Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01389973 · ClinicalTrials.gov registry record · Phase 2
A Study of Efficacy and Safety of Ustekinumab in Patients With Primary Biliary Cirrhosis (PBC) Who Had an Inadequate Response to Ursodeoxycholic Acid
A Phase 2 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT01389973 is a Phase 2 study that has completed, run by Janssen Research & Development. The registered enrollment target is 20 participants.
The verdict
NCT01389973, a Phase 2 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study Summary
The purpose of this study is to evaluate the efficacy and safety of ustekinumab in patients with primary biliary cirrhosis who had an inadequate response to ursodeoxycholic acid.
Interventions
- DRUG Placebo
- DRUG ustekinumab 90 mg
- DRUG ustekinumab 45 mg
- DRUG ustekinumab 180 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2011-09 |
| Est. Completion | 2013-06 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01389973
The ClinicalTrials.gov registry entry for NCT01389973 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01389973 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01389973 about?
NCT01389973 is a clinical study titled "A Study of Efficacy and Safety of Ustekinumab in Patients With Primary Biliary Cirrhosis (PBC) Who Had an Inadequate Response to Ursodeoxycholic Acid". The purpose of this study is to evaluate the efficacy and safety of ustekinumab in patients with primary biliary cirrhosis who had an inadequate response to ursodeoxycholic acid.
What is the current status of trial NCT01389973?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2011-09. Estimated completion is 2013-06.
What interventions are being tested in trial NCT01389973?
The interventions under investigation include: Placebo (DRUG), ustekinumab 90 mg (DRUG), ustekinumab 45 mg (DRUG), ustekinumab 180 mg (DRUG).
Who is sponsoring clinical trial NCT01389973?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.