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NCT00570765 · ClinicalTrials.gov registry record · Phase 2

Study of INT-747 as Monotherapy in Participants With Primary Biliary Cirrhosis (PBC)

A Phase 2 study, sponsored by Intercept Pharmaceuticals.

Completed
Registry status
Phase 2
Development phase
60
Enrollment target

NCT00570765 is a Phase 2 study that has completed, run by Intercept Pharmaceuticals. The registered enrollment target is 60 participants.

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The verdict

NCT00570765, a Phase 2 study, has completed, sponsored by Intercept Pharmaceuticals.

COMPLETED
Registry status
Phase 2
Development phase
60 participants
Enrollment target

Study Summary

The primary hypothesis was that obeticholic acid (OCA) will cause a reduction in alkaline phosphatase levels in PBC participants, over a 12-week treatment period, as compared to placebo.

Interventions

  • DRUG Placebo
  • DRUG Obeticholic Acid (OCA)

Trial Details

FieldValue
Enrollment Target 60 participants
Start Date 2008-01-17
Est. Completion 2017-09-25
Phase Phase 2

Sponsor

Intercept Pharmaceuticals

18 total trials

What the Registry Record Tells You About NCT00570765

The ClinicalTrials.gov registry entry for NCT00570765 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Intercept Pharmaceuticals, which has 18 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT00570765 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00570765 about?

NCT00570765 is a clinical study titled "Study of INT-747 as Monotherapy in Participants With Primary Biliary Cirrhosis (PBC)". The primary hypothesis was that obeticholic acid (OCA) will cause a reduction in alkaline phosphatase levels in PBC participants, over a 12-week treatment period, as compared to placebo.

What is the current status of trial NCT00570765?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2008-01-17. Estimated completion is 2017-09-25.

What interventions are being tested in trial NCT00570765?

The interventions under investigation include: Placebo (DRUG), Obeticholic Acid (OCA) (DRUG).

Who is sponsoring clinical trial NCT00570765?

This trial is sponsored by Intercept Pharmaceuticals, which has 18 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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.