NCT00192569

Australian Trial in Acute Hepatitis C

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 167 (actual)
• Sponsor: Kirby Institute · Other Government
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

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).

Detailed description

The main purposes of the study are: * To enrol and follow-up a large group of people with acute hepatitis C infection to examine why some people naturally clear hepatitis C and some don't. * To examine how many people become re-infected after having cleared hepatitis C and to look at why this happened. The study will also offer everyone taking part the option of undergoing a 6 month course of pegylated interferon alfa 2a (plus ribavirin if HIV coinfected) as treatment for hepatitis C. The purpose of this part of the study is: 1\. To examine whether treatment is effective in clearing the virus.

Conditions

• Hepatitis C

Interventions

Type	Name	Description
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

Timeline

• Start date: 2004-07-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2005-09-19
• Last updated: 2011-04-15

Locations

18 sites across 1 country: Australia