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Ribavirin Loading Dose or Priming and Concentration Targeting for HCV Genotype 1

NCT01226771 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2015-03-24

No results posted yet for this study

Summary

This is a randomized, open-label, parallel group, multicenter pilot study evaluating the efficacy and safety of alternative dosing of ribavirin vs. standard of care dosing in combination with peginterferon alpha-2a in interferon naïve patients with chronic hepatitis c genotype 1 infection.

Conditions

  • Hepatitis C

Interventions

DRUG

Ribavirin "loading" dose given

PEG-IFN α-2a 180 μg/week plus loading (≥26 mg/kg/day for 2 weeks followed by ≥13 mg/kg/day) and concentration targeted (≥ 2.5 mg/L, i.e ≥ 10.25 μmol/L, as measured after 4 weeks of therapy) dosing of ribavirin and response guided treatment duration (RVR 24 weeks, non-RVR 48 weeks, pEVR consider 72 weeks), follow-up period 24 weeks

DRUG

"Priming" dose of ribavirin given

Standard-of-care dosing of ribavirin (≥13 mg/kg/day) without PEG-IFN for 4 weeks followed by 24-48 additional weeks of PEG-IFN α-2a 180 μg/week plus standard-of-care dosing of ribavirin (≥13 mg/kg/day) and concentration targeted (≥ 2.5 mg/L, i.e ≥ 10.25 μmol/L, as measured after 28 days after the initiation of ribavirin) dosing of ribavirin and response guided treatment duration (RVR 28 weeks, non-RVR 52 weeks, pEVR consider 76 weeks), follow-up period 24 weeks

DRUG

Group C ("Standard-of-Care")

PEG-IFN α-2a 180 μg/week plus standard-of-care dosing of ribavirin (≥13 mg/kg/day without any measurement of ribavirin concentration) and response guided treatment duration (RVR 24 weeks, non-RVR 48 weeks, pEVR consider 72 weeks), follow-up period 24 weeks

Sponsors & Collaborators

  • The Swedish Research Council

    collaborator OTHER_GOV

  • Roche Pharma AG

    collaborator INDUSTRY

  • Göteborg University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01226771 on ClinicalTrials.gov