Neutrino Regimen for Treatment-experienced HCV GT1 Patients

August 18, 2016 updated by: Humanity and Health Research Centre

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

32

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100039
        • Liver Fibrosis Diagnosis and Treatment Centre, 302 Hospital
    • Hong Kong
      • Hong Kong, Hong Kong, China, 00852
        • Humanity and Health GI and Liver Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age equal to or greater than 18 years, with chronic genotype 1b infection;
  2. HCV RNA equal to or greater than 10,000 IU/mL at Screening;
  3. Cirrhosis determination;
  4. Subjects who are treatment-experienced;
  5. Screening laboratory values within defined thresholds;
  6. Use of highly effective contraception methods if female of childbearing potential or sexually active male.

Exclusion Criteria:

  1. HIV or chronic hepatitis B virus (HBV) infection;
  2. Contraindications for PEG or RBV therapy;
  3. Hematologic or biochemical parameters at Screening outside the protocol-specified requirements;
  4. Active or recent history (≤ 1 year) of drug or alcohol abuse;
  5. Hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers);
  6. Chronic use of systemic immunosuppressive agents;
  7. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SOF+PEG+RBV
Participants with HCV genotype 1b infection will receive Sofosbuvir (SOF) 400 mg +PEG+RBV for 12 weeks.
Drug: SOF+PEG+RBV
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:
  • Pegasys®
  • Copegus®
  • Sovaldi®
  • GS-7977
  • PSI-7977

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Post treatment Week 12
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)
Baseline up to Week 24

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in HCV RNA From Baseline to Week 12
Time Frame: Baseline up to Week 24
Baseline up to Week 24
Proportion of participants with on-treatment virologic breakthrough and relapse
Time Frame: Baseline up to Week 24
Baseline up to Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Humanity and Health Research Centre

Collaborators

Beijing 302 Hospital

Investigators

  • Principal Investigator: George Lau, MD, Humanity and Health GI and Liver Centre
  • Principal Investigator: Guofeng Chen, MD, 302 Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

June 21, 2015

First Submitted That Met QC Criteria

June 22, 2015

First Posted (Estimate)

June 24, 2015

Study Record Updates

Last Update Posted (Estimate)

August 22, 2016

Last Update Submitted That Met QC Criteria

August 18, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H&H_Neutrino Therapy

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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