Clinical trial NCT01263860: A Randomized Trial of 24-Week Versus 48-Week Courses of Peginterferon Plus Ribavirin for HCV Genotype-6 Patients
Official title: A Randomized Trial of 24-Week Versus 48-Week Courses of Peginterferon Plus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Hepatitis C
Lead sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2010-12-21
Enrollment: 242
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: Patients with HCV genotype 6 infection who have a rapid virological response to treatment are randomised to either 24 or 48 weeks HCV treatment. Our hypothesis is that there is no important difference in effect between the two treatment effect.

Detailed description: High rate of infection of Hepatitis C Virus(HCV) Genotype 6 was recently confirmed in Southern China. Recent study implied chronic hepatitis C genotype 6 responds better to the 48-week treatment with pegylated interferon and ribavirin than genotype 1. Approximately 75.7% obtain sustained virological response (HCV RNA undetectable 24 weeks after treatment) to this approach. However, the treatment is associated with many and sometimes serious side effects. In addition, the treatment is costly also in economical terms. Shorter treatment for chronic hepatitis C genotype 6 is necessary to be assessed.

In this randomised,open label,multicenter phase 3 trial with active controls patients are treated with pegylated interferon alfa 2a (180ug/week)and ribavirin(800-1200mg based on weight)for 4 weeks. Those who are HCV RNA negative at week 4 (\<50 IU; Cobas Amplicor Monitor Test, Roche Diagnostic) are defined as rapid virological responders and randomised to either an additional 20 or 44 weeks combination treatment. Patients who are HCV RNA positive are all treated for 44 more weeks. The endpoint is sustained virological response defined as undetectable HCV RNA 24 weeks after end of treatment.

Our hypothesis is that there is no important difference in the effect in the two groups.

This is a non-inferiority trial. The smallest difference considered to be clinically important is 15%. Thus to state "non-inferiority" the 95% confidence interval of the observed difference between the groups shall not overlap 10%. Both intention to treat and and per protocol analyses will be published. Conclusion will be conservative and based on the analysis who detect the biggest difference.

Eligibility criteria: Inclusion Criteria:

* HCV RNA is positive
* Genotype 6
* Treatment naive
* Raised ALT

Exclusion Criteria:

* Active substance abuse
* Poorly controlled psychiatric disease
* HBsAg positive
* Anti-HIV positive
* Suffering from other significant concurrent medical conditions including chronic liver diseases

Primary outcomes:
measure: Sustained virological response (SVR)
timeFrame: 24 weeks after the end of treatment
Secondary outcomes:
measure: Change in health related quality as measured by short from 36 (SF-36) from baseline to 24 weeks after the end of treatment
timeFrame: 24 weeks after the end of treatment
measure: Sick leave in patients treated for 24 or 48 weeks treatment
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Eighth People's Hospital of Guangzhou
state: Guangdong
city: Guangzhou
country: China
facility: The Third Affliated Hospital of Sun Yat-sen University
state: Guangdong
city: Guangzhou
country: China
facility: Panyu People's Hospital
state: Guangdong
city: Zhongshan
country: China
facility: Zhongshan second people's hospital
state: Guangdong
Study officials:
affiliation: The Third Affliated Hospital of Sun Yat-sen University
name: Gao Zhiliang, Doctor
role: STUDY_CHAIR
affiliation: The Third Affliated Hospital of Sun Yat-sen University
name: Zhao Zhixin, Doctor
role: STUDY_DIRECTOR
affiliation: The Third Affliated Hospital of Sun Yat-sen University
name: Zhang Xiaohong, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: The Eighth People's Hospital of Guangzhou
name: Xu Min, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhongshan second people's hospital
name: Wei min, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Panyu People's Hospital
name: Huang mingshou, Bachelor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cai Q, Zhang X, Lin C, Shao X, Guan Y, Deng H, Wei M, Huang M, Ren Z, Lu L, Mei Y, Xu M, Zhu J, Shi H, Lin G, Liu Y, Hu F, Luo Q, Lan Y, Guo F, Zhao Z, Gao Z. 24 versus 48 Weeks of Peginterferon Plus Ribavirin in Hepatitis C Virus Genotype 6 Chronically Infected Patients with a Rapid Virological Response: A Non-Inferiority Randomized Controlled Trial. PLoS One. 2015 Oct 28;10(10):e0140853. doi: 10.1371/journal.pone.0140853. eCollection 2015.