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NCT05778071 · ClinicalTrials.gov registry record · Phase 3
Evaluation of the Safety and Efficacy of Eneboparatide (AZP-3601) in Patients With Chronic Hypoparathyroidism
A Phase 3 study of Endocrine System Diseases and Chronic Hypoparathyroidism, sponsored by Alexion Pharmaceuticals.
- Active
- Registry status
- Phase 3
- Development phase
- 165
- Enrollment target
- 20
- Study locations
NCT05778071: Active Phase 3 study of Endocrine System Diseases and Chronic Hypoparathyroidism, sponsored by Alexion Pharmaceuticals.
NCT05778071 is a Phase 3 study of Endocrine System Diseases and Chronic Hypoparathyroidism that is active but no longer recruiting, run by Alexion Pharmaceuticals. The registered enrollment target is 165 participants, below the 334-participant average among 11 other Endocrine System Diseases trials with a reported enrollment target (51% lower). The trial reports 20 study locations across 16 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05778071, a Phase 3 study of Endocrine System Diseases and Chronic Hypoparathyroidism, is active but no longer recruiting, sponsored by Alexion Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 165 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is investigating the safety and efficacy of eneboparatide (AZP-3601) in patients with chronic hypoparathyroidism (cHP). During the first 24 weeks of the trial, participants will be randomized to receive eneboparatide or placebo. Study treatment is blinded: patients and doctors will not know which group each patient has been randomized to. All patients will start with a fixed dose of study treatment (eneboparatide or placebo), administered subcutaneously with a pre-filled pen. Study treatment will be individually titrated. After completion of the first 24 weeks, patients will be treated in the open label extension part of the study for 132 weeks. During this phase, all patients (including patients that were in the placebo group) will receive eneboparatide.
Primary Outcome
After 24 weeks of treatment, the proportion of patients in the eneboparatide treatment group vs. placebo: * Achieving complete independence from active vitamin D; * Achieving independence from therapeutic doses of oral calcium (i.e. taking oral elemental calcium supplements ≤600 mg/day); and * With albumin-adjusted serum calcium within the normal range (8.3 to 10.6 mg/dL).
Conditions Studied
Interventions
- COMBINATION_PRODUCT Placebo
- COMBINATION_PRODUCT eneboparatide
Study Locations (20)
Pennsylvania
- The Children's Hospital of Philadelphia (CHOP) - Philadelphia
- The Children's Hospital of Philadephia - Philadelphia
- Thomas Jefferson University - Philadelphia
Illinois
- University of Chicago - Medical Center - Chicago
- North Shore University Health System - Evanston
Other
- CHU de Quebec Research Centre - Québec
- Aarhaus University Hospital - Aarhus
California
- Harbor UCLA Medical Center Endocrinology - Torrance
Colorado
- Denver Endocrinology Diabetes and Thyroid Center - Denver
Indiana
- Indiana University (IU) Health University Hospital - Indianapolis
Massachusetts
- Massachusetts General Hospital - Boston
Minnesota
- Mayo Clinic - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 165 participants |
| Start Date | 2023-06-07 |
| Est. Completion | 2027-06-16 |
| Phase | Phase 3 |
What the registry record for NCT05778071 still lists
NCT05778071 is an interventional study that assigns participants to a tested intervention. The registered 165 participants enrollment target is mid-sized for trials with a published cap, below the 334-participant average among 11 other Endocrine System Diseases trials with a reported enrollment target (51% lower).
The record links to 3 conditions, with Endocrine System Diseases appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05778071 names 20 study sites across 16 states, led by Pennsylvania, Illinois, Other.
Frequently Asked Questions
What is clinical trial NCT05778071 about?
NCT05778071 is a clinical study titled "Evaluation of the Safety and Efficacy of Eneboparatide (AZP-3601) in Patients With Chronic Hypoparathyroidism". This study is investigating the safety and efficacy of eneboparatide (AZP-3601) in patients with chronic hypoparathyroidism (cHP). During the first 24 weeks of the trial, participants will be randomized to receive eneboparatide or placebo. Study treatment is blinded: patients and doctors will not k...
What is the current status of trial NCT05778071?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 165 participants. The study started on 2023-06-07. Estimated completion is 2027-06-16.
What conditions does trial NCT05778071 study?
This clinical trial studies the following conditions: Endocrine System Diseases, Chronic Hypoparathyroidism, Parathyroid Diseases.
What interventions are being tested in trial NCT05778071?
The interventions under investigation include: Placebo (COMBINATION_PRODUCT), eneboparatide (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT05778071?
This trial is sponsored by Alexion Pharmaceuticals, which has 162 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05778071 being conducted?
This trial has 20 study locations across California, Colorado, Illinois, Indiana, Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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