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Completed

NCT Number: NCT02480686

Neutrino Regimen for Treatment-experienced HCV GT1 Patients

This study will evaluate the efficacy and safety of NEUTRINO regimen in Chinese chronic HCV genotype 1b treatment-experienced patients.

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Key information

Conditions

Chronic Hepatitis C Infection

Age range

18 year–80 year

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 1b infection;
  • HCV RNA equal to or greater than 10,000 IU/mL at Screening;
  • Cirrhosis determination;
  • Subjects who are treatment-experienced;
  • Screening laboratory values within defined thresholds;
  • Use of highly effective contraception methods if female of childbearing potential or sexually active male.

Exclusion criteria

  • HIV or chronic hepatitis B virus (HBV) infection;
  • Contraindications for PEG or RBV therapy;
  • 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);
  • Chronic use of systemic immunosuppressive agents;
  • History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the subject's participation for the full duration of the study, such that it is not in the best interest of the subject to participate.

Treatment and study plan

SOF+PEG+RBV

Drug

Sofosbuvir (SOF) 400 mg tablet is administered orally once daily; Pegylated interferon alfa-2a (PEG) 180 μg was administered once weekly by subcutaneous injection; Ribavirin (RBV) was administered as a tablet orally according to body weight (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg).

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

Primary outcomes

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

    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

    Adverse events leading to permanent discontinuation of study drug(s)

Secondary outcomes

  1. Change in HCV RNA From Baseline to Week 12

    Time frame: Baseline up to Week 24

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

    Time frame: Baseline up to Week 24

Sponsors and collaborators

Lead sponsor

Humanity and Health Research Centre

Other

Collaborators

  • Beijing 302 Hospital

Registry information

Official study title

Efficacy and Safety of Neutrino Therapy for Chronic HCV Genotype 1b Treatment-experienced Patients

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jun 24, 2015
Registry last updated
Aug 22, 2016

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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