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Trial record 90 of 382 for:    IFNA2 AND RBV AND genotype

Analysis of the Duration of Combination Therapy That is Necessary for HCV Genotype 1 Eradication

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00152581
Recruitment Status : Completed
First Posted : September 9, 2005
Last Update Posted : December 1, 2005
Information provided by:
University College London Hospitals

Brief Summary:

Open-label, single centre study evaluating efficacy and viral kinetics of combination PEG-IFNa2a and Ribavirin treatment on CHC genotype 1 patients, administered until viral clearance demonstrated between 4 – 12 weeks, then randomised to further continued combination treatment for one of three defined durations. Followed-up for 24 weeks after treatment cessation.


  1. To determine the necessary duration of combination treatment with Pegylated-Interferon alfa2a (PEGASYS) & Ribavirin in Patients infected with genotype 1, in order to achieve viral clearance
  2. To identify host factors, which are associated with different patterns of virological response to combination treatment (fast responder, slow responder, non-responder). On this basis, to identify possible predictors for the duration of antiviral treatment.

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C, HCV Genotype 1 Drug: Pegylated interferon-alfa2a (Pegasys); ribavirin Phase 4

Detailed Description:

Forty treatment-naïve patients with chronic hepatitis C, all infected with genotype 1, will be entered into this study. All 40 patients will be started on the same regimen of 180mg Pegylated-Interferon alfa2a (PEGASYS) weekly plus Ribavirin 1000-1200mg daily. HCV RNA in the serum will be monitored by qualitative PCR at treatment weeks 4, 8 and 12. Patients who become HCV RNA negative at any of the above time-points (4,8 or 12), will be randomised into one of three groups to continue the same antiviral regimen for an additional 3 month, 6 month or 9 month period. All these patients will subsequently be followed-up and monitored for a further 6 months after stopping all antiviral treatment.

Treatment will be discontinued for patients who remain persistently HCV RNA positive at treatment week 12 and they will be withdrawn from the study protocol.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Analysis of the Duration of Combination Therapy That is Necessary for HCV Genotype 1 Eradication
Study Start Date : April 2002

Primary Outcome Measures :
  1. Sustained virological response (HCV RNA negative) 6 months post-treatment cessation

Secondary Outcome Measures :
  1. Hepatic and serum HCV RNA levels as a predictor for treatment duration
  2. HCV-specific T-cell reactivity as a predictor for treatment duration

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 18 – 65
  • HCV RNA positive
  • HCV genotype 1
  • Histologically proven chronic hepatitis
  • No previous antiviral treatment

Exclusion Criteria:

  • Liver histology showing cirrhosis
  • Decompensated liver function
  • WCC < 1500/mm3 or platelet count <90,000/mm3
  • Co-infection with HIV or HBV/HAV
  • Alcohol intake greater than 40 units/week
  • Current intravenous drug dependence
  • Pregnancy or breast feeding of infants
  • Inadequate contraception
  • Neuropsychiatric disorder
  • Neoplastic disease
  • Other significant medical problems

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00152581

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United Kingdom
Hepatitis Clinic
University College London Hospital, London, United Kingdom, WC1E 6HX
Sponsors and Collaborators
University College London Hospitals
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Principal Investigator: Nikolai V. Naoumov, MD Institute of Hepatology, University College London

Layout table for additonal information Identifier: NCT00152581     History of Changes
Other Study ID Numbers: 01/0277
First Posted: September 9, 2005    Key Record Dates
Last Update Posted: December 1, 2005
Last Verified: September 2005
Keywords provided by University College London Hospitals:
HCV, genotype 1, treatment, HCV kinetics, T-cells
Additional relevant MeSH terms:
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Interferon alpha-2
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis, Chronic
Peginterferon alfa-2a
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs