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Completed

NCT Number: NCT02576314

Sofosbuvir Containing Regimens for the Treatment of Chronic HCV GT3 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 genotype 3 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 3

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 3 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;
  • Negative pregnancy test at baseline (females of childbearing potential only);
  • Use of two effective contraception methods if female of childbearing potential or sexually active male.

Exclusion criteria

  • Pregnant or nursing female;
  • HIV infection or HBV infection (HBcAb and HBsAg positive);
  • 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

sofosbuvir and daclatasvir

Drug

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

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

Ledipasvir/Sofosbuvir

Drug

Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (FDC) tablet administered orally.

once daily;

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

Primary outcomes

  1. Proportion of participants with sustained virologic response 12 weeks (SVR12) after discontinuation of therapy

    Time frame: Post treatment Week 12

    SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ < 25 IU/mL) 12 weeks following the last dose of study medication

  2. Incidence of adverse events leading to permanent discontinuation of study drug

    Time frame: Baseline up to Week 12

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 12

  2. HCV RNA levels and change during and after treatment

    Time frame: Baseline up to Week 12

  3. Treatment adherence

    Time frame: Baseline to Week 12

    To evaluate the proportion of patients adherent to therapy (both on-treatment adherence and treatment discontinuation)

  4. Change in health related quality of life

    Time frame: Baseline to Week 24

    To evaluate the change in health-related quality of life during treatment

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 3 Infection

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Oct 15, 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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