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Switching Regimen in Treating Cirrhotic HCV GT1b Subjects (SWITCH-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02583685
Recruitment Status : Recruiting
First Posted : October 22, 2015
Last Update Posted : February 28, 2019
Sponsor:
Collaborators:
Beijing 302 Hospital
Nanfang Hospital of Southern Medical University
Information provided by (Responsible Party):
Humanity and Health Research Centre

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Infection Drug: PR4 + LDV/SOF + ASV 4 wk Drug: PR4 + LDV/SOF + SMV 4 wk Drug: PR4 + LDV/SOF + ASV 6 wk Drug: PR4 + LDV/SOF + SMV 6 wk Drug: PR4 + LDV/SOF + ASV 8 wk Drug: PR4 + LDV/SOF + SMV 8 wk Drug: PR4 + LDV/SOF + ASV 12 wk Drug: PR4 + LDV/SOF + SMV 12 wk Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Study Start Date : May 2015
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Experimental: PR4 + LDV/SOF + ASV 4 wk
Participants treated with 4 weeks pegylated interferon and ribavirin and plasma HCV RNA <25 IU/ml by week 2 will receive LDV/SOF + ASV for 4 weeks.
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.
Other Names:
  • Pegasys®
  • Copegus®
  • Harvoni®
  • Sunvepra®

Experimental: PR4 + LDV/SOF + SMV 4 wk
Participants treated with 4 weeks pegylated interferon and ribavirin and plasma HCV RNA <25 IU/ml by week 2 will receive LDV/SOF + SMV for 4 weeks.
Drug: 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.
Other Names:
  • Pegasys®
  • Copegus®
  • Harvoni®
  • OLYSIO®

Experimental: PR4 + LDV/SOF + ASV 6 wk
Participants treated with 4 weeks pegylated interferon and ribavirin and plasma HCV RNA <25 IU/ml by week 4 will receive LDV/SOF + ASV for 6 weeks.
Drug: 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.
Other Names:
  • Pegasys®
  • Copegus®
  • Harvoni®
  • Sunvepra®

Experimental: PR4 + LDV/SOF + SMV 6 wk
Participants treated with 4 weeks pegylated interferon and ribavirin and plasma HCV RNA <25 IU/ml by week 4 will receive LDV/SOF + SMV for 6 weeks.
Drug: 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.
Other Names:
  • Pegasys®
  • Copegus®
  • Harvoni®
  • OLYSIO®

Experimental: PR4 + LDV/SOF + ASV 8 wk
Participants treated with 4 weeks pegylated interferon and ribavirin and plasma HCV RNA > 2 log drop but ≥25 IU/ml by week 4 will receive LDV/SOF + ASV for 8 weeks.
Drug: 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.
Other Names:
  • Pegasys®
  • Copegus®
  • Harvoni®
  • Sunvepra®

Experimental: PR4 + LDV/SOF + SMV 8 wk
Participants treated with 4 weeks pegylated interferon and ribavirin and plasma HCV RNA > 2 log drop but ≥25 IU/ml by week 4 will receive LDV/SOF + SMV for 8 weeks.
Drug: 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.
Other Names:
  • Pegasys®
  • Copegus®
  • Harvoni®
  • OLYSIO®

Experimental: PR4 + LDV/SOF + ASV 12 wk
Participants treated with 4 weeks pegylated interferon and ribavirin and plasma HCV RNA <2 log drop by week 4 will receive LDV/SOF + ASV for 12 weeks.
Drug: 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.
Other Names:
  • Pegasys®
  • Copegus®
  • Harvoni®
  • Sunvepra®

Experimental: PR4 + LDV/SOF + SMV 12 wk
Participants treated with 4 weeks pegylated interferon and ribavirin and plasma HCV RNA <2 log drop by week 4 will receive LDV/SOF + SMV for 12 weeks.
Drug: 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.
Other Names:
  • Pegasys®
  • Copegus®
  • Harvoni®
  • OLYSIO®




Primary Outcome Measures :
  1. Proportion of participants with sustained virologic response 12 weeks (SVR12) after discontinuation of therapy [ 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 ]

Secondary Outcome Measures :
  1. Proportion of participants with unquantifiable HCV viral load at specified time points during and after treatment [ Time Frame: Baseline up to Week 24 ]
  2. Treatment adherence [ Time Frame: Baseline to Week 12 ]
    To evaluate the proportion of patients adherent to therapy (both on-treatment adherence and treatment discontinuation)

  3. Change in health related quality of life evaluated with questionnaires [ Time Frame: Up to Posttreatment Week 24 ]
    To evaluate the change in health-related quality of life during and after treatment with questionnaires

  4. Change in mental health evaluated with questionnaires [ Time Frame: Up to Posttreatment Week 24 ]
    To evaluate the change in mental health during and after treatment with questionnaires

  5. Liver disease progression [ Time Frame: Up to 10 years ]
    Liver disease progression is a composite endpoint measured by laboratory parameters (alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, albumin, platelets, prothrombin time (PT) and α-fetoprotein) and observed or reported clinical signs and symptoms.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT02583685


Contacts
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Contact: Chen WANG, MD, PhD +85228613777 doc_chengwang@126.com
Contact: Yudong WANG, PhD +85228613777 ydwang@connect.hku.hk

Locations
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China, Beijing
Liver Fibrosis Diagnosis and Treatment Centre, 302 Hospital Recruiting
Beijing, Beijing, China, 100039
Contact: Guofeng Chen, MD    (8610)66933427    guofengchen302@163.com   
Principal Investigator: George KK Lau, MD         
Principal Investigator: Guofeng Chen, MD         
China, Hong Kong
Humanity and Health GI and Liver Centre Recruiting
Hong Kong, Hong Kong, China, 00852
Contact: George KK Lau, MD    (852)28613777    gkklau@netvigator.com   
Principal Investigator: George KK Lau, MD         
Sponsors and Collaborators
Humanity and Health Research Centre
Beijing 302 Hospital
Nanfang Hospital of Southern Medical University
Investigators
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Principal Investigator: George Lau Humanity and Health GI and Liver Centre

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Responsible Party: Humanity and Health Research Centre
ClinicalTrials.gov Identifier: NCT02583685    
Other Study ID Numbers: H&H_SWITCH-1
First Posted: October 22, 2015    Key Record Dates
Last Update Posted: February 28, 2019
Last Verified: February 2019
Additional relevant MeSH terms:
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Infection
Hepatitis C
Hepatitis C, Chronic
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis, Chronic
Interferons
Ribavirin
Peginterferon alfa-2a
Ledipasvir, sofosbuvir drug combination
Simeprevir
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Protease Inhibitors
Enzyme Inhibitors