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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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14 June 2021 |
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Main ID: |
NCT01268098 |
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Date of registration:
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28/12/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Study of Safety and Efficacy of a rhPTH[1-84] of Fixed Doses of 25 and 50 mcg in Adults With Hypoparathyroidism (RELAY)
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Scientific title:
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A Randomized, Dose-blinded Study to Investigate the Safety and Efficacy of NPSP558, a Recombinant Human Parathyroid Hormone [rhPTH(1-84)], at Fixed Doses of 25 µg and 50 µg for the Treatment of Adults With Hypoparathyroidism |
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Date of first enrolment:
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February 9, 2011 |
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Target sample size:
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42 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01268098 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 3
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Countries of recruitment
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United States
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Contacts
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Name:
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Study Director |
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Address:
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Telephone:
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Email:
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Affiliation:
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Takeda |
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Key inclusion & exclusion criteria
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Main Inclusion Criteria:
1. Previously completed 24 weeks of therapy and 4 weeks of follow-up in the REPLACE study
2. With regard to female patients: women who are postmenopausal or willing to use two
medically acceptable methods of contraception for the duration of the study with
pregnancy testing conducted at every scheduled office visit
3. Total serum calcium = ULN based on local laboratory results prior to randomization
4. Serum 25(OH) vitamin D = 1.5 times the ULN within approximately 8 weeks prior to
randomization
Main Exclusion Criteria:
1. Any disease or condition that, in the opinion of the investigator, has a high
probability of precluding the patient from completing the study or being able to
appropriately comply with study requirements
2. Use of raloxifene hydrochloride or intravenous (IV) bisphosphonates since the end of
participation in the REPLACE trial
3. Chronic (ie, = 1 month exposure) use of systemic corticosteroids, oral
bisphosphonates, calcitonin, fluoride tablets, or cinacalcet hydrochloride
4. Pregnant or lactating women
5. Any condition that would, in the investigator's opinion in consultation with the
sponsor, preclude the safe use of PTH
6. Use of any experimental drug other than NPSP558 within 3 months of baseline.
Age minimum:
18 Years
Age maximum:
85 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Hypoparathyroidism
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Intervention(s)
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Drug: NPSP558
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Primary Outcome(s)
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Percentage of Subjects Who Achieved the Primary Triple Endpoint at Week 8, Based on Investigator Prescribed Data.
[Time Frame: 8 Weeks]
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Secondary Outcome(s)
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The Percentage of Subjects Who Met the Triple Efficacy Endpoint Criteria at Week 8.
[Time Frame: 8 Weeks]
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Secondary ID(s)
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PAR-C10-007
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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