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Study to Assess the Blood Concentrations and Actions of Recombinant Human Parathyroid Hormone (rhPTH [1-84]) When Given Once and Twice Daily to Subjects With Hypoparathyroidism (PARALLAX)

This study is currently recruiting participants.
Verified December 2017 by Shire
Sponsor:
ClinicalTrials.gov Identifier:
NCT02781844
First Posted: May 25, 2016
Last Update Posted: December 15, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Shire
  Purpose
This study is being conducted to characterize the effects of twice daily administration of rhPTH(1-84) on the way the body handles rhPTH(1-84) as well as its actions and safety and tolerability over the course of 24 hours as compared with the current once daily dosing regimen of marketed rhPTH(1-84) (marketed in the United States as Natpara®).

Condition Intervention Phase
Hypoparathyroidism Drug: 25mcg rhPTH(1-84) Drug: 50mcg rhPTH(1-84) Drug: 100mcg rhPTH(1-84) Drug: rhpth(1-84) Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Randomized, Crossover Study to Assess the Pharmacokinetic and Pharmacodynamic Profiles of Once Daily and Twice Daily Dose Regimens of Recombinant Human Parathyroid Hormone (rhPTH[1-84]) Administered Subcutaneously to Subjects With Hypoparathyroidism

Resource links provided by NLM:


Further study details as provided by Shire:

Primary Outcome Measures:
  • The pharmacokinetic profile of rhPTH(1-84) as measured by plasma PTH concentrations [ Time Frame: Baseline up to a maximum of 65 days ]
    Assessment will be based on the effects of the subcutaneous doses of 25μg administered twice-daily, 50μg administered twice-daily, and 100μg administered once-daily, as well as the effect of supplemental oral calcium intake, in subjects with hypoparathyroidism

  • The pharmacodynamic effects of rhPTH(1-84) ± supplemental calcium as measured by control of serum calcium [ Time Frame: Baseline up to a maximum of 65 days ]
    Assessment will be based on the effects of the subcutaneous doses of 25μg administered twice-daily, 50μg administered twice-daily, and 100μg administered once-daily, as well as the effect of supplemental oral calcium intake, in subjects with hypoparathyroidism

  • The pharmacodynamic effects of rhPTH(1-84) ± supplemental calcium as measured by urinary calcium excretion [ Time Frame: Baseline up to a maximum of 65 days ]
    Assessment will be based on the effects of the subcutaneous doses of 25μg administered twice-daily, 50μg administered twice-daily, and 100μg administered once-daily, as well as the effect of supplemental oral calcium intake, in subjects with hypoparathyroidism


Secondary Outcome Measures:
  • The safety and tolerability of rhPTH(1-84) as measured by AEs and SAEs [ Time Frame: Baseline to Follow-up (approx. 2 months) ]
    AEs and SAEs will be measured by any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal (investigational) product


Estimated Enrollment: 32
Actual Study Start Date: March 11, 2017
Estimated Study Completion Date: May 31, 2019
Estimated Primary Completion Date: May 31, 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A/B or B/A
Participants will be randomized to either receive 25 microgram (mcg) rhPTH(1-84) twice daily with no calcium for treatment period 1 and 100mcg rhPTH(1-84) once daily with no calcium for treatment period 2; or 100mcg rhPTH(1-84) once daily with no calcium for treatment period 1 and 25mcg rhPTH(1-84) BID with no calcium for treatment period 2
Drug: 25mcg rhPTH(1-84)
25mcg
Other Name: PTH
Drug: 100mcg rhPTH(1-84)
100mcg
Other Name: PTH
Drug: rhpth(1-84)
rhpth(1-84)
Experimental: C/B or B/C
Participants will be randomized to either receive 50mcg rhPTH(1-84) twice daily with no calcium for treatment period 1 and 100mcg rhPTH(1-84) once daily with no calcium for treatment period 2; or 100mcg rhPTH(1-84) once daily with no calcium for treatment period 1 and 50mcg rhPTH(1-84) twice daily with no calcium for treatment period 2
Drug: 50mcg rhPTH(1-84)
50mcg
Other Name: PTH
Drug: 100mcg rhPTH(1-84)
100mcg
Other Name: PTH
Drug: rhpth(1-84)
rhpth(1-84)
Experimental: D/E or E/D
Participants will be randomized to either receive 25mcg rhPTH(1-84) twice daily with calcium for treatment period 1 and 100mcg rhPTH(1-84) once daily with calcium for treatment period 2; or 100mcg rhPTH(1-84) once daily with calcium for treatment period 1 and 25mcg rhPTH(1-84) twice daily with calcium for treatment period 2
Drug: 25mcg rhPTH(1-84)
25mcg
Other Name: PTH
Drug: 100mcg rhPTH(1-84)
100mcg
Other Name: PTH
Drug: rhpth(1-84)
rhpth(1-84)
Experimental: F/E or E/F
Participants will be randomized to either receive 50mcg rhPTH(1-84) twice daily with calcium for treatment period 1 and 100mcg rhPTH(1-84) once daily with calcium for treatment period 2; or 100mcg rhPTH(1-84) once daily with calcium for treatment period 1 and 50mcg rhPTH(1-84) twice daily with calcium for treatment period 2
Drug: 50mcg rhPTH(1-84)
50mcg
Other Name: PTH
Drug: 100mcg rhPTH(1-84)
100mcg
Other Name: PTH
Drug: rhpth(1-84)
rhpth(1-84)

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. History of hypoparathyroidism
  2. Requirement for supplemental oral calcium treatment ≥ 1000 mg per day.
  3. Requirement for active vitamin D therapy at a dose of ≥ 0.25 mcg per day . (i.e., ≥ 0.25 mcg calcitriol or equivalent per day).
  4. Serum calcium levels within the laboratory normal range based on clinical chemistry lab results at Screening (central and/or local lab) and Treatment Period 1, Day -2 (central and/or local lab) or, if outside the normal range, considered as not significant by the Investigator.
  5. Urinary calcium excretion ≥200 mg (5mmol)/24h, based on a 24-hour collection prior to check-in to the CRC at Treatment Period 1, Day -2 (central and/or local lab).
  6. Serum magnesium level within the laboratory normal range at the screening examination or, if outside the normal range, considered as not significant by the Investigator.
  7. Serum thyroid function tests within normal laboratory limits at screening, or if outside of the normal range, considered as not clinically significant by the Investigator.
  8. Serum 25(OH) D level between the lower limit of normal and 1.5 fold the laboratory upper limit of normal at the first screening visit or, if outside the normal range, considered as not significant by the Investigator.
  9. Serum creatinine < 1.5 mg/dL (<133 micromol/L) AND creatinine clearance > 60 mL/ minute(>1.002mL/s).

Key Exclusion Criteria:

  1. Participation in any other investigational drug study within the last 3 months
  2. Use of any of the following prior to study drug administration:

(1) 14 days: thiazide diuretics (2) 30 days: loop diuretics, lithium, , systemic corticosteroid (3) 3 months: calcitonin, cinacalcet hydrochloride, rhPTH(1-84) or N-terminal PTH or PTH-related peptide fragments or analogs (4) females only; changes in hormone replacement therapy within 3 months (5) 6 months: fluoride tablets, oral bisphosphonates, methotrexate growth hormone, digoxin; raloxifene or similar selective estrogen receptor modulators (6) 12 months: intravenous bisphosphonates, drug or alcohol abuse 3. 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 as determined by the Investigator.

4. Known history of hypoparathyroidism resulting from an activating mutation in the calcium sensing receptor (CaSR) gene or impaired responsiveness to PTH (pseudohypoparathyroidism).

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02781844


Contacts
Contact: Shire Contact 1 866-842-5335 clinicaltransparency@shire.com

Locations
United States, California
Providence Clinical Research Recruiting
North Hollywood, California, United States, 91606
Contact: Dalia Kuko, MD       dkuko@providenceclinical.com   
Principal Investigator: Teresa Sligh, MD         
United States, Indiana
Indiana University Recruiting
Bloomington, Indiana, United States, 46202
Contact: Munro Peacock    317-274-4356    MPEACOCK@IU.EDU   
Principal Investigator: Munro Peacock         
United States, Louisiana
Crescent City Clinical Research Center Recruiting
Metairie, Louisiana, United States, 70006
Contact: Jonathon Wise, MD       jwisemd@gmail.com   
Principal Investigator: Jonathon Wise, MD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Bart Clarke, MD       roberson.tamera@mayo.edu   
Principal Investigator: Bart Clarke, MD         
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Mishaela Rubin, MD       mrr6@cumc.columbia.edu   
Principal Investigator: Mishaela Rubin, MD         
United States, Ohio
Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Amber Anaya    614-688-6257    amber.anaya@osumc.edu   
Principal Investigator: Steven Ing, MD         
United States, Pennsylvania
Thomas Jefferson University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Intekhab Ahmed, MD    215-955-8405    marsha.simmons@jefferson.edu   
Principal Investigator: Intekhab Ahmed, MD         
United States, Tennessee
NOCCR Recruiting
Knoxville, Tennessee, United States, 37920
Contact: Sandra Gibson    865-305-9100    sigibson@noccr.com   
Principal Investigator: William Smith, MD         
Sponsors and Collaborators
Shire
Investigators
Study Director: Shire Physician Shire
  More Information

Additional Information:
Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT02781844     History of Changes
Other Study ID Numbers: SHP634-101
2015-004757-40 ( EudraCT Number )
First Submitted: April 19, 2016
First Posted: May 25, 2016
Last Update Posted: December 15, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hypoparathyroidism
Parathyroid Diseases
Endocrine System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs