MedTrace Logo

Australian Trial in Acute Hepatitis C

NCT00192569 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 167

Last updated 2011-04-15

No results posted yet for this study

Summary

Australian Trial in Acute Hepatitis C (ATAHC)

A prospective non-randomised dual arm longitudinal cohort of newly acquired hepatitis C infection into which participants will be enrolled and then followed at 3 monthly intervals over a 3 year period.

All participants will be offered a 24 week course of pegylated interferon alfa 2a which will be commenced within 12 weeks of screening (patients coinfected with HIV will be offered 24 weeks with pegylated interferon alfa 2a plus ribavirin).

Conditions

  • Hepatitis C

Interventions

DRUG

Pegylated Interferon alfa 2a

PEG-IFN 180 mcg in 0.5 ml (prefilled syringes) administered subcutaneously (SC) once weekly

DRUG

Ribavirin (HIV conifected patients only)

* genotype 1: 1000mg or 1200mg p.o. daily in split doses (1000mg for patients weighing \<75kg and 1200mg for patients weighing ≥ 75kg) * Genotypes 2/3: 800mg daily p.o. daily in split doses for genotype 2 and 3 patients

Sponsors & Collaborators

  • The University of New South Wales

    collaborator OTHER

  • National Institutes of Health (NIH)

    collaborator NIH

  • Kirby Institute

    lead OTHER_GOV

Principal Investigators

  • John Kaldor, PhD · National Centre in HIV Epidemiology and Clinical Research.

  • Greg Dore, MB BS FRACP · National Centre in HIV Epidemiology and Clinical Research.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-07-31
Primary Completion
2010-06-30
Completion
2010-06-30

Countries

  • Australia

Study Locations

More Related Trials

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 NCT00192569 on ClinicalTrials.gov