Comparative Efficacy of Fixed-dose Combination Sofosbuvir + Ledipasvir, 8 vs. 12 Weeks in Chronic Hepatitis C Genotype 6

August 21, 2017 updated by: Mindie H. Nguyen, Stanford University

Comparative Efficacy of Fixed-dose Combination of Sofosbuvir and Ledipasvir for 8 or 12 Weeks for Chronic Hepatitis C Genotype 6

The primary objectives of this study are to describe the efficacy of:

  1. 8-week treatment of SOF/LED for treatment-naïve, non-cirrhotic, HCV genotype 6
  2. 12-week treatment of SOF/LED for all other HCV-6 populations

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The secondary objective of this study is to describe safety, persistency, and tolerability of SOF/LED in patients with HCV-6.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Stanford University Medical Center
      • San Jose, California, United States, 95128
        • San Jose Gastroenterology
    • Texas
      • Houston, Texas, United States, 77072
        • Liver and Digestive Consultants
      • Plano, Texas, United States, 75093
        • Digestive Health Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or female, age ≥18 years
  2. HCV genotype 6 or indeterminate and later assessed at Screening and confirmed as genotype 6
  3. Selected to start on treatment by their treating providers
  4. Willing and able to provide informed consent
  5. Able to comply with dosing instructions for study drug administration and able to complete the study schedule of assessments
  6. Females of childbearing potential must have a negative serum pregnancy test at Screening and a negative pregnancy test on Baseline
  7. Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
  8. Lactating females must agree to discontinue nursing before the study drug is administered

Exclusion Criteria:

  1. Previous recipient of a liver transplant
  2. Co-infection with human immunodeficiency virus (HIV) or hepatitis B (HBV)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 8 weeks SOF/LED
Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment with fixed-dose combination sofosbuvir (400 mg) and ledipasvir (90 mg) daily.
Drug: 8 weeks SOF/LED
Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment. The drug will be administered orally, per manufacturers' instructions, and can be taken with or without food.
Other Names:
  • Harvoni
  • Solvaldi
Experimental: 12 weeks SOF/LED
Patients that are either treatment experienced or are cirrhotic will be assigned to 12 weeks of treatment with fixed-dose combination sofosbuvir (400 mg) and ledipasvir (90 mg) daily.
Drug: 12 weeks SOF/LED
Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are not treatment naïve or have cirrhosis will be assigned to 12 weeks of treatment. The drug will be administered orally, per manufacturers' instructions, and can be taken with or without food.
Other Names:
  • Harvoni
  • Solvaldi

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With a Sustained Virologic Response (SVR) log10 HCV RNA PCR <25 IU/mL 12 Weeks Post-treatment
Time Frame: 12 weeks after end of therapy
12 weeks after end of therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Experienced Serious Adverse Events (SAEs) and/or Adverse Events (AEs) From Informed Consent to 12 Weeks Post-treatment.
Time Frame: Day 1 of treatment to 12 weeks post treatment
Adverse events were defined using Common Terminology Criteria for Adverse Events v3.0 (CTCAE)
Day 1 of treatment to 12 weeks post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

Gilead Sciences

Investigators

  • Principal Investigator: Mindie H Nguyen, MD, MAS, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

October 1, 2016

Study Completion (Actual)

October 1, 2016

Study Registration Dates

First Submitted

June 17, 2015

First Submitted That Met QC Criteria

June 19, 2015

First Posted (Estimate)

June 24, 2015

Study Record Updates

Last Update Posted (Actual)

September 19, 2017

Last Update Submitted That Met QC Criteria

August 21, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 33196

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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