Ribavirin, Its Dosing Regime (Ribados)

Maastricht University Medical Centre (MUMC)

Status and phase: Completed; Phase 4

Conditions: Hepatitis C

Treatments: Drug: Ribavirin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00484328

MEC-07-3-007

Details and patient eligibility

About

The purpose of this study is to determine if the medicines for chronic hepatitis C can be taken once daily, instead of twice daily.

Full description

The standard treatment of patients with chronic hepatitis C infection (HCV) is treatment with ribavirin. Actually, the compliance (2x daily) seems to be a problem. To increase patients' compliance, it is investigated if the total dose of ribavirin can be taken once daily.

The pharmacokinetics of ribavirin at different dosage regimes is investigated.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• anti-HCV positivity > 6 months
• Positive HCV-RNA genotype 1 or 4
• Liver biopsy within one year before the start of therapy
• Intention to be treated and participate treatment
• body weight at or above 75 kg

Exclusion criteria

• HIV positive

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: Ribavirin

2

Experimental group

Treatment:

Drug: Ribavirin