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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: Completed Phase 3 study, sponsored by Eisai.
NCT01976104 is a Phase 3 study that has completed, run by Eisai. The registered enrollment target is 204 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
Responders were defined as participants who did not require a platelet transfusion or any rescue procedure for bleeding after randomization and up to 7 days following a scheduled procedure. Participants with missing information due to early withdrawal or other reasons were conservatively considered as having received a transfusion in the analysis, (i.e. a Non-responder).
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 |
What the finished NCT01976104 record still lists
NCT01976104 is an interventional study that assigns participants to a tested intervention. The registered 204 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 4 interventions - of which avatrombopag (lower baseline platelet count) is the first listed.
NCT01976104 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01976104's enrollment target sits among peer trials
204 1352nd of 2000 higher than 649 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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