Welcome
Support Centre
31 October 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

Registration
New application
Updating record

Information
introduction
governing board
ISRCTN FAQs
data set
letter of agreement
request information
guidance notes
statistics

[ Print-friendly version ]
Short versus standard treatment with pegylated interferon alfa-2a plus ribavirin in patients with hepatitis C virus genotype 2 or 3: the CLEO trial
ISRCTN ISRCTN29259563
DOI 10.1186/ISRCTN29259563
ClinicalTrials.gov identifier
EudraCT number
Public title Short versus standard treatment with pegylated interferon alfa-2a plus ribavirin in patients with hepatitis C virus genotype 2 or 3: the CLEO trial
Scientific title Short versus standard treatment with pegylated interferon alfa-2a plus ribavirin in patients with hepatitis C virus genotype 2 or 3: a randomised controlled trial
Acronym Study short treatment (reduction duration)
Serial number at source 22/2006
Study hypothesis To verify if a 12-week regimen of a combination of pegylated interferon alfa-2a and ribavirin was as efficacious as a 24-week regimen in patients with hepatitis C virus (HCV) genotype 2 or 3.
Lay summary
Ethics approval Ethical Committee of Azienda Ospedaliera San Camillo Forlanini approved in 2005 (ref: 489)
Study design Randomised controlled trial
Countries of recruitment Italy
Disease/condition/study domain Chronic hepatitis C genotype 2 and 3
Participants - inclusion criteria 1. HCV ribonucleic acid (RNA) positive
2. HCV genotype 2 or 3
3. Elevated alanine aminotransferase (greater than 40 IU/L) at least 8 months prior to study entry
4. Histologically proven chronic HCV hepatitis
5. Naive to treatment
6. Aged 20 - 68 years, either sex
Participants - exclusion criteria 1. Known to have injected drugs or alcohol abuse (greater than 40 g ethanol/day) within the 6 months prior to study entry
2. Poorly controlled psychiatric illness
3. Decompensated cirrhosis
4. Positive for human immunodeficiency antibody virus or positive for hepatitis B surface antigen
5. Pregnancy, lactation
6. Impaired renal function
7. Other concurrent medical conditions of the liver different from HCV infection
Anticipated start date 10/05/2006
Anticipated end date 10/01/2008
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 220
Interventions Patients fulfilling the selection criteria received in an open-label fashion pegylated interferon alfa-2a at a dose of 180 µg subcutaneously once weekly and oral ribavirin, at a dosage of 1000 mg/day (for those with a weight of less than 75 kg) or 1200 mg/day (for those with a weight of greater than or equal to 75 kg). Patients with rapid virological response (RVR) defined as HCVRNA less than 50 IU/ml after 4 weeks of treatment, were randomly assigned in a 1:1 ratio to receive a treatment either for 12 weeks. Patients without RVR were treated for a standard period of 24 weeks.
Primary outcome measure(s) Sustained virological response (SVR) which was defined as undetectable plasma HCVRNA (less than 50 IU/ml) 24 weeks after the end of treatment.
Secondary outcome measure(s) 1. Virological response rates (HCVRNA negative in serum with a detection limit of 50 IU/ml) at the end of therapy
2. Severity and frequency of adverse events
Sources of funding Club Hepatology Hospital (Club Epatologi Ospedalieri [CLEO]) Group (Italy)
Trial website
Publications
Contact name Prof  Adriano M  Pellicelli
  Address Via Terni 97 (private address)
  City/town Rome
  Zip/Postcode 00182
  Country Italy
Sponsor Club Hepatology Hospital (Club Epatologi Ospedalieri [CLEO]) Group (Italy)
  Address Via di Villa Troili 6
  City/town Rome
  Zip/Postcode 00163
  Country Italy
  Sponsor website: http://www.clubepatologiospedalieri.org/online/
Date applied 15/01/2010
Last edited 22/01/2010
Date ISRCTN assigned 22/01/2010
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.