Determine the Efficacy and Safety of Harvoni in Genotype 1 Chronic Hepatitis c Infected People Who Are Alcoholics
Primary Purpose
Genotype 1 Hepatitis C Virus
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
harvoni
Sponsored by
About this trial
This is an interventional treatment trial for Genotype 1 Hepatitis C Virus
Eligibility Criteria
Inclusion Criteria:
- The subject must be willingly and able to provide written informed consent
- Age 19 years of age or older (The age of consent in Nebraska)
- HCV treatment-naïve, as defined as no prior exposure to any Interferon (IFN), RBV, or other FDA approved or experimental HCV-specific direct-acting antiviral agent
- HCV RNA level at most 6 months prior to the Baseline/Day 1 visit.
- HCV genotyping 1a, 1b, or mixed 1a/ab. Any non-definitive results will exclude the subject from study participation.
- Alcohol misuse as defined by the Alcohol Use Disorders Identification Test (AUDIT) score subjects must score > 8 (associated with harmful or hazardous drinking)
Cirrhosis determination [up to 20% of study subjects may have cirrhosis]:
Cirrhosis is defined as any one of the following:
- History of a liver biopsy showing cirrhosis (e.g. Metavir score = 4 or Ishak score > 5)
- Fibroscan showing cirrhosis or results > 12.5 kPa
- FIBRO Spect II index consistent with F3 or F4 AND an AST : platelet ration index (APRI) of > 2 during Screening
Absence of cirrhosis is defined as any one of the following:
- Liver biopsy within 2 years of Screening showing absence of cirrhosis
- Fibroscan within 6 months of Baseline/Day1 with a result of ≤ 12.5 kPa
- FIBRO Spect II Index consistent with F0- F2 AND APRI of ≤ 1 during Screening
- Liver imaging within 6 months of Baseline/Day 1 to exclude hepatocellular carcinoma HCC) is required
Subjects must have the following laboratory parameters at screening:
- ALT < 10 x the upper limit of normal (ULN)
- AST < 10 x ULN
- Direct bilirubin < 2.0 x ULN
- Platelets > 50,000
- HbA1c < 8.5%
- Creatinine clearance (CLcr) ≥ 60 mL /min, as calculated by the Cockcroft-Gault equation
- Hemoglobin ≥ 11 g/dL for female subjects; ≥ 12 g/dL for male subjects.
- Albumin ≥ 2.5 g/dL
- INR ≤ 1.5 x ULN unless subject has known hemophilia or is stable on an anticoagulant regimen affecting INR.
- Subject has not been treated with any investigational drug or device within 30 days of the screening visit.
Exclusion Criteria:
- Pregnant women and nursing mothers are ineligible due to the possible risk of adverse effects in the newborn. Eligible patients of reproductive potential should use adequate contraception if sexually active.
- Serious concurrent medical illness which would jeopardize the ability of the subject to receive the therapy as outlined in this protocol with reasonable safety.
- Malignancy diagnosed or treated within 5 years (recent localized treatment of squamous or non-invasive basal cell skin cancers is permitted; cervical carcinoma in situ is allowed if appropriately treated prior to screening); subjects under evaluation for a malignancy are not eligible.
- Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
- Use of any prohibited concomitant medications within 30 days of the Baseline/Day 1 visit.
- Known hypersensitivity to LDV/SOF
Sites / Locations
- University of Nebraska
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Harvoni x 8 or 12 weeks
Arm Description
patient will receive 8 or 12 weeks depending on clinical data
Outcomes
Primary Outcome Measures
The Number of Subjects Who Achieve Negative RNA in Alcoholics
Sustained viral response in treatment -naive heavy alcohol drinking patients.
Secondary Outcome Measures
Number of Subjects With Advanced Fibrosis Score of F3/F4 Who Achieve SVR
Number of alcoholics with HCV type 1 genotype who had advanced fibrosis F3/F4 who achieve SVR
Full Information
NCT ID
NCT02759861
First Posted
April 26, 2016
Last Updated
September 27, 2023
Sponsor
University of Nebraska
1. Study Identification
Unique Protocol Identification Number
NCT02759861
Brief Title
Determine the Efficacy and Safety of Harvoni in Genotype 1 Chronic Hepatitis c Infected People Who Are Alcoholics
Official Title
A Phase IV, Single Arm, Open-Label Study to Determine the Efficacy and Safety of Ledipasvir/Sofosbuvir (LDV/SOF) in Treatment-Naive Alcoholic Subjects With Chronic Genotype 1 Hepatitis C Infection
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
August 1, 2016 (Actual)
Primary Completion Date
August 1, 2020 (Actual)
Study Completion Date
October 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Nebraska
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To determine the efficacy and safety of Harvoni in treatment-naïve alcoholic subjects with Genotype 1 HCV infection
Detailed Description
determine the cure rate of Harvoni in treatment naïve alcoholic subjects with Genotype 1 HCV infection
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Genotype 1 Hepatitis C Virus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Harvoni x 8 or 12 weeks
Arm Type
Experimental
Arm Description
patient will receive 8 or 12 weeks depending on clinical data
Intervention Type
Drug
Intervention Name(s)
harvoni
Other Intervention Name(s)
Ledipasvir/Sofosbuvir
Intervention Description
8 or 12 weeks of harvoni therapy with monthly nursing visiting to monitor alcohol and adherence of harvoni therapy
Primary Outcome Measure Information:
Title
The Number of Subjects Who Achieve Negative RNA in Alcoholics
Description
Sustained viral response in treatment -naive heavy alcohol drinking patients.
Time Frame
12 weeks after the end of Harvoni therapy
Secondary Outcome Measure Information:
Title
Number of Subjects With Advanced Fibrosis Score of F3/F4 Who Achieve SVR
Description
Number of alcoholics with HCV type 1 genotype who had advanced fibrosis F3/F4 who achieve SVR
Time Frame
12 weeks after the end of Harvoni therapy
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The subject must be willingly and able to provide written informed consent
Age 19 years of age or older (The age of consent in Nebraska)
HCV treatment-naïve, as defined as no prior exposure to any Interferon (IFN), RBV, or other FDA approved or experimental HCV-specific direct-acting antiviral agent
HCV RNA level at most 6 months prior to the Baseline/Day 1 visit.
HCV genotyping 1a, 1b, or mixed 1a/ab. Any non-definitive results will exclude the subject from study participation.
Alcohol misuse as defined by the Alcohol Use Disorders Identification Test (AUDIT) score subjects must score > 8 (associated with harmful or hazardous drinking)
Cirrhosis determination [up to 20% of study subjects may have cirrhosis]:
Cirrhosis is defined as any one of the following:
History of a liver biopsy showing cirrhosis (e.g. Metavir score = 4 or Ishak score > 5)
Fibroscan showing cirrhosis or results > 12.5 kPa
FIBRO Spect II index consistent with F3 or F4 AND an AST : platelet ration index (APRI) of > 2 during Screening
Absence of cirrhosis is defined as any one of the following:
Liver biopsy within 2 years of Screening showing absence of cirrhosis
Fibroscan within 6 months of Baseline/Day1 with a result of ≤ 12.5 kPa
FIBRO Spect II Index consistent with F0- F2 AND APRI of ≤ 1 during Screening
Liver imaging within 6 months of Baseline/Day 1 to exclude hepatocellular carcinoma HCC) is required
Subjects must have the following laboratory parameters at screening:
ALT < 10 x the upper limit of normal (ULN)
AST < 10 x ULN
Direct bilirubin < 2.0 x ULN
Platelets > 50,000
HbA1c < 8.5%
Creatinine clearance (CLcr) ≥ 60 mL /min, as calculated by the Cockcroft-Gault equation
Hemoglobin ≥ 11 g/dL for female subjects; ≥ 12 g/dL for male subjects.
Albumin ≥ 2.5 g/dL
INR ≤ 1.5 x ULN unless subject has known hemophilia or is stable on an anticoagulant regimen affecting INR.
Subject has not been treated with any investigational drug or device within 30 days of the screening visit.
Exclusion Criteria:
Pregnant women and nursing mothers are ineligible due to the possible risk of adverse effects in the newborn. Eligible patients of reproductive potential should use adequate contraception if sexually active.
Serious concurrent medical illness which would jeopardize the ability of the subject to receive the therapy as outlined in this protocol with reasonable safety.
Malignancy diagnosed or treated within 5 years (recent localized treatment of squamous or non-invasive basal cell skin cancers is permitted; cervical carcinoma in situ is allowed if appropriately treated prior to screening); subjects under evaluation for a malignancy are not eligible.
Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
Use of any prohibited concomitant medications within 30 days of the Baseline/Day 1 visit.
Known hypersensitivity to LDV/SOF
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Mailliard, MD
Organizational Affiliation
UNMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Nebraska
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
680017
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Determine the Efficacy and Safety of Harvoni in Genotype 1 Chronic Hepatitis c Infected People Who Are Alcoholics
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