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NCT03602261 · ClinicalTrials.gov registry record · Phase 2
Safety, Efficacy, PK and PD of CTAP101 (Calcifediol) ER Capsules for SHPT in HD Patients VDI
A Phase 2 study, sponsored by OPKO Health.
- Terminated
- Registry status
- Phase 2
- Development phase
- 44
- Enrollment target
NCT03602261: Clinical Trial Phase 2 study, sponsored by OPKO Health.
NCT03602261 is a Phase 2 study that was terminated before completion, run by OPKO Health. The registered enrollment target is 44 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03602261, a Phase 2 study, was terminated before completion, sponsored by OPKO Health.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 44 participants
- Enrollment target
Study Summary
Safety, Efficacy, PK and PD of CTAP101 (calcifediol) ER Capsules for SHPT in HD Patients VDI
Primary Outcome
To evaluate the efficacy of repeated dosing with 900 mcg per week of CTAP101 extended release (ER) Capsules versus placebo in raising mean serum total 25-hydroxyvitamin D (25D) to ≥50 ng/mL and in reducing mean plasma intact parathyroid hormone (iPTH) by at least 30% from pre-treatment baseline.
Interventions
- DRUG Placebo oral capsule
- DRUG Calcifediol Oral Capsule
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2018-07-09 |
| Est. Completion | 2021-02-24 |
| Phase | Phase 2 |
Why NCT03602261 stopped before completion
NCT03602261 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (67% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo oral capsule is the first listed.
NCT03602261 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03602261 about?
NCT03602261 is a clinical study titled "Safety, Efficacy, PK and PD of CTAP101 (Calcifediol) ER Capsules for SHPT in HD Patients VDI". Safety, Efficacy, PK and PD of CTAP101 (calcifediol) ER Capsules for SHPT in HD Patients VDI
What is the current status of trial NCT03602261?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 44 participants. The study started on 2018-07-09. Estimated completion is 2021-02-24.
What interventions are being tested in trial NCT03602261?
The interventions under investigation include: Placebo oral capsule (DRUG), Calcifediol Oral Capsule (DRUG).
Who is sponsoring clinical trial NCT03602261?
This trial is sponsored by OPKO Health, which has 32 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03602261's enrollment target sits among peer trials
44 1322nd of 2000 higher than 669 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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