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A Randomized Trial of 24-Week Versus 48-Week Courses of Peginterferon Plus Ribavirin for HCV Genotype-6 Patients

NCT ID: NCT01263860

Last Updated: 2014-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

242 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2014-06-30

Brief Summary

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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

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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.

Conditions

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Chronic Hepatitis C

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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24-Week treatment group

Genotype 6 chronic hepatitis C patients with rapid virological response(undetectable HCV RNA at weeks 4) in this group will be treated with Peginterferon alfa-2a plus ribavirin for an additional 20 weeks

Group Type EXPERIMENTAL

Peginterferon alfa2a

Intervention Type DRUG

patients receive a dose of 180 µg of PEGASYS once a week for 24 weeks

Ribavirin

Intervention Type DRUG

patients receive a dose 800 to 1200 mg of ribavirin once a day(according to weight) for 24 weeks

48-Week treatment group

Genotype 6 chronic hepatitis C patients with rapid virological response(undetectable HCV RNA at weeks 4) in this group will be treated with Peginterferon alfa-2a plus ribavirin for an additional 44 weeks

Group Type ACTIVE_COMPARATOR

Peginterferon alfa2a

Intervention Type DRUG

patients receive a dose of 180 µg of PEGASYS once a week for 48 weeks

Ribavirin

Intervention Type DRUG

patients receive a dose 800 to 1200 mg of ribavirin once a day(according to weight) for 48 weeks

Interventions

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Peginterferon alfa2a

patients receive a dose of 180 µg of PEGASYS once a week for 24 weeks

Intervention Type DRUG

Ribavirin

patients receive a dose 800 to 1200 mg of ribavirin once a day(according to weight) for 24 weeks

Intervention Type DRUG

Peginterferon alfa2a

patients receive a dose of 180 µg of PEGASYS once a week for 48 weeks

Intervention Type DRUG

Ribavirin

patients receive a dose 800 to 1200 mg of ribavirin once a day(according to weight) for 48 weeks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Third Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role lead

Responsible Party

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Cai Qingxian

Sun Yat-Sen University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gao Zhiliang, Doctor

Role: STUDY_CHAIR

The Third Affliated Hospital of Sun Yat-sen University

Zhao Zhixin, Doctor

Role: STUDY_DIRECTOR

The Third Affliated Hospital of Sun Yat-sen University

Zhang Xiaohong, Doctor

Role: PRINCIPAL_INVESTIGATOR

The Third Affliated Hospital of Sun Yat-sen University

Xu Min, Doctor

Role: PRINCIPAL_INVESTIGATOR

The Eighth People's Hospital of Guangzhou

Wei min, Doctor

Role: PRINCIPAL_INVESTIGATOR

Zhongshan second people's hospital

Huang mingshou, Bachelor

Role: PRINCIPAL_INVESTIGATOR

Panyu People's Hospital

Locations

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The Eighth People's Hospital of Guangzhou

Guangzhou, Guangdong, China

Site Status

The Third Affliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status

Panyu People's Hospital

Guangzhou, Guangdong, China

Site Status

Zhongshan second people's hospital

Zhongshan, Guangdong, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 26509605 (View on PubMed)

Other Identifiers

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TAH115G6HCV

Identifier Type: -

Identifier Source: org_study_id