Treating Hispanic Patients Diagnosed With Hepatitis C Using Boceprevir

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01465516
Recruitment Status : Terminated (The study was terminated and recruitment was capped because of the new changes in hepatitis C market)
First Posted : November 4, 2011
Last Update Posted : June 30, 2015
Information provided by (Responsible Party):
Zeid Kayali, MD, Arrowhead Regional Medical Center

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.

Condition or disease Intervention/treatment
Hepatitis C Infection Drug: Boceprevir

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).

Study Type : Observational
Actual Enrollment : 105 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Response Guided Therapy (RGT) for Boceprevir Combined With Peginterferon Alpha-2b Plus Ribavirin in Naïve Hispanic Patients With Genotype 1 Hepatitis C Infection
Study Start Date : November 2011
Actual Primary Completion Date : December 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
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.
Drug: 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

Other Name: Victrelis

Primary Outcome Measures :
  1. SVR based on intention to treat analysis [ Time Frame: 24 weeks ]
    Patients who have detectable HCV RNA at week 24 must have study treatment discontinued.

Secondary Outcome Measures :
  1. Tolerance [ Time Frame: 48 weeks ]

    All patients who have study treatment discontinued should have the assessments scheduled for the end of anti HCV treatment (Week 48) performed at the time of premature discontinuation and the follow-up assessments required 12 weeks after the end of anti HCV therapy.

    If a discontinued patient received greater than or equal to 12 weeks of anti HCV therapy, an HCV test should be performed 24 weeks after the last dose of anti HCV treatment.

  2. BDI II score 31 or above [ Time Frame: 48 weeks ]
    Any patient who has a BDI II score greater than or equal to 31 at any time during the study should have study treatment discontinued.

Biospecimen Retention:   Samples With DNA

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hispanic patients >18 years of age with cirrhosis or bridging fibrosis with Hepatitis C Infection whom are treatment naive.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01465516

United States, California
Southern California Transplantation Institute Research Foundation
Riverside, California, United States, 92501
Sponsors and Collaborators
Arrowhead Regional Medical Center
Principal Investigator: Zeid Kayali, MD Southern California Transplantation Institute Research Foundation

Responsible Party: Zeid Kayali, MD, Associate Professor of Medicine, Arrowhead Regional Medical Center Identifier: NCT01465516     History of Changes
Other Study ID Numbers: 38950
First Posted: November 4, 2011    Key Record Dates
Last Update Posted: June 30, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Peginterferon alfa-2b
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents