Condition category
Infections and Infestations
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
01/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Howard Thomas

ORCID ID

Contact details

Department of Medicine
St Mary's Hospital
Imperial College School of Medicine at St Mary's
10th Floor QEQM Wing
South Wharf Road
London
W2 1PG
United Kingdom
+44 (0)20 7886 6454
h.thomas@imperial.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 95/24/03

Study information

Scientific title

Acronym

Study hypothesis

A multicentre, randomised study comparing interferon and ribavarin with no treatment for patients with mild chronic Hepatitis C.

Ethics approval

Added as of 23/07/2007: Ethics committee approval was obtained both centrally (MREC/98/2/12) and from each Local Centre Committee (LREC).

Study design

Multicentre, randomised, controlled, non-blinded trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Infection and infestations: Hepatitis

Intervention

Please note that, as of 14 January 2008, the anticipated end date of this trial has been updated from 31 July 2001 to 31 October 2003.

Interventions:
1. Interferon and ribavarin
2. No treatment

Intervention type

Drug

Phase

Not Specified

Drug names

Interferon and ribavarin

Primary outcome measures

Primary outcome measure updated as of 24/07/2007:
Sustained Virological Response (SVR) at 24 weeks post-treatment.

Primary outcome measure provided at time of registration:
Analysis includes health economics, quality of life and virological end points.

Secondary outcome measures

Secondary outcome measures added as of 24/07/2007:
1. Baseline factors predicting SVR
2. Changes in histopathology
3. Health-Related Quality of Life (HRQoL)
4. Viral kinetics: the relationship of early viral kinetics to final treatment outcome
5. Adverse events

Overall trial start date

01/08/1998

Overall trial end date

31/10/2003

Reason abandoned

Eligibility

Participant inclusion criteria

Inclusion criteria updated as of 24/07/2007:
1. Adult, male or female, minimum age of 18 years
2. Serum positive for HCV by quantitative Polymerase Chain Reaction (qPCR) assay
3. Liver biopsy within 1 year before entry to the protocol. Histological diagnosis consistent with mild chronic hepatitis (Ishak necroinflammatory score <4, fibrosis score <3)
4. Compensated liver disease with the following minimum haematological, biochemical and serological criteria at the screening visit:
4.1. Haemoglobin (Hb) ≥12 g dl–1 for women and ≥13 g dl–1 for men
4.2. White Blood Cell count (WBC) ≥ 3000 mm–3
4.3. Granulocyte count ≥1500 mm–3
4.4. Platelets ≥100,000 mm–3
4.5. Prothrombin time/ International Normalised Ratio (INR) within normal limits
4.6. Bilirubin within normal limits (unless non-hepatitis-related factors such as Gilbert’s disease explain a rise)
4.7. Albumin stable and within normal limits
4.8. Serum creatinine within normal limits
4.9. Fasting blood sugar within normal limits for non-diabetic patients
4.10. Glycosylated haemoglobin (HbA1c) <8.5% for diabetic patients (whether diet controlled or on medication)
4.11. TSH within normal limits (patients requiring medication to maintain Thyroid-Stimulating Hormone (TSH) levels in the normal range were eligible if all other inclusion/exclusion criteria were met)
4.12. AntiNuclear Antibodies (ANA) <1:160
4.13. Anti-HIV antibody negative
4.14. Serum hepatitis B surface antigen (HBsAg) negative
5. Confirmation and documentation that sexually active patients of childbearing potential were practising adequate contraception during the treatment period and for 6 months after discontinuation of therapy. A serum pregnancy test was obtained at entry before the initiation of treatment and had to be negative. Female patients could not breast-feed.

Inclusion criteria provided at time of registration:
Patients with hepatitis C

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

204

Participant exclusion criteria

Exclusion criteria added as of 24/07/2007:
1. Prior treatment with interferon-alpha or ribavirin
2. Hypersensitivity to interferon-alpha or ribavirin
3. Participation in any other clinical trial within 30 days of entry to this protocol
4. Treatment with any investigational drug within 30 days of entry to this protocol
5. Prior treatment for hepatitis with any other antiviral or immunomodulatory drug within the previous 2 years
6. Any other cause for the liver disease other than chronic hepatitis C, including but not limited to:
6.1. Coinfection with hepatitis B virus
6.2. Haemochromatosis (iron deposition >2+ in liver parenchyma)
6.3. Alpha1-antitrypsin deficiency
6.4. Wilson’s disease
6.5. Autoimmune hepatitis
6.6. Alcoholic liver disease
6.7. Obesity-induced liver disease
6.8. Drug-related liver disease
7. Haemophilia or any other condition preventing the patient from having a liver biopsy, including anticoagulant therapy
8. Haemoglobinopathies (e.g. thalassaemia)
9. Evidence of advanced liver disease, such as history or presence of ascites, bleeding varices, encephalopathy
10. Patients with organ transplants
11. Any known pre-existing medical condition that could interfere with the patient’s participation in and completion of the
protocol such as:
11.1. Pre-existing psychiatric condition (e.g. severe depression, or a history of severe psychiatric disorder)
11.2. CNS trauma or seizure disorder requiring medication
11.3. Significant cardiovascular dysfunction within the past 6 months (e.g. angina, congestive cardiac failure, recent myocardial infarction, severe hypertension or significant arrhythmia)
11.4. Patients with an ECG showing clinically significant abnormalities
11.5. Poorly controlled diabetes mellitus
11.6. Chronic pulmonary disease (e.g. chronic obstructive pulmonary disease)
11.7. Immunologically mediated disease (e.g. inflammatory bowel disease, Crohn’s disease, ulcerative colitis, rheumatoid arthritis, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, autoimmune haemolytic anaemia, scleroderma, severe psoriasis, cryoglobulinaemia with vasculitis)
11.8. Any medical condition requiring, or likely to require during the course of the study, chronic systemic administration of steroids
11.9. Gout
12. Substance abuse, such as excessive alcohol intake (>50 g day–1) or erratic use of intravenous or inhaled drugs
13. Patients with clinically significant retinal abnormalities
14. Any other condition which in the opinion of the investigator would make the patient unsuitable for enrolment or that could interfere with the patient participating in or completing the protocol

Recruitment start date

01/08/1998

Recruitment end date

31/10/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Medicine
London
W2 1PG
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/en/index.htm

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2006 HTA monograph in http://www.ncbi.nlm.nih.gov/pubmed/16750059

Publication citations

  1. HTA monograph

    Wright M, Grieve R, Roberts J, Main J, Thomas HC, , Health benefits of antiviral therapy for mild chronic hepatitis C: randomised controlled trial and economic evaluation., Health Technol Assess, 2006, 10, 21, 1-113, iii.

Additional files

Editorial Notes