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CompletedNCT02480686Updated Aug 22, 2016

Neutrino Regimen for Treatment-experienced HCV GT1 Patients

A Phase 4 interventional study of SOF+PEG+RBV in Chronic Hepatitis C Infection, sponsored by Humanity and Health Research Centre. Completed at 2 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-08-22.

Sponsored by Humanity and Health Research Centre · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
32
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Chronic Hepatitis C Infection
03

In context

Hepatitis C

2,321 studies on the registry are indexed under Hepatitis C; 102 are open to participants now.

This study's enrollment of 32 is below the median of 79 across 1,633 interventional studies indexed under Hepatitis C.

Browse Hepatitis C studies →

Lead sponsor

Humanity and Health Research Centre is the lead sponsor of 14 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
32 participants (actual)

Study arms

  • 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

Interventions

  • DrugSOF+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).

    Also known as: GS-7977, PSI-7977, Sovaldi®, Pegasys®, Copegus®

06

What researchers measure

Primary outcomes

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

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

    Time frame: Post treatment Week 12

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

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

    Time frame: Baseline up to Week 24

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

07

Study locations

2 sites
  • Liver Fibrosis Diagnosis and Treatment Centre, 302 Hospital
    Beijing, Beijing 100039, China
  • Humanity and Health GI and Liver Centre
    Hong Kong, Hong Kong 00852, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 22, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02480686
Lead sponsor
Humanity and Health Research Centre
Collaborators
Beijing 302 Hospital
Responsible party
Sponsor
First posted
Jun 24, 2015
Start date
Jan 2015
Primary completion
Aug 2016
Completion
Aug 2016
Last update
Aug 22, 2016

Study contacts

George Lau, MD
principal investigator · Humanity and Health GI and Liver Centre
Guofeng Chen, MD
principal investigator · 302 Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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