Management and treatment of patients with a (previous) substance dependency and/or marginally housed patients with chronic hepatitis C: a prospective observational registry

Management and treatment of patients with a (previous) substance dependency and/or marginally housed patients with chronic hepatitis C: a prospective observational registry - Fase 3 Project Active Testing.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON33839

Enrollment

Registered

2008-05-29

Start date

2008-06-02

Completion date

Unknown

Last updated

2024-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HCV infection Hepatitis C

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Male and female patients between 18-70 years of age Evidence of chronic hepatitis C by detectable serum HCV-RNA Indication for antiviral therapy of hepatitis C according to current clinical guidelines Adequate contraception

Exclusion criteria

Exclusion criteria: - Other significant medical illness that might interfere with this study. - Hepatocellular carcinoma - History of thyroid disease poorly controlled on prescribed medications. - Severe uncontrolled psychiatric disease. - Any other condition which in the opinion of the registrator would make the patient unsuitable for enrollment, or could interfere with the patient participating in and completing the therapy.

Design outcomes

Primary

Measure	Time frame
Primary objective: · SVR · Compliance to therapy This data is obtained from project active testing phase 3.	—

Secondary

Measure	Time frame
Secondary objective: · Safety: infectious, psychiatric and serious adverse events (phase 3) · Quality of life and psychopathology by psychological assessment using SF-36 and SCL-90 questionnaires (phase 3) · Effect of alcohol use on adherence and success rate (phase 3) · Epidemiology: Prevalence of hepatitis C and HIV in this group (phase 1 & 2) · Evaluate the Project Active Testing (phase 1,2 and 3) o Percentages of successful screening, diagnosis/staging and treatment of chronic hepatitis C o Effect of social support and professional care o Cost-effectiveness o Degree of liver fibrosis	—

Measure

Time frame

Secondary objective: · Safety: infectious, psychiatric and serious adverse events (phase 3) · Quality of life and psychopathology by psychological assessment using SF-36 and SCL-90 questionnaires (phase 3) · Effect of alcohol use on adherence and success rate (phase 3) · Epidemiology: Prevalence of hepatitis C and HIV in this group (phase 1 & 2) · Evaluate the Project Active Testing (phase 1,2 and 3) o Percentages of successful screening, diagnosis/staging and treatment of chronic hepatitis C o Effect of social support and professional care o Cost-effectiveness o Degree of liver fibrosis

—

Countries

Netherlands

Outcome results