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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00077649
First received: February 10, 2004
Last updated: September 22, 2014
Last verified: September 2014
  Purpose

The effects of treatment with different doses of PEGASYS in combination with dif ferent 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 tre atment with interferon. The anticipated time on study treatment is 3-12 months a nd the target sample size is 100-500 individuals.


Condition Intervention Phase
Hepatitis C, Chronic
Drug: Copegus
Drug: peginterferon alfa-2a [Pegasys]
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Viral response compared to baseline\n [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • SVR and end of treatment virological response\n\n [ Time Frame: Week 48 ] [ Designated as safety issue: No ]
  • Virological response [ Time Frame: Week 60 ] [ Designated as safety issue: No ]
  • AEs, laboratory parameters, vital signs, Beck Depression Inventory [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 188
Study Start Date: January 2004
Study Completion Date: April 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: Copegus
600mg po bid for 48 weeks
Other Name: PEGASYS
Drug: peginterferon alfa-2a [Pegasys]
180 micrograms sc weekly for 48 weeks
Experimental: 2 Drug: Copegus
800mg po bid for 48 weeks
Drug: peginterferon alfa-2a [Pegasys]
180 micrograms sc weekly for 48 weeks
Experimental: 3 Drug: Copegus
600mg po bid for 48 weeks
Other Name: PEGASYS
Drug: peginterferon alfa-2a [Pegasys]
270 micrograms sc weekly for 48 weeks
Experimental: 4 Drug: Copegus
800mg po bid for 48 weeks
Drug: peginterferon alfa-2a [Pegasys]
270 micrograms sc weekly for 48 weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00077649

  Show 25 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00077649     History of Changes
Other Study ID Numbers: NV17318
Study First Received: February 10, 2004
Last Updated: September 22, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Peginterferon alfa-2a
Interferon-alpha
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 30, 2014