Overview

This trial is active, not recruiting.

Condition early chronic hepatitis c
Treatment tpv/peg-ifn/rbv
Phase phase 4
Sponsor Kirby Institute
Collaborator Janssen-Cilag Ltd.
Start date January 2013
End date June 2015
Trial size 20 participants
Trial identifier NCT01743521, VHCRP1102, VX-950HCP4010

Summary

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy
tpv/peg-ifn/rbv Telaprevir brand name: INCIVO
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.
(Experimental)
12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy
tpv/peg-ifn/rbv Telaprevir brand name: INCIVO
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.
(Experimental)
24 weeks total therapy - TPV/PEG-IFN/RBV for 12 weeks + PEG-IFN/RBV for 12 weeks if undetectable HCV RNA after 8 weeks of therapy
tpv/peg-ifn/rbv Telaprevir brand name: INCIVO
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.

Primary Outcomes

Measure
SVR12
time frame: 12 weeks post-treatment

Secondary Outcomes

Measure
SVR24
time frame: 24 weeks post-treatment
Undetectable HCV RNA (ETR)
time frame: Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)
Undetectable HCV RNA (weeks 1,2,3,4,5,6,8)
time frame: Week 1,2,3,4,5,6 and 8 of therapy
gene IL28B polymorphism
time frame: Baseline
Baseline resistance-associated variants
time frame: Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)
Resistance-associated variants
time frame: Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)
Indicators of toxicity (ALT, HB, Neutrophils, Platelets)
time frame: Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)
Plasma ribavirin levels and haemoglobin
time frame: Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)
CD4 and HIV RNA
time frame: Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

Inclusion Criteria: 1. Provision of written, informed consent. 2. HCV genotype 1 infection 3. Quantifiable HCV RNA at screening and baseline (>10,000 IU/ml) 4. Recent hepatitis C infection with an estimated duration of Infection >6 months and ≤ 18 months defined as A) i) First anti-HCV antibody or HCV RNA positive within the previous 6 months and ii) Documented anti-HCV antibody negative or HCV RNA negative within the 24 months prior to anti-HCV antibody positive result OR B) i) First anti-HCV antibody or HCV RNA positive within the previous 6 months and ii) acute clinical hepatitis (jaundice or ALT> 10 X ULN) within the 12 months prior to first positive HCV antibody or HCV RNA with no other cause of acute hepatitis identifiable 5. Compensated liver disease (Child-Pugh A) 6. Negative pregnancy test at screening and 24 hours prior to the first dose of study drugs. 7. If heterosexually active, a female subject of childbearing potential and a nonvasectomized male subject who has a female partner of childbearing potential must agree to use 2 effective contraceptives from screening onwards until 6 months (female subject) or 7 months (male subject) after RBV therapy has ended. Note: Hormonal contraceptives may be continued but may not be reliable during telaprevir dosing and for 2 months following cessation of telaprevir. Therefore, subjects should agree to use 2 effective non-hormonal methods of contraception during telaprevir combination therapy and for 2 months after the last intake of telaprevir. As of two months after completion of telaprevir hormonal contraceptives can again be used as one of the two required effective methods of birth control. 8. Subject is judged to be medically stable on the basis of physical examination, medical history and vital signs. 9. Adequate English to provide written, informed consent and to provide reliable responses to the study interview Additional inclusion criteria for HIV positive individuals - Confirmed HIV infection > 6 months duration - CD4 > 200 cells/mm3 and HIV < 50 c/ml on stable ART at least 3 months prior to treatment - Or - CD4 >= 500 cells/mm3 and HIV VL < 100,000 not on ART - If on ART must be taking a regimen containing an accepted* combination of the following drugs: tenofovir ( TDF), lamivudine ( 3TC), emtricitabine (FTC), efavirenz (EFV), abacavir (ABC), raltegravir (RAL), etravirine (ETV), rilpivirine (RIL), ritonavir boosted atazanavir (r/ATZ) * Combination must be supported by current HIV treatment guidelines Exclusion Criteria: - Individuals considered by the study investigators to be unlikely to participate in intensive follow-up and/or unwilling to provide extra blood samples - Current injecting drug use (any injecting within previous 4 weeks) - Standard exclusions to Peg-interferon (PEG-IFN), Ribavirin (RBV) and Telaprevir (TPV) therapy

Additional Information

Official title DAA Based Therapy for Recently Acquired Hepatitis C
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2015.
Information provided to ClinicalTrials.gov by Kirby Institute.