Safety and Efficacy Study of Lusutrombopag for Thrombocytopenia in Patients With Chronic Liver Disease Undergoing Elective Invasive Procedures

NCT02389621 | Completed Phase 3 Results DMC

• 2 other identifiers: 1423M06342014-004942-91
• Study Type: interventional
• Target: 215
• Locations: 0 countries
• Sites: N/A

Brief Summary

The primary purpose of this study is to compare the efficacy of lusutrombopag with placebo for the treatment of thrombocytopenia in patients with chronic liver disease who are undergoing elective invasive procedures.

Conditions

Chronic Liver Disease; Thrombocytopenia

Keywords

Elective invasive procedures

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Required No Platelet Transfusion Prior to the Primary Invasive Procedure and No Rescue Therapy For Bleeding From Randomization Through 7 Days After the Primary Elective Procedure

  Participants were considered as meeting the primary endpoint if all of the following conditions were satisfied: * Required no platelet transfusion from the date of randomization through at least 7 days after the primary invasive procedure * Did not receive the following rescue therapy for bleeding from the date of randomization through 7 days after the primary invasive procedure * Platelet preparations * Other blood preparations, including red blood cells and plasma * Volume expanders * Underwent an invasive procedure. Participants who received at least one platelet transfusion prior to the primary invasive procedure, received at least one rescue therapy for bleeding from the date of randomization through 7 days after the primary invasive procedure, discontinued from the study before undergoing the primary invasive procedure, or did not undergo an invasive procedure were considered as not meeting the primary endpoint.

  From Randomization to 7 days after the invasive procedure, up to approximately 21 days.

Secondary Outcomes (12)

• Percentage of Participants Who Required no Platelet Transfusion During the Study

  From Day 1 to end of the posttreatment period, 35 days.

• Percentage of Participants With a Response

  From Day 1 to the end of the posttreatment period, 35 days.

• Duration of Increase in Platelet Count to ≥ 50 × 10⁹/L

  From Day 1 to the end of the posttreatment period, 35 days.

• Duration of Increase in Platelet Count to ≥ 50 × 10⁹/L by Platelet Transfusion Status

  From Day 1 to the end of the posttreatment period, 35 days.

• Percentage of Participants Who Required Rescue Therapy for Bleeding During the Study

  From Day 1 to the end of the possttreatment period, 35 days.

Study Arms (2)

Lusutrombopag

EXPERIMENTAL

Lusutrombopag 3 mg once daily for up to 7 days.

Drug: Lusutrombopag

Placebo

PLACEBO COMPARATOR

Placebo once daily for up to 7 days.

Drug: Placebo

Interventions

Lusutrombopag DRUG

Tablets for oral administration

Also known as: S-888711

Lusutrombopag

Placebo DRUG

Tablets for oral administration

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able to understand the study and comply with all study procedures.
• Willing to provide written informed consent prior to Screening.
• Male or female.
• years of age or older at the time of signing informed consent.
• Platelet count \< 50 × 10\^9/L at baseline on Day 1 prior to randomization.
• Undergoing an elective invasive procedure.
• In the opinion of the investigator, able to meet study requirements.
• Male patients who are sterile or who agree to use an appropriate method of contraception (including use of a condom with spermicide) from Screening to completion of the Post-treatment Period.
• Female patients who are not postmenopausal or surgically sterile need to agree to use a highly effective contraception (including contraceptive implant, injectable contraceptive, combination hormonal contraceptive \[including vaginal rings\], intrauterine contraceptive device or vasectomised partner) from Screening to completion of the Post-treatment Period. Barrier method with or without spermicide, double barrier contraception and oral contraceptive pill are insufficient methods on their own.

You may not qualify if:

• Any of the following diseases:
• hematopoietic tumor
• aplastic anemia
• myelodysplastic syndrome
• myelofibrosis
• congenital thrombocytopenia
• drug-induced thrombocytopenia
• generalized infection requiring treatment except for viral liver disease
• immune thrombocytopenia.
• History of splenectomy.
• History of liver transplantation.
• Any of the following at Screening:
• hepatic encephalopathy uncontrolled by drugs
• ascites uncontrolled by drugs.
• Portal vein tumor embolism.

Sponsors & Collaborators

• Shionogi: lead

Related Publications (2)

• Flamm SL, Peck-Radosavljevic M, Fukuhara T, Bentley R, Katsube T, Ochiai T, Kano T, Tsukimura E, Sasaki R, Osaki Y. Pharmacokinetic Assessment and Treatment Effect of Lusutrombopag in Child-Pugh Class C Patients: Review of Patient Data from Two Clinical Studies and Post-Marketing Surveillance. Adv Ther. 2022 Sep;39(9):4285-4298. doi: 10.1007/s12325-022-02237-8. Epub 2022 Jul 29.

  PMID: 35904722 DERIVED

• Alkhouri N, Imawari M, Izumi N, Osaki Y, Ochiai T, Kano T, Bentley R, Trevisani F. Lusutrombopag Is Safe and Efficacious for Treatment of Thrombocytopenia in Patients With and Without Hepatocellular Carcinoma. Clin Gastroenterol Hepatol. 2020 Oct;18(11):2600-2608.e1. doi: 10.1016/j.cgh.2020.03.032. Epub 2020 Mar 20.

  PMID: 32205226 DERIVED

MeSH Terms

Conditions

Thrombocytopenia

Interventions

lusutrombopag

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia

Results Point of Contact

• Title: Shionogi Clinical Trials Administrator
• Organization: Shionogi Inc.

shionogiclintrials-admin@shionogi.co.jp

800-849-9707

Study Officials

• Shionogi Clinical Trials Administrator Clinical Support Help Line

  Shionogi

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2015
• First Posted: March 17, 2015
• Study Start: June 15, 2015
• Primary Completion: April 5, 2017
• Study Completion: April 19, 2017
• Last Updated: October 30, 2018
• Results First Posted: September 25, 2018

Record last verified: 2018-10