Treating Hispanic Patients Diagnosed With Hepatitis C Using Boceprevir

NCT01465516 | Terminated

• 1 other identifier: 38950
• Study Type: observational
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis C Infection

Outcome Measures

Primary Outcomes (1)

• SVR based on intention to treat analysis

  Patients who have detectable HCV RNA at week 24 must have study treatment discontinued.

  24 weeks

Secondary Outcomes (2)

• Tolerance

  48 weeks

• BDI II score 31 or above

  48 weeks

Study Arms (1)

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

Interventions

Boceprevir 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

Also known as: Victrelis

Hispanic, HCV genotype 1

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Arrowhead Regional Medical Center: lead

Study Sites (1)

Southern California Transplantation Institute Research Foundation

Riverside, California, 92501, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Hepatitis C

Interventions

N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamide

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Zeid Kayali, MD

  Southern California Transplantation Institute Research Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: November 2, 2011
• First Posted: November 4, 2011
• Study Start: November 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: June 30, 2015

Record last verified: 2015-06

Locations

US (1)