A Study of Sustained Virological Response in Relation to IL28-b Expression in Treatment-Naïve Patients With Chronic Hepatitis C Genotype 1 on Combination Treatment With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin)

Hepatitis C, Chronic Clinical Trial

Official title:

Clinical Study to Compare Sustained Virological Response in Function of Expression Profile of IL28-b in naïve Patients With Chronic Infection by HCV Genotype 1, With Hepatitis C, Receiving Pegasys and Ribavirin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01447420
• Other study ID #: ML25592
• Status: Completed
• Phase: Phase 4
• First received: October 4, 2011
• Last updated: December 1, 2015
• Start date: February 2011
• Est. completion date: November 2012

Study information

• Verified date: December 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

This multi-center, open-label study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) and Copegus (ribavirin) in relation to IL28-b gene expression in treatment-naïve patients with chronic hepatitis C genotype 1. Patients will receive Pegasys (180 mcg sc weekly) and Copegus ( 1'000 or 1'200 mg orally daily) for 48 weeks. Anticipated time of study treatment is 48 weeks, follow-up is 24 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 69 Years

Eligibility

Inclusion Criteria:

• Adult patients, >/=18 and <70 years of age at initiation of treatment

• Body weight between 50 kg and 125 kg at baseline

• Chronic hepatitis C, genotype 1

• Chronic liver disease consistent with HCV infection

• Compensated liver disease (Child-Pugh Grade A)

Exclusion Criteria:

• Pregnant or lactating women, and male partners of pregnant women

• Chronic hepatitis C, genotype 2, 3, 4, 5 or 6

• Previous treatment with interferon or ribavirin

• Positive for hepatitis A, hepatitis B or HIV infection

• History or evidence of a medical condition associated with liver disease other than chronic hepatitis C

• Decompensated liver disease and/or liver disease Child-Pugh classification >6

• Hepatocellular carcinoma

• History or evidence of esophageal bleeding

• Hemoglobinopathy, or any other cause for possible hemolysis

• Hb <11 g/dL in women, <12 g/L in males

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic

Intervention

Drug:
• peginterferon alfa-2a
180 mcg sc weekly, 48 weeks
• ribavirin [Copegus]
1'000 or 1'200 mg orally daily, 48 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of sustained virological response (undetectable HCV RNA 24 weeks after end of treatment) in relation to Interleukin 28B (IL28-b) expression		approximately 2 years	No
Primary	Incidence of anemia		approximately 2 years	No
Secondary	Response rate (rapid/early/end of treatment) in relation to IL28-b expression		approximately 2 years	No
Secondary	Correlation between sustained virological response and anemia (Hb levels) during the first month of treatment		approximately 2 years	No
Secondary	Correlation between sustained virological response and anemia (Hb levels) after the first month of treatment		approximately 2 years	No
Secondary	Correlation between viral load (HCV RNA levels) 12 weeks after the end of treatment and sustained virological response		approximately 2 years	No