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Completed

NCT Number: NCT02480166

Comparative Efficacy of Fixed-dose Combination Sofosbuvir + Ledipasvir, 8 vs. 12 Weeks in 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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Stanford University Medical Center, Palo Alto, California, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

8 weeks SOF/LED

Drug

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

12 weeks SOF/LED

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • Gilead Sciences

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 24, 2015
Registry last updated
Sep 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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