Treating Hispanic Patients Diagnosed With Hepatitis C Using Boceprevir

NCT ID: NCT01465516

Last Updated: 2015-06-30

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 105 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2013-12-31

Brief Summary

Hypothesis Response guided therapy improves significantly the overall SVR in Hispanics compared to historical control. There is no difference in SVR between patients with an undetectable HCV RNA at week 8 and week 28 who received a 4 week lead-in of PR plus 24 weeks of PR+BOC based treatment and patients with detectable HCV RNA at week 8 and undetectable HCV RNA at week 24 who received a lead-in of PR plus 32 weeks PR+BOC followed by based therapy and 12 weeks of PR.

Detailed Description

STUDY DESIGN AND ENROLLMENT Open label single arm pilot study enrolling Hispanic patients with HCV genotype 1 and naive to pegylated interferon and BOC treatment.

Definition of BOC RGT:

All patients will receive 4 weeks of PR (lead-in), and BOC will be added at the beginning of week 5. Patients who have an undetectable HCV RNA at week 8 and week 24 will receive 24 weeks of PR and BOC (28 weeks total treatment); patients who have a detectable HCV RNA at week 8, but an undetectable HCV RNA at week 24, will receive an additional 32 weeks of PR and BOC, followed by 12 weeks of PR (48 weeks total treatment).

Patients with cirrhosis or bridging fibrosis (Stage 4 fibrosis) will receive 4 weeks of lead in followed by 44 weeks of BOC and PR (total 48 weeks).

Conditions

Hepatitis C Infection

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Hispanic, HCV genotype 1

Historical group will be a continuous group of Hispanic patients with genotype 1 who were naive to treatment and completed or initiated 48 weeks of pegylated interferon and ribavirin. Patients, who discontinued the treatment due to side effects, adherence issues, or treatment failure, will be included and analyzed based on intention to treat analysis. All patients will be stratified according to their SVR, relapse and no response rate. RVR, EVR, and ETR will be also collated and compared to the study group.

Boceprevir

Intervention Type: DRUG

Baseline assessments must be obtained on the day of or prior to enrollment and prior to administration of the first dose of any study drug (BOC, PEG-IFN alfa-2b, or ribavirin).

Using the RGT guidelines in patients who are previously untreated: all patients will receive a lead-in treatment of PR for 4 weeks, then BOC will be added to PR for 4 weeks; based on patient's week 8 HCV RNA results

Interventions

Boceprevir

Baseline assessments must be obtained on the day of or prior to enrollment and prior to administration of the first dose of any study drug (BOC, PEG-IFN alfa-2b, or ribavirin).

Using the RGT guidelines in patients who are previously untreated: all patients will receive a lead-in treatment of PR for 4 weeks, then BOC will be added to PR for 4 weeks; based on patient's week 8 HCV RNA results

Intervention Type: DRUG

Other Intervention Names

Victrelis

Eligibility Criteria

Inclusion Criteria

To be eligible for this trial, patients must have documentation of the following:

• Male or female > 18 years old
• HCV genotype-1 infection
• Liver biopsy consistent with Chronic Hepatitis C (CHC) within the last 3 years
• No previous treatment with any anti-HCV therapy (approved or investigational)
• For women of childbearing potential, a negative urine pregnancy test result documented within 24 hours prior to the first dose of any study drug (BOC, PEG-INF alfa-2b, or ribavirin). Additionally, all female patients of childbearing potential and all males with female partners of childbearing potential must use two forms of effective contraception (combined) during study treatment and for 6 months after treatment.
• Willingness to give written informed consent and to participate in and comply with requirements of the study

Exclusion Criteria

Patients with any of the following will not be eligible for participation:

• Infection with HCV other than genotype 1
• History or other evidence of a medical condition associated with chronic liver disease other than CHC (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
• History or other evidence of decompensated liver disease (e.g., coagulopathy, hyperbilirubinemia, hepatic encephalopathy, hypoalbuminemia, ascites, bleeding from esophageal varices) or a Child-Pugh score > 6 (see Appendix 1)
• Infection with hepatitis A virus (HAV), hepatitis B virus (HBV), or HIV as demonstrated by a positive test at screening for anti-HAV immunoglobulin M (IgM) antibodies (Ab), hepatitis B surface antigen, anti-hepatitis B core protein IgM Ab, or anti-HIV antibodies
• History of having received IFN, PEG-IFN, ribavirin, viramidine, levovirin, or investigational HCV protease or polymerase inhibitors at any previous time, or any other systemic antiviral therapy with established or perceived activity against HCV within 3 months prior to enrollment.
• Pregnant or breastfeeding
• Male partners of females who are pregnant or breastfeeding
• Hemoglobin concentration < 12 g/dL in females or < 13 g/dL in males or any patient with an increased risk for anemia (e.g., thalassemia, sickle cell anemia, spherocytosis, history of gastrointestinal bleeding) or for whom anemia would be medically problematic
• Absolute neutrophil count (ANC) < 1000 cells/mm3
• Platelet count < 70,000 cells/mm3
• Receipt of stimulating factors such as granulocyte colony stimulating factor (G-CSF), erythropoietin, or other therapeutic agents to elevate hematology parameters to facilitate patient entry into the study
• Serum creatinine concentration > 1.5 times the upper limit of normal (ULN)
• History of severe psychiatric disease, including psychosis and/or depression, characterized by a suicide attempt, hospitalization for psychiatric disease, or a period of disability as a result of psychiatric disease
• Poorly controlled thyroid dysfunction
• History of cardiac disease (e.g., New York Heart Association functional class II, III, or IV, myocardial infarction within the last 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina, or other significant cardiovascular diseases. In addition, patients with documented or presumed coronary artery disease or cerebrovascular disease should not be enrolled if, in the judgment of the investigator, an acute decrease in hemoglobin by up to 4 g/dL (as may be seen with ribavirin therapy) would not be well tolerated.
• History of uncontrolled severe seizure disorder within the last year
• Patients treated previously with protease or polymerase inhibitors
• Coadministration of drugs that are highly dependent on CYP3A4/5 for clearance, and for which elevated plasma concentrations are associated with serious and/or life-threatening events including those in Appendix 2.
• Coadministration with potent CYP3A4/5 inducers, where significantly reduced boceprevir plasma concentrations may be associated with reduced efficacy.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Arrowhead Regional Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Zeid Kayali, MD

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zeid Kayali, MD

Role: PRINCIPAL_INVESTIGATOR

Southern California Transplantation Institute Research Foundation

Locations

Southern California Transplantation Institute Research Foundation

Riverside, California, United States

Countries

United States

Other Identifiers

38950

Identifier Type: -

Identifier Source: org_study_id