重组人甲状旁腺素(1-84)(重庆科润生物医药研发有限公司)(Parathyroid hormone 1-84(Chongqing Kerun Biologic Pharmaceutical Development Co Ltd))

概要

基本信息

药物类型

重组多肽、生物类似药

别名

Parathyroid hormone (1-84)(Kerun Biopharmaceutical)、Recombinant human parathyroid hormone (PTH) 1-84(Kerun)、rhPTH (1-84)(Kerun)

靶点

PTH1R

作用机制

PTH1R激动剂(甲状旁腺激素受体激动剂)、骨生成刺激剂、甲状旁腺激素替代物

治疗领域

在研适应症

非在研适应症

原研机构

在研机构

非在研机构

最高研发阶段临床2期

首次获批日期-

最高研发阶段(中国)临床2期

特殊审评-

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关联

6

项与重组人甲状旁腺素(1-84)(重庆科润生物医药研发有限公司) 相关的临床试验

CTR20180455 / Completed临床1期

注射用重组人甲状旁腺素（1-84）在健康受试者中进行的开放、单中心耐受性及药代动力学研究

1.评价健康人对注射用重组人甲状旁腺素（1-84）单次给药和多次给药的安全性和耐受性； 2.观察注射用重组人甲状旁腺素（1-84）单次给药和多次给药后，健康人体内的药代动力学特征。

开始日期2018-04-16

申办/合作机构

重庆科润生物医药研发有限公司

CTR20160847 / Completed临床3期

注射用重组人甲状旁腺素（1-84）治疗绝经后妇女骨质疏松的随机、开放、阳性药对照、多中心临床研究

进一步验证注射用重组人甲状旁腺素（1-84）治疗绝经后妇女骨质疏松的安全性和有效性

开始日期2016-11-14

申办/合作机构

重庆科润生物医药研发有限公司

JPRN-UMIN000014074 / RecruitingN/AIIT

The effect of improving the bone density at the surrounding total knee arthroplasty by Human Parathyroid Hormone (PTH) - The effect of improving the bone density at the surrounding TKA by PTH

开始日期2014-04-04

申办/合作机构-

100 项与重组人甲状旁腺素(1-84)(重庆科润生物医药研发有限公司) 相关的临床结果

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100 项与重组人甲状旁腺素(1-84)(重庆科润生物医药研发有限公司) 相关的转化医学

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100 项与重组人甲状旁腺素(1-84)(重庆科润生物医药研发有限公司) 相关的专利（医药）

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124

项与重组人甲状旁腺素(1-84)(重庆科润生物医药研发有限公司) 相关的文献（医药）

2024-03-01·Endocrine Practice

Extended Treatment With Recombinant Human Parathyroid Hormone (1-84) in Adult Patients With Chronic Hypoparathyroidism

Article

作者: Yin, Shaoming ; Ayodele, Olulade ; Tokareva, Elena ; Cusano, Natalie ; Finkelman, Richard D ; Rubin, Mishaela R

OBJECTIVERecombinant human parathyroid hormone (1-84) (rhPTH[1-84]) is efficacious in patients with hypoparathyroidism but additional data supporting its prolonged use are needed. We evaluated whether efficacy, safety, and tolerability are maintained during long-term rhPTH(1-84) treatment of patients with chronic hypoparathyroidism.METHODSThis was a phase 4, single-center, open-label, single-arm, 3-year extension (NCT02910466) of the phase 3 Hypo Extended (HEXT) study (NCT01199614). Patients self-administered rhPTH(1-84) once daily by subcutaneous injection, with doses individualized based on clinical parameters. Albumin-adjusted serum calcium levels (primary outcome measure), other disease biomarkers, health-related quality of life, and safety of rhPTH(1-84) were assessed using descriptive statistics.RESULTSAll patients (n = 39) had been exposed to rhPTH(1-84) (mean exposure [SD] 8.5 [3.5] years) before the start of the study, resulting in a mean exposure of 10.8 years including the present study. Mean patient age was 51.9 years, 79.5% were female, and 97.4% were White. Mean albumin-adjusted serum calcium concentrations were within the target range, and mean serum phosphate, serum calcium-phosphate product, and 24-hour urinary calcium excretion levels were within reference ranges at end of treatment. Mean doses of supplemental calcium and active vitamin D were maintained throughout the study. Bone turnover marker levels were maintained from baseline to end of treatment. No clinically relevant changes in bone mineral density were observed. Patient-reported health-related quality-of-life scores were generally maintained throughout the study. Four adverse events were considered treatment related and no new safety signals were identified.CONCLUSIONThe effects of rhPTH(1-84) on biochemical, skeletal, and health-related quality-of-life parameters did not wane with extended use.

2024-03-01·JBMR Plus

Open-label extension of a randomized trial investigating safety and efficacy of rhPTH(1–84) in hypoparathyroidism

作者: Abbott, Lisa G ; Khan, Aliya A ; Yin, Shaoming ; Rejnmark, Lars ; Finkelman, Richard D ; Gagnon, Claudia ; Takacs, Istvan ; Ing, Steven W ; Ahmed, Intekhab ; Ayodele, Olulade ; Mezosi, Emese

Abstract Hypoparathyroidism (HypoPT) is a rare disease, often inadequately controlled by conventional treatment. PARALLAX was a mandatory post-marketing trial assessing pharmacokinetics and pharmacodynamics of different dosing regimens of recombinant human parathyroid hormone 1–84 (rhPTH[1–84]) for treating HypoPT. The present study (NCT03364738) was a phase 4, 1-yr open-label extension of PARALLAX. Patients received only 2 doses of rhPTH(1–84) in PARALLAX and were considered treatment-naive at the start of the current study. rhPTH(1–84) was initiated at 50 μg once daily, with doses adjusted based on albumin-corrected serum calcium levels. Albumin-corrected serum calcium (primary outcome measure), health-related quality of life (HRQoL), adverse events, and healthcare resource utilization (HCRU) were assessed. The mean age of the 22 patients included was 50.0 yr; 81.8% were women, and 90.9% were White. By the end of treatment (EOT), 95.5% of patients had albumin-corrected serum calcium values in the protocol-defined range of 1.88 mmol/L to the upper limit of normal. Serum phosphorus was within the healthy range, and albumin-corrected serum calcium-phosphorus product was below the upper healthy limit throughout, while mean 24-h urine calcium excretion decreased from baseline to EOT. Mean supplemental doses of calcium and active vitamin D were reduced from baseline to EOT (2402–855 mg/d and 0.8–0.2 μg/d, respectively). Mean serum bone turnover markers, bone-specific alkaline phosphatase, osteocalcin, procollagen type I N-terminal propeptide, and type I collagen C-telopeptide increased 2–5 fold from baseline to EOT. The HCRU, disease-related symptoms and impact on HRQoL improved numerically between baseline and EOT. Nine patients (40.9%) experienced treatment-related adverse events; no deaths were reported. Treatment with rhPTH(1–84) once daily for 1 yr improved HRQoL, maintained eucalcemia in 95% of patients, normalized serum phosphorus, and decreased urine calcium excretion. The effects observed on urine calcium and the safety profile are consistent with previous findings.Clinical trial identifierNCT03364738.

2023-04-01·Endocrinology, Diabetes & Metabolism Case Reports

Use of rhPTH(1-84) for hypoparathyroidism during early pregnancy and lactation

Article

作者: Liao, E Pauline ; Cusano, Natalie E

SummaryWe present the first report of use of recombinant human parathyroid hormone (1-84) (rhPTH(1-84)) in a hypoparathyroid patient during early pregnancy and lactation. The patient developed postoperative hypoparathyroidism as a 28-year-old woman following total thyroidectomy for multinodular goiter. She was not well controlled with conventional therapy, and started rhPTH(1-84) in 2015 following its approval in the United States. She became pregnant in 2018 at age 40. She discontinued rhPTH(1-84) therapy at 5 weeks gestation but resumed in the postpartum period while breastfeeding. Her daughter’s serum calcium was borderline elevated at 8 days postpartum but within the normal range at 8 weeks postpartum. The patient stopped nursing at around 6 months postpartum. Her daughter is now at 4 years and 5 months of age and is healthy and meeting developmental milestones. She was again pregnant at 8 months postpartum from her first pregnancy, and she made an informed decision to continue parathyroid hormone. At 15 weeks gestation, rhPTH(1-84) was recalled in the United States due to issues with the delivery device, and she discontinued rhPTH(1-84) treatment and resumed calcium and calcitriol supplements. She gave birth to a baby boy at 39 weeks in January 2020. At 3 years and 2 months of age, he is overall healthy. Further data are needed regarding the safety of rhPTH(1-84) in pregnancy and lactation.Learning points

rhPTH(1-84) is approved for therapy of patients with hypoparathyroidism; however, there are no data regarding the safety of treatment during nursing and pregnancy.

There are multiple alterations in mineral metabolism during normal pregnancy and lactation.

100 项与重组人甲状旁腺素(1-84)(重庆科润生物医药研发有限公司) 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
绝经期后骨质疏松	临床2期	中国	重庆科润生物医药研发有限公司	2013-10-28
甲状旁腺功能减退症	临床1期	丹麦	Shire Plc	2017-04-03
甲状旁腺功能减退症	临床1期	匈牙利	Shire Plc	2017-04-03
甲状旁腺功能减退症	临床1期	加拿大	Shire Plc	2017-04-03
甲状旁腺功能减退症	临床1期	美国	Shire Plc	2017-04-03