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

This study has been completed.
Sponsor:
Information provided by:
University College London Hospitals
ClinicalTrials.gov Identifier:
NCT00152581
First received: September 7, 2005
Last updated: November 29, 2005
Last verified: September 2005
History of Changes
  Purpose

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.

Objectives:

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Analysis of the Duration of Combination Therapy That is Necessary for HCV Genotype 1 Eradication

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University College London Hospitals:

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

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

Estimated Enrollment: 40
Study Start Date: April 2002
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00152581

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

No publications provided

ClinicalTrials.gov Identifier: NCT00152581     History of Changes
Other Study ID Numbers: 01/0277
Study First Received: September 7, 2005
Last Updated: November 29, 2005
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University College London Hospitals:
HCV, genotype 1, treatment, HCV kinetics, T-cells

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Interferon-alpha
Interferon Alfa-2a
 Interferons
Ribavirin
Peginterferon alfa-2a
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents
Antimetabolites

ClinicalTrials.gov processed this record on May 23, 2013