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

Sun Yat-sen University

Status and phase: Unknown; Phase 3

Conditions: Chronic Hepatitis C

Treatments: Drug: Ribavirin; Drug: Peginterferon alfa2a

Study type: Interventional

Funder types: Other

Identifiers

NCT01441804

TAHG1IL-28BCC

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 16 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

24-Week treatment group

Experimental group

Description:

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

Treatment:

Drug: Peginterferon alfa2a

Drug: Ribavirin

Drug: Ribavirin

Drug: Peginterferon alfa2a

48-Week treatment group

Active Comparator group

Description:

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

Treatment:

Drug: Peginterferon alfa2a

Drug: Ribavirin

Drug: Ribavirin

Drug: Peginterferon alfa2a