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Neutrino Regimen for Treatment-experienced HCV GT1 Patients

Primary Purpose

Chronic Hepatitis C Infection

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
SOF+PEG+RBV
Sponsored by
Humanity and Health Research Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis C Infection

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Liver Fibrosis Diagnosis and Treatment Centre, 302 Hospital
  • Humanity and Health GI and Liver Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SOF+PEG+RBV

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in HCV RNA From Baseline to Week 12
Proportion of participants with on-treatment virologic breakthrough and relapse

Full Information

First Posted
June 21, 2015
Last Updated
August 18, 2016
Sponsor
Humanity and Health Research Centre
Collaborators
Beijing 302 Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02480686
Brief Title
Neutrino Regimen for Treatment-experienced HCV GT1 Patients
Official Title
Efficacy and Safety of Neutrino Therapy for Chronic HCV Genotype 1b Treatment-experienced Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Humanity and Health Research Centre
Collaborators
Beijing 302 Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SOF+PEG+RBV
Arm Type
Experimental
Arm Description
Participants with HCV genotype 1b infection will receive Sofosbuvir (SOF) 400 mg +PEG+RBV for 12 weeks.
Intervention Type
Drug
Intervention Name(s)
SOF+PEG+RBV
Other Intervention Name(s)
GS-7977, PSI-7977, Sovaldi®, Pegasys®, Copegus®
Intervention Description
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).
Primary Outcome Measure Information:
Title
Proportion of participants with sustained virologic response 12 weeks after discontinuation of therapy (SVR12)
Description
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
Title
Proportion of participants with adverse events leading to permanent discontinuation of study drug(s)
Description
Adverse events leading to permanent discontinuation of study drug(s)
Time Frame
Baseline up to Week 24
Secondary Outcome Measure Information:
Title
Change in HCV RNA From Baseline to Week 12
Time Frame
Baseline up to Week 24
Title
Proportion of participants with on-treatment virologic breakthrough and relapse
Time Frame
Baseline up to Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Lau, MD
Organizational Affiliation
Humanity and Health GI and Liver Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Guofeng Chen, MD
Organizational Affiliation
302 Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Liver Fibrosis Diagnosis and Treatment Centre, 302 Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100039
Country
China
Facility Name
Humanity and Health GI and Liver Centre
City
Hong Kong
State/Province
Hong Kong
ZIP/Postal Code
00852
Country
China

12. IPD Sharing Statement

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Neutrino Regimen for Treatment-experienced HCV GT1 Patients

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