Trial · Interventional
WithdrawnPhase 3Registry dataA Clinical Study of rhPTH(1-84) Treatment in Japanese Participants With Chronic Hypoparathyroidism
This trial was withdrawn before it enrolled anyone.
Reason given at the registry: Business decision
Overview
- Status
- Withdrawn
- Phase
- Phase 3
- Enrollment
- 0 participants (actual)
- Sponsor
- Shire · Industry
- Design
- Allocation not applicable · Open label (no masking)
- Countries
1 country
Japan
- Start
- 31 Aug 2022 (estimated)
- Primary completion
- 31 May 2023 (estimated)
- Completion
- 31 May 2023 (estimated)
- First posted
- 18 Mar 2019
- Last update posted
- 10 Oct 2022
- Conditions
- Chronic Hypoparathyroidism
Timeline
1 trial · 1 stopped early
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 3Withdrawn
A Clinical Study of rhPTH(1-84) Treatment in Japanese Participants With Chronic Hypoparathyroidism
NCT03878953est. 31 Aug 2022 to est. 31 May 2023
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
This clinical study aims to evaluate the safety and efficacy of repeated dosing of recombinant human parathyroid hormone (rhPTH\[1-84\]) in Japanese participants with chronic hypoparathyroidism for a 26-week period.
Interventions
- rhPTH(1-84)Drug
Arms1
Experimental
rhPTH(1-84)
Participants will receive a SC injection of initial dose of 50 mcg of rhPTH(1-84) once daily (QD) in the thigh (alternate thigh every day). If albumin-corrected serum calcium (ACSC; \[mg/dL\] = serum calcium \[mg/dL\] +0.8\*\[4-serum albumin (g/dL)\]) is \>2.25 mmol/L (\>9.0 mg/dL), a starting dose of 25 mcg will be considered. At 4 week intervals the rhPTH(1-84) dose may be increased in 25 mcg increments to a maximal dose of 100 mcg SC QD. At any time during the study as needed for safety reasons, rhPTH(1-84) doses may be decreased in 25 mcg decrements to a minimum of 25 mcg QD. If the ACSC is \>2.97 mmol/L (\>11.9 mg/dL), then the investigational product should be stopped until the calcium level is corrected.
Primary outcomes2
Outcomes the sponsor listed as primary.
Number of Responders at Week 26
Time frame · Week 26
Registry description
Number of participants who achieved an albumin-corrected total serum calcium concentration that is maintained or normalized compared to baseline and does not exceed the upper limit of the reference range for the laboratory, at least a 50% reduction from baseline amounts of active vitamin D therapy and at least a 50% reduction from the baseline oral calcium supplement dose (this criterion will be considered met if the participant's baseline calcium dose is \<1000 mg and it does not increase during the study will be reported.
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame · From start of study treatment up to 30 weeks
Registry description
An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this study treatment. A TEAE is defined as any event emerging or manifesting at or after the initiation of treatment with an investigational product or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the investigational product or medicinal product.
Secondary outcomes(2)
Change From Baseline in Serum Phosphate Level
Time frame · Baseline, Weeks 1, 2, 4, 6, 8, 10, 12, 14, 16, 20, 24, 26 and 30
Registry description
Change from baseline in serum phosphate level will be reported.
Change From Baseline in Urine Calcium Level
Time frame · Baseline, Week 26
Registry description
Change from baseline in urine calcium level will be reported.
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
No results are posted for this trial.
A trial that is still running, or that stopped early, may post results later.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 20 Years up to 85 Years
- Healthy volunteers
- Not accepted
Inclusion and exclusion criteria, as posted
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