Study of Quadruple Therapy With Eltrombopag for Chronic Hepatitis C

NCT01821625 | Terminated Phase 2 Results

• 1 other identifier: STU 032013-020
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

This study will provide chronic hepatitis C patients with low platelets (less than 75x10\^9/L) the opportunity to undergo treatment and possible cure of their virus. The main hepatitis C drugs will be administered as standard of care, with the addition of the study drug eltrombopag. The investigators hypothesize that providing eltrombopag to chronic hepatitis C patients with low platelets (less than 75x10\^9/L) will permit the initiation and completion of antiviral triple therapy with boceprevir, ribavirin, and pegylated-interferon.

Conditions

Thrombocytopenia; Hepatitis C

Keywords

Thrombocytopenia; Hepatitis; Platelets; Eltrombopag; Liver Disease; Antiviral Treatment

Outcome Measures

Primary Outcomes (1)

• Percentage of Study Patients Completing Antiviral Therapy, as Per Boceprevir Prescribing Guidelines.

  The length of therapy will depend on several factors: 1. Study patient's liver disease status. 2. Study patient's antiviral response. 3. Study patient's tolerance to treatment. One patient completed therapy and experienced a sustained viral response. A minimum full course of treatment will be 30 weeks, with a maximum of 56 weeks of treatment.

  Up to 56 weeks

Study Arms (1)

Thrombocytopenic (Low Platelet) Patients

EXPERIMENTAL

All study patients will undergo intervention in this study. The intervention will be a lead-in with eltrombopag and antiviral triple therapy (interferon, ribavirin and boceprevir).

Drug: Eltrombopag

Interventions

Eltrombopag DRUG

Study patients will be provided eltrombopag to raise platelet levels before anti-hepatitis C drugs are initiated, and will continue eltrombopag throughout the study.

Also known as: Promacta

Thrombocytopenic (Low Platelet) Patients

Eligibility Criteria

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

You may qualify if:

• Male and female patients at least 18 years of age.
• Require a platelet count below 75 x 10\^9 /L at time of screening.
• The patients must meet the eligibility criteria for all drugs involved.
• Only genotype 1 (a, b, indeterminate, or mixed).
• Confirmed history of chronic hepatitis C.
• Cirrhotic patients will be included.
• Liver imaging within 1 year to exclude hepatocellular carcinoma (HCC) is required in patients with cirrhosis.
• Patients without evidence of cirrhosis but meeting platelet criteria will also be admitted to study.
• Subjects must be able to provide informed consent, comply with drug administration instructions, and be able to complete each study visit.
• Ability to cover costs of ribavirin, interferon, and boceprevir will also be required.
• Female subjects are eligible if: Non-pregnant, non-childbearing potential, or of childbearing potential and willing to perform complete abstinence or correctly use a form of birth control during intercourse \[barrier method, intrauterine device, hormonal therapy, or surgical sterilization in females or male partner\]. They must also be willing to have pregnancy tests performed every 4- weeks until 6 months after completion of ribavirin.
• Male study participants must agree to use a condom and their female partner must partake in one of the contraceptive methods discussed above until 6 months after completion of ribavirin therapy.

You may not qualify if:

• A history of chronic infection (i.e., HIV or HBV) or a previous organ transplantation.
• A history of a platelet disorder.
• A poorly controlled underlying medical illness (i.e., diabetes, hypertension, coronary artery disease, congestive heart failure, etc.).
• Any contraindication to any study drugs as mentioned in their respective prescribing information.
• Patients with decompensated cirrhosis defined as current evidence for ascites, encephalopathy, infection or variceal bleeding. All patients should be considered Child-Pugh Class A.
• Patients with aminotransferase levels ≥ 500 IU/L will be excluded on presumption of another active liver disease.
• Patients must not be pregnant or nursing.
• The study physician maintains the right to exclude a patient for a medical condition not listed above or based off laboratory values indicating chronic disease discovered at screening.
• Patients with eye disease may be excluded from this study if the ophthalmologist does not recommend treatment.
• Subjects with known hypersensitivity reactions (such as Stevens-Johnson syndrome, toxic, epidermal necrolysis, and erythema multiforme to ribavirin) to study drugs or any component of the products.
• Subjects with autoimmune hepatitis, hemoglobinopathies (e.g., thalassemia major, sickle-cell anemia), creatinine clearance less than 50 mL/min.
• Co-administration of drugs that are highly dependent on CYP3A4/5 for clearance and CYP3A4/5 inducers (See Table 2 in boceprevir prescribing information).

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390-8887, United States

Location

MeSH Terms

Conditions

Thrombocytopenia; Hepatitis C; Hepatitis; Liver Diseases

Interventions

eltrombopag

Condition Hierarchy (Ancestors)

Blood Platelet Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Cytopenia; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Digestive System Diseases

Results Point of Contact

• Title: William M Lee, MD
• Organization: UT Southwestern Medical Center at Dallas

william.lee@utsouthwestern.edu

214 645 6111

Study Officials

• William M Lee, M.D.

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2013
• First Posted: April 1, 2013
• Study Start: April 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2016
• Last Updated: November 13, 2019
• Results First Posted: October 22, 2019

Record last verified: 2019-10

Locations

US (1)