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Completed

NCT Number: NCT02482077

Sofosbuvir Containing Regimens for the Treatment of Chronic HCV GT2 Infected Patients

The purpose of this study is to assess the safety, tolerability, and efficacy of Sofosbuvir containing regimens in treatment-naive or treatment-experienced patients with HCV genotypes 2 infection.

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Key information

Conditions

Chronic Hepatitis C Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Liver Fibrosis Diagnosis and Treatment Centre, 302 Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age equal to or greater than 18 years, with chronic genotype 2 HCV infection;
  • Documented HCV treatment-naïve or treatment-experienced subjects who failed previous PEG+RBV regimen;
  • HCV RNA > 10,000 IU/mL at Screening;
  • Screening laboratory values within defined thresholds
  • Use of two effective contraception methods if female of childbearing potential or sexually active male

Exclusion criteria

  • Pregnant or nursing female or male with pregnant female partner;
  • HIV or chronic hepatitis B virus (HBV) infection;
  • Hematologic or biochemical parameters at Screening outside the protocol-specified requirements;
  • Active or recent history (≤ 1 year) of drug or alcohol abuse;
  • Hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers).

Treatment and study plan

SOF+RBV

Drug

Sofosbuvir (SOF) 400 mg tablet administered orally once daily. Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg).

Other names: GS-7977, PSI-7977, Sovaldi®, Copegus®

SOF+DCV

Drug

Sofosbuvir (SOF) 400 mg tablet administered orally once daily. Daclatasvir (DCV) 60mg tablet administered once daily.

Other names: GS-7977, PSI-7977, Sovaldi®, BMS-790052, Daklinza®

LDV/SOF

Drug

Ledipasvir 90 mg /Sofosbuvir 400 mg (LDV/SOF) FDC tablet administered orally once daily

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

Primary outcomes

  1. Proportion of participants with sustained virologic response 12 weeks after discontinuation of therapy

    Time frame: Post treatment Week 12

    SVR12 is defined as HCV RNA < lower limit of quantification (LLOQ) 12 weeks after last dose of study drug.

  2. Proportion of participants with adverse events leading to permanent discontinuation of study drug(s)

    Time frame: Baseline up to Week 24

Secondary outcomes

  1. Proportion of participants with unquantifiable HCV viral load at specified time points during and after treatment

    Time frame: Baseline up to Week 24

  2. HCV RNA levels and change during and after treatment.

    Time frame: Baseline up to Week 24

  3. Proportion of participants with on-treatment virologic breakthrough and relapse

    Time frame: Baseline up to Week 24

    Viral breakthrough is defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) during treatment, but did not achieve a sustained virologic response (SVR). Viral relapse is defined as having achieved undetectable HCV RNA levels (HCV RNA < LLOQ) within 4 weeks of end of treatment, but did not achieve an SVR.

Sponsors and collaborators

Lead sponsor

Humanity and Health Research Centre

Other

Collaborators

  • Beijing 302 Hospital

Registry information

Official study title

Efficacy and Safety Study of Sofosbuvir Containing Regimens in Subjects With Chronic Hepatitis C Virus Genotype 2 Infection

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Jun 25, 2015
Registry last updated
Mar 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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