Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:30 PM
Ignite Modification Date:
2025-12-24 @ 1:30 PM
NCT ID:
NCT00375895
Eligibility Criteria:
Inclusion Criteria:
* Adults aged 18 or over,
* Who had been included in the Transpeg 1 study,
* Non-responders after a three month peginterferon alfa-2a / ribavirin bitherapy or with a recurrent disease during the Transpeg 1 maintenance phase, whatever the randomization group (ribavirin or placebo),
* With a positive qualitative PCR at inclusion,
* With a METAVIR histologic score of 1 or more on the last biopsy (done within the 6 months preceding inclusion),
* Treated with tacrolimus for at least 6 months prior to inclusion,
* Having given a written informed consent.
Exclusion Criteria:
* Treatment with peginterferon or ribavirin within the 6 months preceding inclusion,
* Severe hepatocellular failure or decompensated cirrhosis,
* Acute graft rejection within the two months preceding inclusion, or signs of chronic rejection on the last biopsy, or retransplantation since inclusion in the Transpeg 1 study,
* Treatment with cyclosporin for more than 6 months during the 24 months preceding inclusion,
* Treatment with a mTOR inhibitor or with another investigational immunosuppressive drug,
* Positive serology for HIV or HBV,
* Cancer (or history of other malignancy during the last 5 years) except patients transplanted for hepatocellular carcinoma and basocellular or excised spinocellular carcinoma,
* Serious concomitant disease or acute or chronic disorder, other than the current transplant, treated with steroids,
* Serious cardiac pathology within the last 6 months,
* Women with ongoing pregnancy or breast-feeding,
* Serious chronic renal failure (creatinine clearance \< 30 ml/mn),
* Haemoglobin \< 10 g/dl, platelets \< 50 000/mm3 or neutrophils \< 1000 / mm3,
* Abnormal TSH values,
* Inability to cooperate or to communicate with the investigator,
* Contraindications to ribavirin, peginterferon alfa-2a or cyclosporin.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00375895
Study Brief:
Protocol Section:
NCT00375895