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NCT Number: NCT00152581

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

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.

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Key information

Conditions

Chronic Hepatitis C, HCV Genotype 1 Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hepatitis Clinic

University College London Hospital, London, WC1E 6HX, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pegylated interferon-alfa2a (Pegasys); ribavirin

Drug

Primary outcomes

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

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University College London Hospitals

Other

Registry information

Important dates

Study start
2002
First posted
Sep 9, 2005
Registry last updated
Dec 1, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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