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:
2025-12-25 @ 2:27 AM
Ignite Modification Date:
2025-12-25 @ 2:27 AM
NCT ID:
NCT01718834
Eligibility Criteria:
Inclusion Criteria:
* Healthy volunteers including subjects from both sexes,
* 18-55 years of age will be enrolled.
All subjects had to fulfill all inclusion criteria as follows:
* mentally and physically healthy,
* no clinically relevant pathological findings in any of the investigations of the pre-study examination including blood chemistry (liver and kidney function tests),
* differential blood counts,
* coagulation test,
* ultrasensitive C-reactive protein levels. Subjects should be able to provide written informed consents.
Exclusion Criteria:
* pregnant or breast feeding women,
* patients with chronic viral-infections (e.g., HBV, HCV, HIV), evidence of decompensated liver disease, pre-existing hematuria, or proteinuria,
* cryoglobulin levels \> 1% or other immunologically driven diseases,
* schistosomiasis,
* acute infectious illness,
* severe psychiatric disorders,
* current or past history of malignancy and patients who received treatment with interferon or any investigational therapy for hepatitis during the 3 months prior to study entry.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT01718834
Study Brief:
Protocol Section:
NCT01718834