Avatrombopag for the Treatment of Thrombocytopenia in Adults With Chronic Liver Disease Undergoing a Procedure

• Sponsor: Sobi, Inc. (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT03554759
• Collaborator: (none)
• Enrollment: 50
• Locations: 41
• Actual Duration (Months): 7
• Patients Per Site: 1.2
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

Phase 4 observational cohort study to characterize the treatment patterns and effects of avatrombopag use in patients with thrombocytopenia associated with chronic liver disease who are either undergoing, or have already undergone, a procedure.

Condition or Disease	Intervention/Treatment	Phase
Thrombocytopenia	Drug: Avatrombopag

Detailed Description

Data (e.g. type of procedure, platelet count, etc.) will be collected retrospectively or prospectively from patient visits occurring within approximately 7 calendar days prior to the first dose of avatrombopag, on Procedure Day, on Discharge Day, and from any clinic visit performed up to 30 days post-procedure. All treatment decisions and clinical assessments will be at the discretion of the treating physician per routine medical care and are not mandated by study design or protocol.

Study Design

• Study Type: Observational
• Actual Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: An Observational Cohort Study of the Use of Avatrombopag in Patients With Thrombocytopenia Associated With Chronic Liver Disease Undergoing a Procedure
• Actual Study Start Date: Jul 2, 2018
• Actual Primary Completion Date: Jan 31, 2019
• Actual Study Completion Date: Jan 31, 2019

Outcome Measures

Primary Outcome Measures

1. Change in platelet count [Up to 8 days after the last dose of avatrombopag.]

Secondary Outcome Measures

1. Proportion of patients who received a platelet transfusion [From the first dose of avatrombopag to up to 15 days after the last dose of avatrombopag]

2. Occurrence of adverse events [From the first dose of avatrombopag to up to 30 days after the last dose of avatrombopag]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

Inclusion Criteria:

• Patient has thrombocytopenia associated with chronic liver disease and is planned for or underwent treatment with avatrombopag prior to a procedure

• Patient provides written informed consent

Minimum Data for Retrospective Enrollment

• Platelet count from approximately 7 days prior to starting avatrombopag

• Platelet count on Procedure Day

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dova Site	Chandler	Arizona	United States	85224
2	Dova Site	Lancaster	California	United States	93534
3	Dova Study Site	Los Angeles	California	United States	90048
4	Dova Site	Palm Springs	California	United States	92262
5	Dova Study Site	Pasadena	California	United States	91107
6	Dova Study Site	San Clemente	California	United States	92673
7	Dova Study Site	San Diego	California	United States	92114
8	Dova Study Site	San Diego	California	United States	92121
9	Dova Study Site	Aurora	Colorado	United States	80045
10	Dova Study Site	Englewood	Colorado	United States	80113
11	Dova Study Site	Gainesville	Florida	United States	32610
12	Dova Study Site	Miami	Florida	United States	33136
13	Dova Study Site	Atlanta	Georgia	United States	30309
14	Dova Study Site	Topeka	Kansas	United States	66606
15	Dova Study Site	Louisville	Kentucky	United States	40202
16	Dova Study Site	Baltimore	Maryland	United States	21202
17	Dova Study Site	Boston	Massachusetts	United States	02215
18	Dova Study Site	Burlington	Massachusetts	United States	01805
19	Dova Study Site	Worcester	Massachusetts	United States	01655
20	Dova Study Site	Ann Arbor	Michigan	United States	48109
21	Dova Study Site	Detroit	Michigan	United States	48239
22	Dova Site	Jackson	Mississippi	United States	39216
23	Dova Study Site	New Brunswick	New Jersey	United States	08901
24	Dova Study Site	Bronx	New York	United States	10467
25	Dova Study Site	Manhasset	New York	United States	11030
26	Dova Study Site	New York	New York	United States	10016
27	Dova Study Site	Durham	North Carolina	United States	27710
28	Dova Study Site	Cleveland	Ohio	United States	44016
29	Dova Study Site	Columbus	Ohio	United States	43210
30	Dova Study Site	Flourtown	Pennsylvania	United States	19031
31	Dova Site	Philadelphia	Pennsylvania	United States	19141
32	Dova Study Site	Pittsburgh	Pennsylvania	United States	15213
33	Dova Study Site	Johnson City	Tennessee	United States	37604
34	Dova Study Site	Memphis	Tennessee	United States	38104
35	Dova Study Site	Union City	Tennessee	United States	38261
36	Dova Study Site	Dallas	Texas	United States	75234
37	Dova Study Site	Houston	Texas	United States	77030
38	Dova Study Site	Charlottesville	Virginia	United States	22908
39	Dova Study Site	Richmond	Virginia	United States	23226
40	Dova Study SIte	Roanoke	Virginia	United States	24014
41	Dova Study Site	Milwaukee	Wisconsin	United States	53226

Sponsors and Collaborators

• Sobi, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sobi, Inc.
• ClinicalTrials.gov Identifier: NCT03554759
• Other Study ID Numbers: AVA-CLD-401
• First Posted: Jun 13, 2018
• Last Update Posted: Mar 8, 2019
• Last Verified: Jul 1, 2018

• Studies a U.S. FDA-regulated Drug Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Sobi, Inc.: Chronic Liver Disease; Low Platelet Count
• Additional relevant MeSH terms: Liver Diseases; Thrombocytopenia

Study Results

No Results Posted as of Mar 8, 2019