Clinical trial NCT02583685: Switching Regimen in Treating Cirrhotic HCV GT1b Subjects
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Hepatitis C Infection
Lead sponsor: Humanity and Health Research Centre
Sponsor class: OTHER
Collaborators: name: Beijing 302 Hospital
name: Nanfang Hospital, Southern Medical University
First posted: 2015-10-22
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Proportion of participants with sustained virologic response 12 weeks (SVR12) after discontinuation of therapy
timeFrame: Post treatment Week 12
measure: Proportion of participants with adverse events leading to permanent discontinuation of study drug(s)
timeFrame: Baseline up to Week 24
Secondary outcomes:
measure: Proportion of participants with unquantifiable HCV viral load at specified time points during and after treatment
timeFrame: Baseline up to Week 24
measure: Treatment adherence
timeFrame: Baseline to Week 12
measure: Change in health related quality of life evaluated with questionnaires
timeFrame: Up to Posttreatment Week 24
measure: Change in mental health evaluated with questionnaires
timeFrame: Up to Posttreatment Week 24
measure: Liver disease progression
timeFrame: Up to 10 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Liver Fibrosis Diagnosis and Treatment Centre, 302 Hospital
state: Beijing
city: Hong Kong
country: China
facility: Humanity and Health GI and Liver Centre
state: Hong Kong
Study officials:
affiliation: Humanity and Health GI and Liver Centre
name: George Lau
role: PRINCIPAL_INVESTIGATOR
References: