Trial · NCT03364738
Safety and Efficacy Study of rhPTH(1-84) in Subjects With Hypoparathyroidism
NCT03364738, Phase 3, Terminated, Shire; results first posted 2021-06-16
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy Study of rhPTH(1-84) in Subjects With Hypoparathyroidism. Trials, record NCT03364738. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03364738
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy Study of rhPTH(1-84) in Subjects With Hypoparathyroidism
- NCT number
- NCT03364738
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 22 participants, actual
- Lead sponsor
- Shire
- Conditions
- Hypoparathyroidism
- Interventions
- rhPTH(1-84)
- First posted
- 2017-12-07
- Last updated
- 2022-10-07
- Other registries' IDs
- eudract:2017-003067-36
- Results first posted
- 2021-06-16
- Limitations and caveats
- The study was terminated due to Takeda commercial Natpara recall.
Source ClinicalTrials.gov
Registered outcomes21
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Achieved Total Albumin-corrected Serum Calcium (ACSC) Values Greater Than or Equal to (>=) to the Range of 7.5 mg/dL (1.875 mmol/L) and Less Than or Equal to (<=) Upper Limit of Normal (ULN) at Week 24 | At Week 24 | Percentage of participants who achieved ACSC values \>= to range of 1.875 mmol/L and \<= ULN at Week 24 was reported. |
| Primary | Percentage of Participants With Total ACSC Values >= to the Range of 7.5 mg/dL (1.875 mmol/L) and <=ULN at Week 52 (End-of-treatment [EOT]) | At Week 52 (EOT) | Percentage of participants who achieved ACSC values \>= to range of 1.875 mmol/L and \<= ULN at Week 52 (EOT) was reported. |
| Primary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs | From start of study drug administration to end of study (Week 56) | An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. A Serious Adverse Event (SAE) was any untoward medical occurrence (whether considered to be related to investigational product or not) that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital abnormality/birth defect, and is an important medical event. TEAEs were defined as AEs with a start date on or after the first dose of investigational product or a start date before the date of the first dose of investigational product that increased in severity or after the date of the first dose. |
| Primary | Number of Participants With Clinically Significant Change in Clinical Laboratory Values | From start of study drug administration to end of study (Week 56) | Clinical laboratory assessment included hematology, serum chemistry, urine chemistry and urinalysis. Clinical significance was judged by the investigator based upon the out of range values of standard range set for each parameter. Any changes in clinical laboratory results which were deemed clinically significant by the investigator was reported. |
| Primary | Number of Participants With Clinically Significant Change in Vital Sign | From start of study drug administration to end of study (Week 56) | Vital sign parameters included: temperature, pulse rate, respiration rate, systolic and diastolic blood pressure. Clinical significance was judged by the investigator based upon the out of range values of standard range set for each parameter. Any changes in vital signs which were deemed clinically significant by the investigator was reported. |
| Primary | Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Parameters | From start of study drug administration to end of study (Week 56) | Twelve-lead ECGs was performed in triplicate with a minimum 2-minute gap between traces. The participant rested in the supine position for at least 5 minutes before collecting the ECG. Assessment of ECG parameters included: heart rate, RR interval, PR interval, QRS interval, QT interval, and QTc interval. Clinical significance was judged by the investigator based upon the out of range values of standard range set for each parameter. Any change in ECG assessments which were deemed clinically significant by the investigator was reported. |
| Primary | Number of Participants With Clinically Significant Change in Estimated Glomerular Filtration Rate (eGFR) Values | From start of study drug administration to end of study (Week 56) | eGFR was calculated using the chronic kidney disease epidemiology (CDK-epi) formula. Clinical significance was judged by the investigator based upon the out of range values of standard range set for parameter. Any change in eGFR assessments which were deemed clinically significant by the investigator was reported. |
| Primary | Number of Participants With Clinically Significant Change in Serum Creatinine Value | From start of study drug administration to end of study (Week 56) | eGFR was assessed by measuring serum creatinine. Serum creatinine level was obtained directly from laboratory results. Clinical significance was judged by the investigator based upon the out of range values of standard range set for parameter. Any change in serum creatinine assessments which were deemed clinically significant by the investigator was reported. |
| Primary | Number of Participants With Positive Anti-Parathyroid Hormone Antibodies at Week 24 | Week 24 | Number of participants with positive anti-parathyroid hormone antibodies at Week 24 was reported. |
| Primary | Number of Participants With Positive Anti-Parathyroid Hormone Antibodies at Week 52 (EOT) | Week 52 (EOT) | Number of participants with positive anti-parathyroid hormone antibodies at Week 52 (EOT) was reported. |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 registered outcomesOutcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Who Achieved Total Albumin-corrected Serum Calcium (ACSC) Values Greater Than or Equal to (>=) to the Range of 7.5 mg/dL (1.875 mmol/L) and Less Than or Equal to (<=) Upper Limit of Normal (ULN) at Week 24 | At Week 24 | Safety analysis population consisted of all participants who had received at least 1 dose of rhPTH(1-84). Here overall number of participants analyzed were participants who were evaluable for this outcome measure. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants With Total ACSC Values >= to the Range of 7.5 mg/dL (1.875 mmol/L) and <=ULN at Week 52 (End-of-treatment [EOT]) | At Week 52 (EOT) | Safety analysis population consisted of all participants who had received at least 1 dose of rhPTH(1-84). | percentage of participants | NUMBER |
| PRIMARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs | From start of study drug administration to end of study (Week 56) | Safety analysis population consisted of all participants who had received at least 1 dose of rhPTH(1-84). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Change in Clinical Laboratory Values | From start of study drug administration to end of study (Week 56) | Safety analysis population consisted of all participants who had received at least 1 dose of rhPTH(1-84). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Change in Vital Sign | From start of study drug administration to end of study (Week 56) | Safety analysis population consisted of all participants who had received at least 1 dose of rhPTH(1-84). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Parameters | From start of study drug administration to end of study (Week 56) | Safety analysis population consisted of all participants who had received at least 1 dose of rhPTH(1-84). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Change in Estimated Glomerular Filtration Rate (eGFR) Values | From start of study drug administration to end of study (Week 56) | Safety analysis population consisted of all participants who had received at least 1 dose of rhPTH(1-84). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Change in Serum Creatinine Value | From start of study drug administration to end of study (Week 56) | Safety analysis population consisted of all participants who had received at least 1 dose of rhPTH(1-84). | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Positive Anti-Parathyroid Hormone Antibodies at Week 24 | Week 24 | Safety analysis population consisted of all participants who had received at least 1 dose of rhPTH(1-84). Here overall number of participants analyzed were participants who were evaluable for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline in Albumin Corrected Serum Calcium (ACSC) Concentration at Weeks 24 and 52 (EOT) | Baseline, Weeks 24 and 52 (EOT) | Safety analysis population consisted of all participants who had received at least 1 dose of rhPTH(1-84). Here number analyzed were participants who were evaluable for the outcome measure at given time points. | mmol/L | MEAN |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 outcomesResults by group59
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Percentage of Participants Who Achieved Total Albumin-corrected Serum Calcium (ACSC) Values Greater Than or Equal to (>=) to the Range of 7.5 mg/dL (1.875 mmol/L) and Less Than or Equal to (<=) Upper Limit of Normal (ULN) at Week 24 | rhPTH(1-84) | 100 | percentage of participants | ||
| Percentage of Participants With Total ACSC Values >= to the Range of 7.5 mg/dL (1.875 mmol/L) and <=ULN at Week 52 (End-of-treatment [EOT]) | rhPTH(1-84) | 95.5 | 0.772 to 0.999 | percentage of participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs | rhPTH(1-84) | Participants with TEAEs | 17 | Participants | |
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs | rhPTH(1-84) | Participants with serious TEAEs | 4 | Participants | |
| Number of Participants With Clinically Significant Change in Clinical Laboratory Values | rhPTH(1-84) | 0 | Participants | ||
| Number of Participants With Clinically Significant Change in Vital Sign | rhPTH(1-84) | 0 | Participants | ||
| Number of Participants With Clinically Significant Change in Electrocardiogram (ECG) Parameters | rhPTH(1-84) | 0 | Participants | ||
| Number of Participants With Clinically Significant Change in Estimated Glomerular Filtration Rate (eGFR) Values | rhPTH(1-84) | 0 | Participants | ||
| Number of Participants With Clinically Significant Change in Serum Creatinine Value | rhPTH(1-84) | 0 | Participants | ||
| Number of Participants With Positive Anti-Parathyroid Hormone Antibodies at Week 24 | rhPTH(1-84) | 0 | Participants |
1 to 10 of 59Source ClinicalTrials.gov
See all 59 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | rhPTH(1-84) | 22 | |
| Overall Study | COMPLETED | rhPTH(1-84) | 14 | |
| Overall Study | NOT COMPLETED | rhPTH(1-84) | 8 |
Source ClinicalTrials.gov
Adverse events18
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | rhPTH(1-84) | 6 | 22 | 7 |
| other | Vomiting | Gastrointestinal disorders | rhPTH(1-84) | 2 | 22 | 4 |
| other | Fatigue | General disorders | rhPTH(1-84) | 4 | 22 | 5 |
| other | Nasopharyngitis | Infections and infestations | rhPTH(1-84) | 3 | 22 | 3 |
| other | Hypercalcaemia | Metabolism and nutrition disorders | rhPTH(1-84) | 4 | 22 | 5 |
| other | Hypocalcaemia | Metabolism and nutrition disorders | rhPTH(1-84) | 2 | 22 | 4 |
| other | Muscle spasms | Musculoskeletal and connective tissue disorders | rhPTH(1-84) | 3 | 22 | 6 |
| other | Myalgia | Musculoskeletal and connective tissue disorders | rhPTH(1-84) | 2 | 22 | 2 |
| other | Osteoarthritis | Musculoskeletal and connective tissue disorders | rhPTH(1-84) | 2 | 22 | 2 |
| other | Tendonitis | Musculoskeletal and connective tissue disorders | rhPTH(1-84) | 2 | 22 | 2 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | rhPTH(1-84) | 0 | 22 |
| Total, other adverse events | rhPTH(1-84) | 10 | 22 |
| Total, serious adverse events | rhPTH(1-84) | 4 | 22 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 38741607 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03364738
GET https://conductscience.org/api/trials/v1/NCT03364738/registered?page=2