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Determine the Efficacy and Safety of Harvoni in Genotype 1 Chronic Hepatitis c Infected People Who Are Alcoholics

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: NCT02759861
Recruitment Status : Active, not recruiting
First Posted : May 3, 2016
Last Update Posted : December 11, 2019
Information provided by (Responsible Party):
University of Nebraska

Brief Summary:
To determine the efficacy and safety of Harvoni in treatment-naïve alcoholic subjects with Genotype 1 HCV infection

Condition or disease Intervention/treatment Phase
Genotype 1 Hepatitis C Virus Drug: harvoni Phase 4

Detailed Description:
determine the cure rate of Harvoni in treatment naïve alcoholic subjects with Genotype 1 HCV infection

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : August 2016
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Harvoni x 8 or 12 weeks
patient will receive 8 or 12 weeks depending on clinical data
Drug: harvoni
8 or 12 weeks of harvoni therapy with monthly nursing visiting to monitor alcohol and adherence of harvoni therapy
Other Name: Ledipasvir/Sofosbuvir

Primary Outcome Measures :
  1. The number of subjects who achieve negative RNA in alcoholics [ Time Frame: 12 weeks after the end of Harvoni therapy ]
    determined by blood draw

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.

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. The subject must be willingly and able to provide written informed consent
  2. Age 19 years of age or older (The age of consent in Nebraska)
  3. 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
  4. HCV RNA level at most 6 months prior to the Baseline/Day 1 visit.
  5. HCV genotyping 1a, 1b, or mixed 1a/ab. Any non-definitive results will exclude the subject from study participation.
  6. Alcohol misuse as defined by the Alcohol Use Disorders Identification Test (AUDIT) score subjects must score > 8 (associated with harmful or hazardous drinking)
  7. Cirrhosis determination [up to 20% of study subjects may have cirrhosis]:

    1. 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
    2. 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
  8. Liver imaging within 6 months of Baseline/Day 1 to exclude hepatocellular carcinoma HCC) is required
  9. Subjects must have the following laboratory parameters at screening:

    1. ALT < 10 x the upper limit of normal (ULN)
    2. AST < 10 x ULN
    3. Direct bilirubin < 2.0 x ULN
    4. Platelets > 50,000
    5. HbA1c < 8.5%
    6. Creatinine clearance (CLcr) ≥ 60 mL /min, as calculated by the Cockcroft-Gault equation
    7. Hemoglobin ≥ 11 g/dL for female subjects; ≥ 12 g/dL for male subjects.
    8. Albumin ≥ 2.5 g/dL
    9. INR ≤ 1.5 x ULN unless subject has known hemophilia or is stable on an anticoagulant regimen affecting INR.
  10. Subject has not been treated with any investigational drug or device within 30 days of the screening visit.

Exclusion Criteria:

  1. 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.
  2. Serious concurrent medical illness which would jeopardize the ability of the subject to receive the therapy as outlined in this protocol with reasonable safety.
  3. 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.
  4. Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
  5. Use of any prohibited concomitant medications within 30 days of the Baseline/Day 1 visit.
  6. Known hypersensitivity to LDV/SOF

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): NCT02759861

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United States, Nebraska
University of Nebraska
Omaha, Nebraska, United States, 680017
Sponsors and Collaborators
University of Nebraska
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Principal Investigator: Mark Mailliard, MD UNMC

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Responsible Party: University of Nebraska Identifier: NCT02759861    
Other Study ID Numbers: 121-16
First Posted: May 3, 2016    Key Record Dates
Last Update Posted: December 11, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: with Gilead Inc.
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ledipasvir, sofosbuvir drug combination
Antiviral Agents
Anti-Infective Agents