 3 PaTHway Trial. J Bone Miner Res. 2023 Jan;38(1):14-25. doi: 10.1002/jbmr.4726. Epub 2022 Nov 12. |
| Double Blind: TransCon PTH 18 mcg |
TransCon PTH 18 mcg delivered once daily by subcutaneous injection TransCon PTH: TransCon PTH drug product is supplied as a clear solution containing TransCon PTH with a nominal PTH(1-34) content of 0.3 mg/mL in a pre-filled pen intended for subcutaneous injection. |
| FG002 | Double Blind: TransCon PTH 21 mcg | TransCon PTH 21 mcg delivered once daily by subcutaneous injection TransCon PTH: TransCon PTH drug product is supplied as a clear solution containing TransCon PTH with a nominal PTH(1-34) content of 0.3 mg/mL in a pre-filled pen intended for subcutaneous injection. |
| FG003 | Double Blind: Placebo | Placebo mimicking 15, 18, or 21 mcg of TransCon PTH delivered once daily by subcutaneous injection Placebo for TransCon PTH: Placebo is supplied as a clear solution containing the formulation buffer for TransCon PTH in a pre-filled pen intended for subcutaneous injection. |
| FG004 | Open-Label Extension Period: TransCon PTH | Participants who completed the 4-week double-blind period continued into the open-label extension period and received treatment with TransCon PTH up to Week 266, with up to an initial 14 weeks of TransCon PTH titration and standard of care optimization, followed by approximately 248 weeks of individualized doses of TransCon PTH (allowable dose range: 6 to 60 mcg/day). |
| COMPLETED |
|
| NOT COMPLETED |
|
| Open-Label Period (Weeks 4 to 266) |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | TransCon PTH 15 mcg | TransCon PTH 15 mcg delivered once daily by subcutaneous injection TransCon PTH: TransCon PTH drug product is supplied as a clear solution containing TransCon PTH with a nominal PTH(1-34) content of 0.3 mg/mL in a pre-filled pen intended for subcutaneous injection. |
| BG001 | TransCon PTH 18 mcg | TransCon PTH 18 mcg delivered once daily by subcutaneous injection TransCon PTH: TransCon PTH drug product is supplied as a clear solution containing TransCon PTH with a nominal PTH(1-34) content of 0.3 mg/mL in a pre-filled pen intended for subcutaneous injection. |
| BG002 | TransCon PTH 21 mcg | TransCon PTH 21 mcg delivered once daily by subcutaneous injection TransCon PTH: TransCon PTH drug product is supplied as a clear solution containing TransCon PTH with a nominal PTH(1-34) content of 0.3 mg/mL in a pre-filled pen intended for subcutaneous injection. |
| BG003 | Placebo | Placebo mimicking 15, 18, or 21 mcg of TransCon PTH delivered once daily by subcutaneous injection Placebo for TransCon PTH: Placebo is supplied as a clear solution containing the formulation buffer for TransCon PTH in a pre-filled pen intended for subcutaneous injection. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Height | Mean | Standard Deviation | cm |
| |||||||||||||||
| Weight | Mean | Standard Deviation | kg |
| |||||||||||||||
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Efficacy - Primary Endpoint During the Blinded Period | The percentage of subjects with albumin-adjusted serum calcium within the normal range, and spot morning fractional excretion of calcium (spot AM FECa) within normal range (≤2%) or a reduction by at least 50% from baseline, and not taking active vitamin D supplements, and taking ≤1000 mg/day of calcium supplements | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 4 |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Efficacy - Key Secondary Endpoint During the Blinded Period | The percentage of subjects with albumin-adjusted serum calcium within the normal range, and spot AM FECa within the normal range (≤2%) or a reduction by at least 50% from baseline, and not taking active vitamin D supplements, and taking ≤ 500 mg/day of calcium supplements | Posted | Number | 95% Confidence Interval | Percentage of participants | Week 4 |
|
From Week 0 to Week 4 for double-blind treatment period and up to Week 266 for open label extension (OLE)
Analyzed on safety analysis set that included all randomized participants who received at least one dose of trial drug and were analyzed according to actual study treatment received.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Double Blind: TransCon PTH 15 mcg | TransCon PTH 15 mcg delivered once daily by subcutaneous injection TransCon PTH: TransCon PTH drug product is supplied as a clear solution containing TransCon PTH with a nominal PTH(1-34) content of 0.3 mg/mL in a pre-filled pen intended for subcutaneous injection. | 0 | 14 | 0 | 14 | 6 | 14 |
| EG001 | Double Blind: TransCon PTH 18 mcg | TransCon PTH 18 mcg delivered once daily by subcutaneous injection TransCon PTH: TransCon PTH drug product is supplied as a clear solution containing TransCon PTH with a nominal PTH(1-34) content of 0.3 mg/mL in a pre-filled pen intended for subcutaneous injection. | 0 | 15 | 0 | 15 | 5 | 15 |
| EG002 | Double Blind: TransCon PTH 21 mcg | TransCon PTH 21 mcg delivered once daily by subcutaneous injection TransCon PTH: TransCon PTH drug product is supplied as a clear solution containing TransCon PTH with a nominal PTH(1-34) content of 0.3 mg/mL in a pre-filled pen intended for subcutaneous injection. | 0 | 15 | 0 | 15 | 7 | 15 |
| EG003 | Double Blind: Placebo | Placebo mimicking 15, 18, or 21 mcg of TransCon PTH delivered once daily by subcutaneous injection Placebo for TransCon PTH: Placebo is supplied as a clear solution containing the formulation buffer for TransCon PTH in a pre-filled pen intended for subcutaneous injection. | 0 | 15 | 0 | 15 | 6 | 15 |
| EG004 | Total TransCon PTH Period | Participants who completed the 4-week double blind treatment period in placebo and TransCon PTH groups, continued into the open-label extension period and received treatment with TransCon PTH up to Week 266. This period refers to total period of exposure to TransCon PTH. For participants randomized to TransCon PTH at enrollment, the "TransCon PTH Period" was the time from first dose of blinded TransCon PTH until final analysis in OLE period. The TransCon PTH Period for participants randomized to placebo at enrollment was the time from first exposure to TransCon PTH at the time of cross-over from placebo, until final analysis in the OLE period. | 0 | 59 | 8 | 59 | 57 | 59 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Chronic sinusitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Haemorrhage intracranial | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypokalemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Invasive ductal breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Papillary tumour of renal pelvis | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Soft tissue sarcoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.0 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Thoracic vertebral fracture | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Blood thyroid stimulating hormone decreased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Blood thyroid stimulating hormone increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Bronchiolitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Heavy menstrual bleeding | Reproductive system and breast disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Injection site erythema | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Injection site haemorrhage | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Injection site pain | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Injection site swelling | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Keratitis | Eye disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA 27.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pharyngotonsillitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Thirst | General disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Ureteral stent insertion | Surgical and medical procedures | MedDRA 27.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA 27.0 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA 27.0 | Systematic Assessment |
| |
| Weight increased | Investigations | MedDRA 27.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 27.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Ascendis Pharma | +45 61161658 | asnd_registryinquiries@ascendispharma.com |
| Prot_003.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 28, 2021 | Aug 10, 2023 | SAP_002.pdf |
Not provided
| ID | Term |
|---|---|
| D007011 | Hypoparathyroidism |
| D004700 | Endocrine System Diseases |
| D010279 | Parathyroid Diseases |
Not provided
Not provided
Not provided
| Protocol Violation |
|
| Other |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| White |
|
| Other |
|
| American Indian or Alaska Native |
|
| Black or African American |
|
| Native Hawaiian or Other Pacific Islander |
|
| Unknown |
|
| t-test, 2 sided |
| = 0.6999 |
| Superiority |
| Fisher's exact test is used to compare differences in the proportion of subjects meeting the composite primary endpoint in the TransCon PTH versus pooled placebo group | t-test, 2 sided | = 0.1394 | Superiority |
| OG003 | Placebo | Placebo mimicking 15, 18, or 21 mcg of TransCon PTH delivered once daily by subcutaneous injection Placebo for TransCon PTH: Placebo is supplied as a clear solution containing the formulation buffer for TransCon PTH in a pre-filled pen intended for subcutaneous injection. |
|
|
|