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

NCT02759861 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 0121-16-FB
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Genotype 1 Hepatitis C Virus

Outcome Measures

Primary Outcomes (1)

• The Number of Subjects Who Achieve Negative RNA in Alcoholics

  Sustained viral response in treatment -naive heavy alcohol drinking patients.

  12 weeks after the end of Harvoni therapy

Secondary Outcomes (1)

• Number of Subjects With Advanced Fibrosis Score of F3/F4 Who Achieve SVR

  12 weeks after the end of Harvoni therapy

Study Arms (1)

Harvoni x 8 or 12 weeks

EXPERIMENTAL

patient will receive 8 or 12 weeks depending on clinical data

Drug: harvoni

Interventions

harvoni DRUG

8 or 12 weeks of harvoni therapy with monthly nursing visiting to monitor alcohol and adherence of harvoni therapy

Also known as: Ledipasvir/Sofosbuvir

Harvoni x 8 or 12 weeks

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska

Omaha, Nebraska, 680017, United States

Location

MeSH Terms

Interventions

ledipasvir, sofosbuvir drug combination

Results Point of Contact

• Title: Mark Mailliard
• Organization: University of Nebraska Medical Center

mark.mailliard@unmc.edu

402-559-8126

Study Officials

• Mark Mailliard, MD

  UNMC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2016
• First Posted: May 3, 2016
• Study Start: August 1, 2016
• Primary Completion: August 1, 2020
• Study Completion: October 1, 2020
• Last Updated: December 29, 2023
• Results First Posted: February 23, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)