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Neutrino Regimen for Treatment-experienced HCV GT1 Patients

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ClinicalTrials.gov Identifier: NCT02480686
Recruitment Status : Completed
First Posted : June 24, 2015
Last Update Posted : August 22, 2016
Sponsor:
Collaborator:
Beijing 302 Hospital
Information provided by (Responsible Party):
Humanity and Health Research Centre

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

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Infection Drug: SOF+PEG+RBV Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Neutrino Therapy for Chronic HCV Genotype 1b Treatment-experienced Patients
Study Start Date : January 2015
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Sofosbuvir

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:
  • GS-7977
  • PSI-7977
  • Sovaldi®
  • Pegasys®
  • Copegus®




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02480686


Locations
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China, Beijing
Liver Fibrosis Diagnosis and Treatment Centre, 302 Hospital
Beijing, Beijing, China, 100039
China, Hong Kong
Humanity and Health GI and Liver Centre
Hong Kong, Hong Kong, China, 00852
Sponsors and Collaborators
Humanity and Health Research Centre
Beijing 302 Hospital
Investigators
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Principal Investigator: George Lau, MD Humanity and Health GI and Liver Centre
Principal Investigator: Guofeng Chen, MD 302 Hospital
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Responsible Party: Humanity and Health Research Centre
ClinicalTrials.gov Identifier: NCT02480686    
Other Study ID Numbers: H&H_Neutrino Therapy
First Posted: June 24, 2015    Key Record Dates
Last Update Posted: August 22, 2016
Last Verified: August 2016
Additional relevant MeSH terms:
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Hepatitis C
Hepatitis C, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis, Chronic
Sofosbuvir
Antiviral Agents
Anti-Infective Agents