Switching Regimen in Treating Cirrhotic HCV GT1b Subjects

Chronic Hepatitis C Infection Clinical Trial

— SWITCH-1  

Official title:

Efficacy and Safety of Switching From Pegylated Interferon/Ribavirin (PR) to Direct-acting Antiviral Agents (DAAs) for Chinese With CHC Genotype 1b Infection (SWITCH-1)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02583685
• Other study ID #: H&H_SWITCH-1
• Status: Recruiting
• Phase: Phase 2
• Start date: May 2015
• Est. completion date: December 2022

Study information

• Verified date: August 2021
• Source: Humanity and Health Research Centre
• Contact: Chen WANG, MD, PhD
• Phone: +85228613777
• Email: doc_chengwang[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a prospective, randomized study to evaluate the efficacy and safety of switching treatment from Peg-interferon and Ribavirin to direct-acting antiviral agents in Chinese with CHC genotype 1b infection, who are interferon/ribavirin-intolerant.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: December 2022
• Est. primary completion date: October 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Individuals with chronic HCV GT1b infection;
• HCV RNA = 10000 IU/mL at screening;
• Received 4 weeks pegylated interferon plus ribavirin (PR4) therapy and are intolerant to PR4;
• Cirrhosis determination; a liver biopsy may be required;
• Use of highly effective contraception methods if female of childbearing potential or sexually active male;

Exclusion Criteria:

• Pregnant or nursing female or male with pregnant female partner;
• HIV or HBV co-infection;
• Hematologic or biochemical parameters at Screening outside the protocol- specified requirements;
• Active or recent history (= 1 year) of drug or alcohol abuse;
• 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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• PR4 + LDV/SOF + ASV 4 wk
Pegylated interferon alfa-2a (PEG) 180 µg administered once weekly by subcutaneous injection; Ribavirin (RBV) administered as a tablet orally according to body weight (< 75kg = 1000 mg and = 75 kg = 1200 mg); Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (FDC) tablet administered orally once daily; Asunaprevir (ASV) 200mg administered orally twice daily.
• PR4 + LDV/SOF + SMV 4 wk
Pegylated interferon alfa-2a (PEG) 180 µg administered once weekly by subcutaneous injection; Ribavirin (RBV) administered as a tablet orally according to body weight (< 75kg = 1000 mg and = 75 kg = 1200 mg); Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (FDC) tablet administered orally once daily; Simeprevir (SMV) 150 mg tablet orally once daily.
• PR4 + LDV/SOF + ASV 6 wk
Pegylated interferon alfa-2a (PEG) 180 µg administered once weekly by subcutaneous injection; Ribavirin (RBV) administered as a tablet orally according to body weight (< 75kg = 1000 mg and = 75 kg = 1200 mg); Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (FDC) tablet administered orally once daily; Asunaprevir (ASV) 200mg administered orally twice daily.
• PR4 + LDV/SOF + SMV 6 wk
Pegylated interferon alfa-2a (PEG) 180 µg administered once weekly by subcutaneous injection; Ribavirin (RBV) administered as a tablet orally according to body weight (< 75kg = 1000 mg and = 75 kg = 1200 mg); Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (FDC) tablet administered orally once daily; Simeprevir (SMV) 150 mg tablet orally once daily.
• PR4 + LDV/SOF + ASV 8 wk
Pegylated interferon alfa-2a (PEG) 180 µg administered once weekly by subcutaneous injection; Ribavirin (RBV) administered as a tablet orally according to body weight (< 75kg = 1000 mg and = 75 kg = 1200 mg); Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (FDC) tablet administered orally once daily; Asunaprevir (ASV) 200mg administered orally twice daily.
• PR4 + LDV/SOF + SMV 8 wk
Pegylated interferon alfa-2a (PEG) 180 µg administered once weekly by subcutaneous injection; Ribavirin (RBV) administered as a tablet orally according to body weight (< 75kg = 1000 mg and = 75 kg = 1200 mg); Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (FDC) tablet administered orally once daily; Simeprevir (SMV) 150 mg tablet orally once daily.
• PR4 + LDV/SOF + ASV 12 wk
Pegylated interferon alfa-2a (PEG) 180 µg administered once weekly by subcutaneous injection; Ribavirin (RBV) administered as a tablet orally according to body weight (< 75kg = 1000 mg and = 75 kg = 1200 mg); Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (FDC) tablet administered orally once daily; Asunaprevir (ASV) 200mg administered orally twice daily.
• PR4 + LDV/SOF + SMV 12 wk
Pegylated interferon alfa-2a (PEG) 180 µg administered once weekly by subcutaneous injection; Ribavirin (RBV) administered as a tablet orally according to body weight (< 75kg = 1000 mg and = 75 kg = 1200 mg); Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (FDC) tablet administered orally once daily; Simeprevir (SMV) 150 mg tablet orally once daily.

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 (3)

Lead Sponsor	Collaborator
Humanity and Health Research Centre	Beijing 302 Hospital, Nanfang Hospital of Southern Medical University

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 (SVR12) after discontinuation of therapy	SVR12 is defined as HCV RNA < lower limit of quantification (LLOQ) 12 weeks after last dose of study drug.	Post treatment Week 12
Primary	Proportion of participants with adverse events leading to permanent discontinuation of study drug(s)		Baseline up to Week 24
Secondary	Proportion of participants with unquantifiable HCV viral load at specified time points during and after treatment		Baseline up to Week 24
Secondary	Treatment adherence	To evaluate the proportion of patients adherent to therapy (both on-treatment adherence and treatment discontinuation)	Baseline to Week 12
Secondary	Change in health related quality of life evaluated with questionnaires	To evaluate the change in health-related quality of life during and after treatment with questionnaires	Up to Posttreatment Week 24
Secondary	Change in mental health evaluated with questionnaires	To evaluate the change in mental health during and after treatment with questionnaires	Up to Posttreatment Week 24
Secondary	Liver disease progression	Liver disease progression is a composite endpoint measured by laboratory parameters (alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, albumin, platelets, prothrombin time (PT) and a-fetoprotein) and observed or reported clinical signs and symptoms.	Up to 10 years