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 @ 7:34 PM
Ignite Modification Date:
2025-12-24 @ 7:34 PM
NCT ID:
NCT00351403
Eligibility Criteria:
Inclusion Criteria:
* Patients with a chronic HCV infection (HCV antibodies and HCV RNA positive)
* Presence of a HCV genotype 1 infection
* Presence of a compensated liver disease satisfying following hematological and biochemical minimum criteria: - Hemoglobin value \>= 13 g/dl in men, \>= 12 g/dl in women - Leukocytes \>= 3.000/mm3 or neutrophile granulocytes \> 1.500/mm3 - Thrombocytes \> 80.000/mm3
* Total bilirubin in the normal range
* Albumin in the normal range
* Serum creatinine in the normal range THS in the normal range
* Exclusion of an autoimmune hepatitis
* Alpha-Fetoprotein in the normal range
* Negative HIV test
* Negativity of Hepatitis B surface antigens (Hbs-Ag)
* Normal or elevated ALT/GTP values at screening
* At known diabetes mellitus or hypertension an ophthalmologic examination must be performed
* Liver biopsy within the last 12 months must confirm the diagnoses of a chronic hepatitis
* A confirmation must be given that sexually active patients practice a save method of contraception during the therapy and 6 (women) to 7 (men) months after the therapy
Exclusion Criteria:
* Age \< 18 years, \> 70 years
* Previous treatment of hepatitis c with (Peg)Interferon alfa or (Peg)Interferon alfa/Ribavirin
* Patients with organ transplantations other than cornea or hair
* Infection with HCV genotype 2,3,4,5 or 6
* Pregnant or nursing women
* Any other reason for the liver disease than chronic hepatitis C
* Suspected hypersensitivity to Interferon, Peginterferon or Ribavirin
* Participation in a clinical trial or treatment with an investigational product 30 days before inclusion in this study
* Patients with any kind of hemoglobinopathy
* Documented liver disease in advanced state Liver cirrhosis Child B and C
* Each known and existing clinical conditions that might challenge the participation or completion of this clinical trial as depressions, psychosis, severe psychiatric diseases, suicide ideations CNS traumata or cramps which need medicamentous treatment
* Relevant cardiovascular dysfunctions in the last 6 months or patients with clinically relevant changes in the ECG
* Insufficiently adjusted diabetes mellitus
* Severe chronic lung diseases (as e.g. COPD)
* Immunologic diseases or autoimmune-diseases or any other disease which demand a longtime treatment with corticosteroids during this clinical trial
* Clinically relevant gout
* Abuse of drugs, alcohol or pharmaceuticals
* Patient with clinically relevant changes of the retina
* Missing ability or willingness to understand the purpose of this study or to give a written consent for participating in this study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00351403
Study Brief:
Protocol Section:
NCT00351403