Neutrino Regimen for Treatment-experienced HCV GT1 Patients

Chronic Hepatitis C Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02480686
• Other study ID #: H&H_Neutrino Therapy
• Status: Completed
• Phase: Phase 4
• First received: June 21, 2015
• Last updated: August 18, 2016
• Start date: January 2015
• Est. completion date: August 2016

Study information

• Verified date: August 2016
• Source: Humanity & Healthy GI and Liver Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Department of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Hepatitis C Infection
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic

Intervention

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).

Locations

Country	Name	City	State
China	Liver Fibrosis Diagnosis and Treatment Centre, 302 Hospital	Beijing	Beijing
China	Humanity and Health GI and Liver Centre	Hong Kong	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
Humanity & Healthy GI and Liver Centre	Beijing 302 Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	Yes
Secondary	Change in HCV RNA From Baseline to Week 12		Baseline up to Week 24	No
Secondary	Proportion of participants with on-treatment virologic breakthrough and relapse		Baseline up to Week 24	No