Phase 3
N=204
Treatment of Thrombocytopenia in Patients With Chronic Liver Disease Undergoing an Elective Procedure
Thrombocytopenia Associated With Liver Disease
Bottom Line
View on ClinicalTrials.gov: NCT01976104 ↗Enrolled (actual)
204
Serious AEs
2.0%
Results posted
Feb 2018
Primary outcome: Primary: Percentage of Participants Who Did Not Require a Platelet Transfusion After Randomization and up to 7 Days Following a Scheduled Procedure — 34.9; 68.6; 33.3; 87.9 Percentage of participants — p==0.0006
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- avatrombopag (lower baseline platelet count) (Drug); placebo (lower baseline platelet count) (Drug); avatrombopag (higher baseline platelet count) (Drug); placebo (higher baseline platelet count) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eisai Inc.
- Primary completion
- Jan 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Did Not Require a Platelet Transfusion After Randomization and up to 7 Days Following a Scheduled Procedure |
34.9; 68.6; 33.3; 87.9 | =0.0006 sig |
| SECONDARY Percentage of Participants Who Achieved a Platelet Count Greater Than or Equal to 50 x 10^9/L on Scheduled Procedure Day |
7.0; 67.1; 39.4; 93.1 | <0.0001 sig |
| SECONDARY Change From Baseline in Platelet Counts on Scheduled Procedure Day |
3.0; 31.3; 5.9; 44.9 | <0.0001 sig |
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).
Eligibility Criteria
Inclusion Criteria
- Participants greater than or equal to 18 years of age at Screening with chronic liver disease
- Participants who have a mean baseline platelet count of less than 50 x 10^9/L. Platelet counts must be measured on 2 separate occasions, during the Screening Period and at Baseline, and must be performed at least one day apart with neither platelet count greater than 60 x 10^9/L. The mean of these 2 platelet counts (mean baseline platelet count) will be used for entry criteria and for assignment to the low or high baseline platelet count cohort.
- Participants scheduled to undergo a permitted elective procedure who, in the opinion of the investigator, will require a platelet transfusion to address a risk of bleeding associated with the procedure unless there is a clinically significant increase in platelet count from baseline
- Model For End-stage Liver Disease (MELD) score less than or equal to 24 at Screening
- If taking inhibitors of P glycoprotein (P-gp), except for verapamil, dose must be stable for 7 days prior to Screening
- Provide written informed consent
- Willing and able to comply with all aspects of the protocol
Exclusion Criteria
- Any history of arterial or venous thrombosis, including partial or complete thrombosis
- Evidence of thrombosis (partial or complete) in the main portal vein, portal vein branches, or any part of the splenic mesenteric system at Screening
- Portal vein blood flow velocity rate 15 for women at Screening, with hematocrit ≥ 54% for men and ≥ 45% for women
- Current malignancy including solid tumors and hematologic malignancies (except HCC)
- Any history of concomitant medical condition that, in the opinion of the investigator(s), would compromise the participant's ability to safely complete the study
- Currently enrolled in another clinical trial with any investigational drug or device within 30 days of Screening
Data sourced from ClinicalTrials.gov (NCT01976104). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.