NCT02480686

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 24, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

August 22, 2016

Status Verified

August 1, 2016

Enrollment Period

1.6 years

First QC Date

June 21, 2015

Last Update Submit

August 18, 2016

Conditions

Chronic Hepatitis C Infection

Outcome Measures

Primary Outcomes (2)

  • 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.

    Post treatment Week 12

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

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

    Baseline up to Week 24

Secondary Outcomes (2)

  • Change in HCV RNA From Baseline to Week 12

    Baseline up to Week 24

  • Proportion of participants with on-treatment virologic breakthrough and relapse

    Baseline up to Week 24

Study Arms (1)

SOF+PEG+RBV

EXPERIMENTAL

Participants with HCV genotype 1b infection will receive Sofosbuvir (SOF) 400 mg +PEG+RBV for 12 weeks.

Drug: SOF+PEG+RBV

Interventions

SOF+PEG+RBVDRUG

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®
SOF+PEG+RBV

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Liver Fibrosis Diagnosis and Treatment Centre, 302 Hospital

Beijing, Beijing Municipality, 100039, China

Location

Humanity and Health GI and Liver Centre

Hong Kong, Hong Kong, 00852, China

Location

MeSH Terms

Interventions

Sofosbuvirpeginterferon alfa-2aRibavirin

Intervention Hierarchy (Ancestors)

Uridine MonophosphateUracil NucleotidesPyrimidine NucleotidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsNucleotidesNucleic Acids, Nucleotides, and NucleosidesRibonucleotidesRibonucleosidesNucleosides

Study Officials

  • George Lau, MD

    Humanity and Health GI and Liver Centre

    PRINCIPAL INVESTIGATOR

  • Guofeng Chen, MD

    302 Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2015

First Posted

June 24, 2015

Study Start

January 1, 2015

Primary Completion

August 1, 2016

Study Completion

August 1, 2016

Last Updated

August 22, 2016

Record last verified: 2016-08

Locations

CN(2)