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Completed

NCT Number: NCT01987453

Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin in Participants With Chronic Genotype 1 HCV Who Participated in a Prior Gilead-Sponsored HCV Treatment Study

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) with or without ribavirin (RBV) in participants with chronic genotype 1 hepatitis C virus (HCV) infection who have participated in a prior Gilead-sponsored HCV treatment study, and who did not achieve sustained virologic response (SVR24), defined as HCV RNA < lower limit of quantification (LLOQ) 24 weeks after last dose of study drug (SVR24).

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Key information

Conditions

HCV Infection 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 2

Primary location

Camperdown, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Key Inclusion Criteria:

  • Willing and able to provide written informed consent
  • Infection with HCV genotype 1
  • HCV RNA > LLOQ at screening
  • Participation in a prior Gilead-sponsored study
  • Screening laboratory values within defined thresholds
  • Use of two effective contraception methods if female of childbearing potential or sexually active male
  • Must be of generally good health, with the exception of chronic HCV infection, as determined by the Investigator
  • Must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments

Key Exclusion Criteria:

  • Pregnant or nursing female or male with pregnant female partner
  • Co-infection with HIV or hepatitis B virus (HBV)
  • Current or prior history of clinical hepatic decompensation (Groups 1 and 2 only)
  • Hepatocellular carcinoma (HCC)
  • History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Treatment and study plan

LDV/SOF

Drug

Tablet(s) administered orally once daily

Other names: Harvoni®, GS-5885/GS-7977

RBV

Drug

Tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

Participants in the LDV/SOF+RBV 24 weeks group will dose adjust RBV according to hemoglobin and renal status as stated in the RBV package insert.

Primary outcomes

  1. Percentage of Participants With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)

    Time frame: Post-treatment Week 12

    SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study treatment.

  2. Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

    Time frame: Up to 24 Weeks

Secondary outcomes

  1. Percentage of Participants With Sustained Virologic Response (SVR) at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)

    Time frame: Posttreatment Weeks 4 and 24

    SVR4 and SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study treatment, respectively.

  2. Percentage of Participants With HCV RNA < LLOQ While on Treatment

    Time frame: Baseline to Week 24

  3. Change in HCV RNA From Baseline

    Time frame: Baseline to Week 8

  4. Percentage of Participants With Virologic Failure

    Time frame: Up to posttreatment Week 24

    Virologic failure was defined as:

    • On-treatment virologic failure:
    • Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
    • Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
    • Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)
    • Virologic relapse:
    • Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit confirmed with 2 consecutive values or last available posttreatment measurement

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study title

An Open-Label, Multicenter Study To Evaluate The Efficacy And Safety Of Sofosbuvir/Ledipasvir Fixed-Dose Combination ± Ribavirin For 12 or 24 Weeks In Chronic Genotype 1 HCV Infected Subjects Who Participated In A Prior Gilead-Sponsored HCV Treatment Study

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 19, 2013
Registry last updated
Nov 19, 2018

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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