Clinical trial NCT01447420: 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)
Official title: A Clinical Trial Comparing the Sustained Virological Response in Terms of Expression Profile of IL- 28B in Genotype 1 HCV-Infected Treatment-Naïve Subjects With Chronic Hepatitis C on Pegasys® (Peginterferon Alfa-2A) Plus Copegus® (Ribavirin)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hepatitis C, Chronic
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-10-06
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Sustained Virological Response Rate in Relation to Interleukin 28B Expression
timeFrame: At Week 72
measure: Percentage of Participants With Incidence of Anemia
timeFrame: Up to Week 72
Secondary outcomes:
measure: Number of Participants With Viral Response Rate (Rapid/Early/End of Treatment) in Relation to IL28-B Expression
timeFrame: Weeks 4, 12, 24, 48, 60 and 72
measure: Number of Participants With Sustained Virological Response and Occurrence of Anemia During The First Month of Treatment and After the First Month of Treatment
timeFrame: Up to Week 72
measure: Number of Participants With Viral Load Reduction (HCV-RNA Levels) at Week 4 and 12
timeFrame: From Baseline (Week 0) to Week 12
Other outcomes:
Locations:
city: Salvador
country: Brazil
state: BA
city: Vitoria
country: Brazil
state: ES
city: Juiz de Fora
country: Brazil
state: MG
city: Rio de Janeiro
country: Brazil
state: RJ
city: Rio de Janeiro
country: Brazil
state: RJ
city: Joinville
country: Brazil
state: SC
city: Sao Jose Do Rio Preto
country: Brazil
state: SC
city: Botucatu
country: Brazil
state: SP
city: Campinas
country: Brazil
state: SP
city: Campinas
country: Brazil
state: SP
city: Santos
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Sao Paulo
country: Brazil
state: SP
city: Sorocaba
country: Brazil
state: SP
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: