An Observational Study To Assess Liver Fibrosis Stages in Patients With Chronic Hepatitis C Infection

Browse trials for

• Hepatitis A 2,709
• Hepatitis C 2,321
• Hepatitis C, Chronic 1,073
• Hepatitis 3,380
• Liver Cirrhosis 1,642

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's enrollment of 123 is below the median of 250 across 687 observational studies indexed under Hepatitis A.

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.

Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.

Study population

Groups and cohorts

• Cohort

Primary outcomes

1. Correlation of liver elasticity with liver biopsy performed no later than 3 months before study start

   Time frame: 24 months

2. Correlation of liver elasticity evolution with viral kinetics

   Time frame: 24 months

Secondary outcomes

1. Safety: incidence of adverse events

   Time frame: 24 months

2. Correlation of liver fibrosis stages with sustained virological response (SVR)

   Time frame: 24 months

3. Correlation of patients characteristics with sustained virological response

   Time frame: 24 months

4. Hepatic transient elastography (M-transducer)

   Time frame: 24 months

5. Hepatic transient elastography (XL-transducer)

   Time frame: 24 months

6. Correlation of hepatic steatosis score with sustained virological response

   Time frame: 24 months

7. Correlation of liver steatosis measured by Controlled Attenuation Parameter (CAP) with that obtained by liver biopsy

   Time frame: 24 months

8. Correlation of liver stiffness of HCV monoinfected patients with HCV/HIV co-infected patients

   Time frame: 24 months