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 | https://doi.org/10.1186/ISRCTN29259563 |
| Secondary identifying numbers | 22/2006 |
- Submission date
- 15/01/2010
- Registration date
- 22/01/2010
- Last edited
- 29/12/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Adriano M Pellicelli
Scientific
Scientific
Via Terni 97 (private address)
Rome
00182
Italy
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study acronym | Study short treatment (reduction duration) |
| Study objectives | 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(s) | Ethical Committee of Azienda Ospedaliera San Camillo Forlanini approved in 2005 (ref: 489) |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Pegylated interferon alfa-2a, ribavirin |
| Primary outcome measure | 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 study start date | 10/05/2006 |
| Completion date | 10/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 220 |
| Total final enrolment | 210 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 10/05/2006 |
| Date of final enrolment | 10/01/2008 |
Locations
Countries of recruitment
- Italy
Study participating centre
Via Terni 97 (private address)
Rome
00182
Italy
00182
Italy
Sponsor information
Club Hepatology Hospital (Club Epatologi Ospedalieri [CLEO]) Group (Italy)
Hospital/treatment centre
Hospital/treatment centre
Via di Villa Troili 6
Rome
00163
Italy
| Website | http://www.clubepatologiospedalieri.org/online/ |
|---|
Funders
Funder type
Research organisation
Club Hepatology Hospital (Club Epatologi Ospedalieri [CLEO]) Group (Italy)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 19/02/2010 | 29/12/2020 | Yes | No |
Editorial Notes
29/12/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
