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Study on chronic hepatitis Ctreatment with interferon alpha, ribavirin and amantadine in naive patients.

Study on chronic hepatitis Ctreatment with interferon alpha, ribavirin and amantadine in naive patients.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON20761
Enrollment
390
Registered
2005-08-25
Start date
2000-02-14
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Chronic hepatitis C

Interventions

One year treatment with interferon/ribavirin and amantadine or placebo.

Sponsors

Dr. K.J. van Erpecum, hoofdonderzoeker Prof. Dr. M. Samsom, hoofdonderzoker UMC Utrecht Huispostnummer F02.618 Postbus 85500 3508 GA Utrecht
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Anti-HCV positivity; >6 months; 2. ALT and/or AST elevation on at least once in the previous 6 months; 3. Positive HCV-RNA; 4. Liver biopsy within one year before the start of therapy in non-cirrhosis; In the case of known cirrhosis, liver biopsy is not necessary; 5. Intention to be treated and participate treatment; 6. Obtained written informed consent.

Exclusion criteria

Exclusion criteria: 1. Age 150 ìmol/L or > 1.70 mg/dl; 7. Haemoglobulin < 6.5 mmol/l or < 10.5 g/dl, white blood cell count < 2,5 x 109/L, neutrophil < 1,5 x 109/L, platelet count < 70 x 109/L; 8. HIV positivity; 9. Chemotherapy, systemical antiviral treatment during the 6 months prior to study entry; 10. Other serious disease (e.g. malignancy, uncontrolled myocardial disease or severe arythmias); 11. Active uncontrolled psychiatric disorders and suicidal leanings; 12. Patients with a history of uncontrolled seizure or other significant CNS dysfunction; 13. Any condition which in the opinion of the (co-)investigator might interfere with the evaluation of the study objectives.

Design outcomes

Primary

MeasureTime frame
Virological response at week 52 and 104.

Contacts

Public ContactK.J. Erpecum, van

University Medical Center Utrecht (UMCU), F02.618, P.O. Box 85500

K.J.vanerpecum@AZU.NL

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)