Chronic Hepatitis C Virus Related Thrombocytopenia to Evaluate the Effects of E5501

NCT01355289 | Completed Phase 2 Results DMC

• 1 other identifier: E5501-G000-203
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 2

Brief Summary

To evaluate the efficacy of E5501 by measuring platelet response in subjects with chronic hepatitis C virus (HCV)-related thrombocytopenia who require antiviral treatment.

Conditions

Thrombocytopenia

Keywords

Chronic Hepatitis C related

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Achieved Platelet Response (Greater Than or Equal to 100 x 10^9/L) by Day 21 of Treatment Period A1 of Core Study

  A responder was defined as a participant having a platelet count of greater than or equal to 100x10\^9/L by Day 21 starting from an average baseline platelet count of greater than 20 x 10\^9/L to less than or equal to 70 x 10\^9/L.

  Baseline to Day 21

Secondary Outcomes (3)

• Change From Baseline of Local Platelet Count by Visit During Treatment Period A1 of Core Study

  Day 7 and Day 14

• Number of Participants Who Achieved Platelet Count Greater Than 30 X 10^9/L From Baseline to Day 21 During Treatment Period A1 of Core Study

  Baseline to Day 21

• Number of Participants Who Initiated Antiviral Treatment by Day 21 of Period A1 of Core Study

  Baseline to Day 21

Study Arms (5)

Placebo (Core Study)

PLACEBO COMPARATOR

Placebo, will be administered orally, once daily for up to 21 days.

Drug: Placebo

Avatrombopag 10 mg (Core Study)

ACTIVE COMPARATOR

Avatrombopag 10 mg, will be administered orally, once daily, preferably with food for up to 21 days.

Drug: Avatrombopag

Avatrombopag 20 mg (Core Study)

ACTIVE COMPARATOR

Avatrombopag 20 mg, will be administered orally, once daily, preferably with food for up to 21 days.

Drug: Avatrombopag; Drug: Pegylated interferon (PEG-IFN); Drug: Telaprevir; Drug: Ribavirin

Avatrombopag 30 mg (Core Study)

ACTIVE COMPARATOR

Avatrombopag 30 mg, will be administered orally, once daily, preferably with food for up to 21 days.

Drug: Avatrombopag

Avatrombopag (Open-Label Extension)

EXPERIMENTAL

Avatrombopag will be initiated at a dose of 20 mg, once daily in the open-label extension (OLE) period. The avatrombopag dose will be titrated up or down in accordance with the participant's individual response, within the range of a minimum of 5 mg and a maximum of 50 mg for up to 48 weeks.

Drug: Avatrombopag; Drug: Pegylated interferon (PEG-IFN); Drug: Telaprevir; Drug: Ribavirin

Interventions

Avatrombopag DRUG

Also known as: E5501, Avatrombopag maleate

Avatrombopag (Open-Label Extension); Avatrombopag 10 mg (Core Study); Avatrombopag 20 mg (Core Study); Avatrombopag 30 mg (Core Study)

Placebo DRUG

Placebo (Core Study)

Pegylated interferon (PEG-IFN) DRUG

Participants in Treatment Periods A2, B2, and B3 are to receive antiviral treatment PEG-IFN, ribavirin, or telaprevir. Provided by the sponsor.

Avatrombopag (Open-Label Extension); Avatrombopag 20 mg (Core Study)

Telaprevir DRUG

Participants in Treatment Periods A2, B2, and B3 are to receive antiviral treatment PEG-IFN, ribavirin, or telaprevir. Provided by the sponsor

Also known as: Incivek, Incivo

Avatrombopag (Open-Label Extension); Avatrombopag 20 mg (Core Study)

Ribavirin DRUG

Participants in Treatment Periods A2, B2, and B3 are to receive antiviral treatment PEG-IFN, ribavirin, or telaprevir. Provided by the sponsor

Also known as: Virazole, Rebetol, Copegus, Ribasphere, Moderiba dose pack, Moderiba

Avatrombopag (Open-Label Extension); Avatrombopag 20 mg (Core Study)

Eligibility Criteria

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

You may qualify if:

• Males or females greater than or equal to 18 years of age
• Women of childbearing potential must agree to use a highly effective method of contraception for at least one menstrual cycle prior to starting study drug, throughout the entire study period, and for 30 days after the last dose of study drug
• Subjects with chronic HCV-related thrombocytopenia (defined as a platelet count greater than or equal to 20x10\^9/L to 70x10\^9/L) who require antiviral treatment
• Chronic HCV infection (defined as the presence of anti-HCV antibodies and detectable serum HCV RNA levels)
• Model for End-stage Liver disease score greater than or equal to 24
• Adequate renal function as evidenced by a calculated creatinine clearance greater than or equal to 50 mL/minute per the Cockcroft and Gault formula
• Life expectancy greater than or equal to 3 months

You may not qualify if:

• Any history of arterial or venous thrombosis, including partial or complete thrombosis (e.g., stroke, transient ischemic attack, myocardial infarction, deep vein thrombosis or pulmonary embolism), thrombosis (partial or complete) in the main portal vein and portal vein branches, and thrombosis of any part of the splenic-mesenteric system
• Any evidence of current portal vein thrombosis (PVT) as detected by Doppler sonography and portal vein flow rate less than 15 cm/second at Screening or within 30 days prior to Screening (revised per Amendment 02)
• Any known family history of hereditary thrombophilic disorders (e.g., Factor V Leiden, antithrombin III deficiency)
• Evidence of myocardial infarction in the last 6 months or uncompensated congestive heart failure (New York Heart Association Class III or IV)
• Co-infection with human immunodeficiency virus (HIV) or hepatitis B or acute hepatitis C
• Any prohibited concomitant medications or therapy that cannot be discontinued by Visit 1, e.g., subjects currently receiving interferon who cannot undergo a 4-week washout period prior to Screening, or subjects who receive blood products that affect platelet count within 1 week prior to Screening (revised per Amendment 02)
• Weekly alcohol intake greater than 21 units (168 g) \[male\] and greater than 14 units (112 g) \[female\]
• Any known medical condition, other than chronic liver disease, that can lead to thrombocytopenia
• History of hepatocellular carcinoma, metastatic liver cancer, or liver transplantation (revised per Amendment 01) (revised per Amendment 02)
• History of idiopathic thrombocytopenic Purpura (ITP)
• History of myelodysplastic syndrome
• History of pernicious anemia or subjects with vitamin B12 deficiency (defined as less than the lower limit of normal \[LLN\]) who have not had pernicious anemia excluded as a cause (Added per Amendment 02)
• Evidence of clinically significant disease (e.g., cardiac, respiratory, gastrointestinal, renal disease) that, in the opinion of the investigator, could affect the subject's safety or study conduct
• Subjects with a history of suicide attempts
• Subjects with a history of hospitalization for depression within the past 5 years

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (2)

Health Care Consultants

Los Angeles, California, United States

Location

Metropolitan Research

Fairfax, Virginia, 22031, United States

Location

MeSH Terms

Conditions

Thrombocytopenia

Interventions

avatrombopag; telaprevir; Ribavirin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Ribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Eisai Inc.
• Organization: Eisai Call Center

888-422-4743

Study Officials

• Alireza Manhuchehri

  Eisai Inc.

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2011
• First Posted: May 18, 2011
• Study Start: November 1, 2011
• Primary Completion: February 1, 2014
• Study Completion: May 1, 2014
• Last Updated: February 22, 2018
• Results First Posted: February 22, 2018

Record last verified: 2018-01

Locations

US (2)