Safety and Efficacy Study of rhPTH(1-84) in Subjects With Hypoparathyroidism

NCT ID: NCT03364738

Last Updated: 2022-10-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-26
• Study Completion Date: 2020-04-14

Brief Summary

This study is open to adults with hypoparathyroidism who complete the SHP634-101 study (PARALLAX Study). The purpose of this study is to see if rhPTH(1-84) is safe and effective in adults with hypoparathyroidism who previously participated in the SHP634-101 study. All participants enrolled in this study will receive rhPTH(1-84) once-daily for 52 weeks via an injection.

Patients who complete the SHP634-101 study will have the option to screen for this extension study.

Conditions

Hypoparathyroidism

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

rhPTH(1-84)

Participants will receive rhPTH(1-84) subcutaneous (SC) injection in the thigh (alternate thigh every day) once daily (QD) of an escalating dose from 50 microgram (mcg) to a maximum of 100 mcg increased in increments of 25 mcg no more frequently than every 2 to 4 weeks, with the goal of achieving or maintaining albumin-corrected serum calcium (ACSC) levels in the range of 2-2.25 millimoles per liter (mmol/L) (8.0-9.0 milligrams per deciliter \[mg/dL\]). Once a participant achieves a stable ACSC (2-2.25 mmol/L \[8.0-9.0mg/dL\]) and has minimized supplement doses, they will be maintained at that dose of rhPTH(1-84). If ACSC is greater than (\>) 2.25 mmol/L (\>9.0 mg/dL), a starting dose of 25 mcg will be administered.

Group Type: EXPERIMENTAL

rhPTH(1-84)

Intervention Type: BIOLOGICAL

Participants will receive rhPTH(1-84) SC injection in the thigh (alternate thigh every day) QD.

Interventions

rhPTH(1-84)

Participants will receive rhPTH(1-84) SC injection in the thigh (alternate thigh every day) QD.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• An understanding, ability, and willingness to fully comply with study procedures and restrictions
• Ability to voluntarily provide written, signed, and dated informed consent to participate in the study.
• Previously completed the SHP634-101 (NCT02781844) study, including the 30-day follow-up.
• Male or non-pregnant, non-lactating female subjects who agree to comply with applicable contraceptive requirements of the protocol or females of non-childbearing potential.

Exclusion Criteria

• Received investigational study drug, aside from that received in study SHP634-101 (NCT02781844), within 3 months prior to the screening visit.
• Presence or history of a clinically significant disorder involving the cardiovascular, respiratory, renal, gastrointestinal, immunologic, hematologic, endocrine (with exception of the condition under study), or neurologic system(s) or psychiatric disease, that in the opinion of the investigator, would make the subject unsuitable for this study.
• Received parathyroid hormone (PTH), PTH analog, or parathyroid hormone fragment 1-34 [PTH(1-34)] treatment within the last 30 days from the screening visit.
• Subjects with a history of parathyroid hormone intolerance, based on investigator determination.
• Any disease that might affect calcium metabolism or calcium-phosphate homeostasis as determined by the investigator other than hypoparathyroidism, including but not limited to, active hyperthyroidism; poorly controlled insulin-dependent diabetes mellitus or type 2 diabetes mellitus; severe and chronic cardiac, liver or renal disease; Cushing's syndrome; neuromuscular disease such as rheumatoid arthritis; myeloma; pancreatitis; malnutrition; rickets; recent prolonged immobility; active malignancy, bone metastases or a history of skeletal malignancies; primary or secondary hyperparathyroidism; a history of parathyroid carcinoma; hypopituitarism, acromegaly; or multiple endocrine neoplasia types 1 and 2 .
• Subjects who are at increased baseline risk for osteosarcoma such as subjects with Paget's disease of bone or unexplained elevations of alkaline phosphatase, young adult subjects with open epiphyses, subjects with hereditary disorders predisposing to osteosarcoma or subjects with a prior history of external beam or implant radiation therapy involving the skeleton.
• Use of the following medications prior to administration of investigational product within:

1. 30 days-loop diuretics, lithium, systemic corticosteroids (medical judgment is required by the investigator. Primarily high doses of systemic corticosteroids [example (eg), prednisone] should be excluded. Stable doses of hydrocortisone [eg, as treatment for Addison's disease] may be acceptable).

2. 3 months-cinacalcet hydrochloride

3. 6 months-fluoride tablets, oral bisphosphonates, methotrexate, growth hormone, digoxin

4. 12 months-intravenous bisphosphonates, drug or alcohol abuse, as determined by the investigator

• Presence of any clinically significant results from laboratory tests, vital signs assessments, or electrocardiograms (ECG), that in the opinion of the investigator, would make the subject unsuitable for this study.
• Any medical condition or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for this study.
• History of a clinically significant illness during the 4 weeks prior to dosing, that in the opinion of the investigator, would make the subject unsuitable for this study.
• History of any clinically significant surgery or procedure within 8 weeks of first dose, as determined by the investigator or expected to undergo a major surgical procedure during the trial.
• History of an allergic response(s) to PTH, PTH analogs, or PTH(1-34), or other clinically significant allergies, that in the opinion of the investigator, would make the subject unsuitable for this study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shire

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Shire

Locations

University of Kentucky Medical Center

Lexington, Kentucky, United States

Crescent City Clinical Research Center, LLC

Metairie, Louisiana, United States

Northern Nevada Endocrinology - Lisa Abbott MD

Reno, Nevada, United States

Ohio State University

Columbus, Ohio, United States

Thomas Jefferson University, Jefferson Rheumatology Associates

Philadelphia, Pennsylvania, United States

Bone Research and Education Centre

Oakville, Ontario, Canada

CHU de Quebec-Universite Laval

Québec, , Canada

Aarhus Universitetshospital

Aarhus N, , Denmark

Semmelweis Egyetem

Budapest, , Hungary

Pecsi Tudomanyegyetem, I. sz. Belgyogyaszati Klinika

Pécs, , Hungary

Countries

United States; Canada; Denmark; Hungary

References

Khan AA, Abbott LG, Ahmed I, Ayodele O, Gagnon C, Finkelman RD, Mezosi E, Rejnmark L, Takacs I, Yin S, Ing SW. Open-label extension of a randomized trial investigating safety and efficacy of rhPTH(1-84) in hypoparathyroidism. JBMR Plus. 2024 Jan 5;8(3):ziad010. doi: 10.1093/jbmrpl/ziad010. eCollection 2024 Mar.

Reference Type: DERIVED

PMID: 38741607 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2017-003067-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

SHP634-404

Identifier Type: -

Identifier Source: org_study_id