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NCT01976104 · ClinicalTrials.gov registry record · Phase 3
Treatment of Thrombocytopenia in Patients With Chronic Liver Disease Undergoing an Elective Procedure
A Phase 3 study, sponsored by Eisai.
- Completed
- Registry status
- Phase 3
- Development phase
- 204
- Enrollment target
NCT01976104 is a Phase 3 study that has completed, run by Eisai. The registered enrollment target is 204 participants.
The verdict
NCT01976104, a Phase 3 study, has completed, sponsored by Eisai.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 204 participants
- Enrollment target
Study Summary
This is a global, multicenter, randomized, double-blind, placebo-controlled, parallel group study using avatrombopag to treat adults with thrombocytopenia associated with liver disease. The study will evaluate avatrombopag in the treatment of thrombocytopenia associated with liver disease prior to an elective procedure to reduce the need for platelet transfusions or any rescue procedure for bleeding due to procedural and post-procedural bleeding complications. Participants will be enrolled into 2 cohorts according to mean baseline platelet count and, within each baseline platelet count cohort will be further stratified by risk of bleeding associated with the elective procedure (low, moderate, or high) and hepatocellular carcinoma (HCC) status (Yes or No).
Interventions
- DRUG avatrombopag (lower baseline platelet count)
- DRUG placebo (lower baseline platelet count)
- DRUG avatrombopag (higher baseline platelet count)
- DRUG placebo (higher baseline platelet count)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 204 participants |
| Start Date | 2013-11 |
| Est. Completion | 2017-02-21 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01976104
The ClinicalTrials.gov registry entry for NCT01976104 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 204 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Eisai, which has 287 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which avatrombopag (lower baseline platelet count) is the first listed.
NCT01976104 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01976104 about?
NCT01976104 is a clinical study titled "Treatment of Thrombocytopenia in Patients With Chronic Liver Disease Undergoing an Elective Procedure". This is a global, multicenter, randomized, double-blind, placebo-controlled, parallel group study using avatrombopag to treat adults with thrombocytopenia associated with liver disease. The study will evaluate avatrombopag in the treatment of thrombocytopenia associated with liver disease prior to a...
What is the current status of trial NCT01976104?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 204 participants. The study started on 2013-11. Estimated completion is 2017-02-21.
What interventions are being tested in trial NCT01976104?
The interventions under investigation include: avatrombopag (lower baseline platelet count) (DRUG), placebo (lower baseline platelet count) (DRUG), avatrombopag (higher baseline platelet count) (DRUG), placebo (higher baseline platelet count) (DRUG).
Who is sponsoring clinical trial NCT01976104?
This trial is sponsored by Eisai, which has 287 total clinical trials registered on ClinicalTrials.gov.
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