A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With COPEGUS (Ribavirin) in Interferon-Naive Patients With Chronic Hepatitis C Infection (CHC).

Hepatitis C, Chronic Clinical Trial

Official title:

A Randomized, Double-blind Study of the Effect of PEGASYS and Ribavirin Combination Therapy on Viral Kinetics and Virologic Response in Interferon-naïve Patients With Chronic Hepatitis C Genotype 1 Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00077649
• Other study ID #: NV17318
• Status: Completed
• Phase: Phase 4
• First received: February 10, 2004
• Last updated: October 1, 2015
• Start date: January 2004
• Est. completion date: April 2006

Study information

• Verified date: October 2015
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The effects of treatment with different doses of PEGASYS in combination with different doses of ribavirin will be evaluated in patients with CHC genotype 1 who have a high viral titer, body weight greater than 85kg (187lbs) and no prior treatment with interferon. The anticipated time on study treatment is 3-12 months and the target sample size is 100-500 individuals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 188
• Est. completion date: April 2006
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult patients >=18 years of age;

• body weight >85kg (187lbs);

• CHC (genotype 1);

• liver biopsy (in <24 calendar months of first dose), with results consistent with CHC infection;

• use of 2 forms of contraception during study and 6 months after the study in both men and women.

Exclusion Criteria:

• women who are pregnant or breastfeeding;

• male partners of women who are pregnant;

• conditions associated with decompensated liver disease;

• other forms of liver disease, including liver cancer;

• human immunodeficiency virus infection;

• previous treatment with an interferon, ribavirin, viramidine, levovirin or amantadine.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• Copegus
600mg po bid for 48 weeks
• Copegus
800mg po bid for 48 weeks
• peginterferon alfa-2a [Pegasys]
180 micrograms sc weekly for 48 weeks
• peginterferon alfa-2a [Pegasys]
270 micrograms sc weekly for 48 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Viral response compared to baseline\n		Week 24	No
Secondary	SVR and end of treatment virological response\n\n		Week 48	No
Secondary	Virological response		Week 60	No
Secondary	AEs, laboratory parameters, vital signs, Beck Depression Inventory		Throughout study	No