A Randomized Trial of 24-Week Versus 48-Week Courses of Peginterferon Plus Ribavirin for Patients With Genotype 1 Hepatitis C and IL28B CC Polymorphism

Phase 3

• Conditions: Chronic Hepatitis C
• Interventions: Drug: Peginterferon alfa2a; Drug: Ribavirin

• Registration Number: NCT01441804
• Lead Sponsor: Third Affiliated Hospital, Sun Yat-Sen University

Brief Summary

Patients with HCV genotype 1 and IL28B CC Polymorphism 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

Not available

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-09-24
• Study First Submitted QC: 2011-09-27
• Study First Posted: 2011-09-28
• Status Verified: 2013-09
• Last Update Submitted: 2013-09-28
• Last Update Posted: 2013-10-01
• Primary Completion: 2014-05
• Study Completion: 2014-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Age > 18 years
• Serum Hepatitis C RNA > 10,000IU/mL
• Hepatitis C virus genotype 1
• IL28B CC polymorphism

Exclusion Criteria

• Previous treatment for chronic Hepatitis C

• clinical or biological evidence of acute hepatitis, including serum ALT or AST > 300U/ml

• HIV antibody positive, hepatitis b surface antigen positive or known diagnosis of other chronic liver disease

• Contraindications to PR-based treatment:

  • Uncontrolled psychiatric illness
  • Active substance dependency
  • Known autoimmune disorder
  • Untreated thyroid disease
  • Uncontrolled seizure disorder
  • Pregnancy, lactation or inability to maintain contraception
  • Chronic kidney disease w/ estimated GFR< 60
  • ANC<1.5/nl, Hb<12g/dl, or platelets<75/nl

• Clinical or biochemical evidence of decompensated liver disease including:

  • History of encephalopathy
  • Ascites
  • Variceal bleeding
  • Bilirubin > 3g/dl or INR > 1.5
  • Life threatening disorder with expected median survival less than 5 years
  • Inability to comply with drug regimens or testing schedule required for study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
24-Week treatment group	Peginterferon alfa2a	Genotype 1 chronic hepatitis C patients with IL28B CC Polymorphism and 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
48-Week treatment group	Peginterferon alfa2a	Genotype 1 chronic hepatitis C patients with IL28B CC Polymorphism and 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
24-Week treatment group	Ribavirin	Genotype 1 chronic hepatitis C patients with IL28B CC Polymorphism and 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
48-Week treatment group	Ribavirin	Genotype 1 chronic hepatitis C patients with IL28B CC Polymorphism and 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

Primary Outcome Measures

Name	Time	Method
Sustained virological response (SVR)	24 weeks after the end of treatment	Undetectable HCVRNA in serum(\<15IU/ml) 24 weeks after the end of treatment

Secondary Outcome Measures

Name	Time	Method
Sick leave in patients treated for 24 or 48 weeks treatment	48 weeks
Change in health related quality as measured by short from 36 (SF-36) from baseline to 24 weeks after the end of treatment	baseline, 24 weeks after the end of treatment

Trial Locations

Locations (4)

Zhongshan second people's hospital; 🇨🇳 Zhongshan, Guangdong, China

The Third Affliated Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China

Panyu People's Hospital; 🇨🇳 Guangzhou, Guangdong, China

The Eighth People's Hospital of Guangzhou; 🇨🇳 Guangzhou, Guangdong, China