A Open-label Study Investigating the Safety and Tolerability of NPSP558, a Recombinant Human Parathyroid Hormone (rhPTH [1-84]), for the Treatment of Adults With Hypoparathyroidism - A Clinical Extension Study (RACE)

• Register: ClinicalTrials.gov
• Last refreshed on: 7 June 2021
• Main ID: NCT01297309
• Date of registration: 11/02/2011
• Prospective Registration: Yes
• Primary sponsor: Shire
• Public title: A Open-label Study Investigating the Safety and Tolerability of NPSP558, a Recombinant Human Parathyroid Hormone (rhPTH [1-84]), for the Treatment of Adults With Hypoparathyroidism - A Clinical Extension Study (RACE)
• Scientific title: A Long-term Open-label Study Investigating the Safety and Tolerability of NPSP558, a Recombinant Human Parathyroid Hormone (rhPTH[1-84]), for the Treatment of Adults With Hypoparathyroidism - A Clinical Extension Study (RACE)
• Date of first enrolment: April 6, 2011
• Target sample size: 51
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01297309
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

United States

Contacts

• Name: Study Director
• Affiliation: Takeda

Key inclusion & exclusion criteria

Inclusion Criteria:

- Previously completed the rhPTH[1-84] RELAY study (8 weeks of active therapy) and/or
previously completed the rhPTH[1-84] REPLACE study (Visit 18).

- Able to perform daily SC self-injections of study medication (or have a designee
perform injection).

- Women who are (1) postmenopausal; (2) surgically sterilized; or, (3) of childbearing
potential with a negative pregnancy test and who consent to use two acceptable methods
of contraception for the duration of the study.

- Males who have female partners of childbearing potential must use two acceptable forms
of contraception for the duration of the study.

- Serum creatinine <1.5 mg/dL at enrollment.

- Total serum calcium less than or equal to upper limit of normal (ULN) based on local
laboratory result prior to enrollment.

- Serum 25 hydroxy (OH) vitamin D less than or equal to 1.5 times the ULN within
approximately 16 weeks prior to enrollment.

Exclusion Criteria:

- Any condition that, in the investigator's opinion after consultation with the sponsor,
would preclude the safe use of parathyroid hormone (PTH).

- Pregnant or lactating women.

- Any disease or condition which has a high probability of precluding the subject from
completing the study or where the subject cannot or will not appropriately comply with
study requirements.



Age minimum: 18 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

Hypoparathyroidism

Intervention(s)

Drug: NPSP558

Primary Outcome(s)

Number of Responders With Calcium Source at End Of Treatment (EOT) (Up to 82 Months) [Time Frame: EOT (up to 82 months)]

Number of Participants With Treatment Emergent Adverse Event (TEAE) and Treatment Emergent Serious Adverse Event (TESAE) [Time Frame: From start of study drug administration up to follow-up (82 months)]

Number of Responders With Calcium Source at Week 52 [Time Frame: Week 52]

Secondary Outcome(s)

Percent Change From Baseline in Oral Calcitriol Supplementation at Week 52 and EOT (Up to 82 Months) [Time Frame: Baseline, Week 52 and EOT (up to 82 months)]

Change From Baseline in 24-hour Urine Calcium Excretion in Participants Who Used Calcium-Sparing Diuretics Through EOT (Up to 82 Months) [Time Frame: Baseline, EOT (up to 82 months)]

Change From Baseline in Serum Phosphate at Month 72 and EOT (Upto 82 Months) [Time Frame: Baseline, Month 72, EOT (upto 82 months)]

Percent Change From Baseline in Oral Calcium Supplementation at Week 52 and EOT (Up to 82 Months) [Time Frame: Baseline, Week 52 and EOT (up to 82 months)]

Change From Baseline in Bone Turnover Markers at EOT (Up to 82 Months) [Time Frame: Baseline, EOT (up to 82 months)]

Change From Baseline in Serum Calcium Concentration in Participants Who Used and Calcium Sparing Diuretics at EOT (Upto 82 Months) [Time Frame: Baseline, EOT (upto 82 months)]

Percent Change From Baseline in Albumin Corrected Total Serum Calcium (ACSC) at EOT (Up to 82 Months) [Time Frame: Baseline, EOT (up to 82 months)]

Change From Baseline in 24-Hour Urine Calcium Excretion Through EOT (Up to 82 Months) [Time Frame: Baseline, EOT (up to 82 months)]

Change From Baseline in Bone Mineral Density (BMD) at Week 52 and EOT (Up to 82 Months) [Time Frame: Baseline, Week 52 and EOT (up to 82 months)]

Change From Baseline in Serum Carboxy Terminal Telopeptide of Type I Collagen (s-CTx) Bone Turnover Marker at EOT (Up to 82 Months) [Time Frame: Baseline, EOT (up to 82 months)]

Number of Participants Who Maintained a Calcium Phosphate Product in A Normal Range at EOT (Up to 82 Months) [Time Frame: EOT (up to 82 months)]

Secondary ID(s)

PAR-C10-008

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 06/08/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01297309