Condition category
Digestive System
Date applied
15/01/2010
Date assigned
22/01/2010
Last edited
22/01/2010
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 Adriano M Pellicelli

ORCID ID

Contact details

Via Terni 97 (private address)
Rome
00182
Italy

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

22/2006

Study information

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)

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.

Ethics approval

Ethical Committee of Azienda Ospedaliera San Camillo Forlanini approved in 2005 (ref: 489)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Chronic hepatitis C genotype 2 and 3

Intervention

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.

Intervention type

Drug

Phase

Phase IV

Drug names

Pegylated interferon alfa-2a, ribavirin

Primary outcome measures

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 measures

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

Overall trial start date

10/05/2006

Overall trial end date

10/01/2008

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

220

Participant 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

Recruitment start date

10/05/2006

Recruitment end date

10/01/2008

Locations

Countries of recruitment

Italy

Trial participating centre

Via Terni 97 (private address)
Rome
00182
Italy

Sponsor information

Organisation

Club Hepatology Hospital (Club Epatologi Ospedalieri [CLEO]) Group (Italy)

Sponsor details

Via di Villa Troili 6
Rome
00163
Italy

Sponsor type

Hospital/treatment centre

Website

http://www.clubepatologiospedalieri.org/online/

Funders

Funder type

Research organisation

Funder name

Club Hepatology Hospital (Club Epatologi Ospedalieri [CLEO]) Group (Italy)

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

Publication citations

Additional files

Editorial Notes