Analysis of the Duration of Combination Therapy That is Necessary for HCV Genotype 1 Eradication - Full Text View

Sponsor:	University College London Hospitals
Information provided by:	University College London Hospitals
ClinicalTrials.gov Identifier:	NCT00152581

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:

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
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 IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Analysis of the Duration of Combination Therapy That is Necessary for HCV Genotype 1 Eradication

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis C

Drug Information available for: Ribavirin Interferon alfa-2a Peginterferon Alfa-2a Interferon alfa-n1 Interferons

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, London
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

Study ID Numbers:	01/0277
Study First Received:	September 7, 2005
Last Updated:	November 29, 2005
ClinicalTrials.gov Identifier:	NCT00152581 History of Changes
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:

Interferon-alpha
Anti-Infective Agents
Liver Diseases
RNA Virus Infections
Immunologic Factors
Hepatitis, Chronic
Flaviviridae Infections
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Hepatitis, Viral, Human
Angiogenesis Inhibitors

Antiviral Agents
Pharmacologic Actions
Hepatitis
Virus Diseases
Digestive System Diseases
Therapeutic Uses
Peginterferon alfa-2a
Growth Inhibitors
Angiogenesis Modulating Agents
Hepatitis C
Interferon Alfa-2a
Hepatitis C, Chronic

ClinicalTrials.gov processed this record on November 09, 2009