NCT01743521

DAA Based Therapy for Recently Acquired Hepatitis C (DARE-C)

Direct Acting Antiviral (DAA) Based Therapy for Recently Acquired Hepatitis C

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Kirby Institute · Other Government
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

To examine the safety and efficacy of response guided triple therapy (PEG-IFN, Ribavirin, Telaprevir) for the treatment of early chronic Hepatitis C Virus (HCV) infection.

Detailed description

DARE-C is a prospective open label multi-centre pilot study examining the safety and efficacy of response guided triple therapy (PEG-IFN, Ribavirin and Telaprevir) for the treatment of early chronic HCV genotype 1 infection in individuals with and without HIV infection.

Conditions

• Hepatitis C, Chronic

Interventions

Type	Name	Description
DRUG	TPV/PEG-IFN/RBV	Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily. Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing \<75kg and 1200mg for patients weighing ≥ 75kg). Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly.

Timeline

• Start date: 2013-01-01
• Primary completion: 2015-11-01
• Completion: 2016-01-01
• First posted: 2012-12-06
• Last updated: 2017-03-29
• Results posted: 2016-10-20

Locations

2 sites across 1 country: Australia