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

This study is not yet open for participant recruitment.
Verified December 2012 by Kirby Institute
Sponsor:
Collaborator:
Janssen-Cilag Ltd.
Information provided by (Responsible Party):
Kirby Institute
ClinicalTrials.gov Identifier:
NCT01743521
First received: November 28, 2012
Last updated: December 4, 2012
Last verified: December 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Early Chronic Hepatitis C
 Drug: TPV/PEG-IFN/RBV
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: DAA Based Therapy for Recently Acquired Hepatitis C

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kirby Institute:

Primary Outcome Measures:
  • SVR12 [ Time Frame: 12 weeks post-treatment ] [ Designated as safety issue: No ]
    Proportion of subjects achieving SVR 12 (negative qualitative HCV RNA 12 weeks after therapy completion)


Secondary Outcome Measures:
  • SVR24 [ Time Frame: 24 weeks post-treatment ] [ Designated as safety issue: No ]
    To evaluate the proportion of patients with undetectable HCV RNA 24 weeks after therapy completion (SVR24)

  • Undetectable HCV RNA (ETR) [ Time Frame: Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C) ] [ Designated as safety issue: No ]
    To evaluate the proportion of patients with undetectable HCV RNA at end of treatment (ETR)

  • Undetectable HCV RNA (weeks 1,2,3,4,5,6,8) [ Time Frame: Week 1,2,3,4,5,6 and 8 of therapy ] [ Designated as safety issue: No ]
    To evaluate the proportion of patients with undetectable HCV RNA at weeks 1, 2, 3, 4, 5, 6 and 8 of therapy.

  • gene IL28B polymorphism [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    To examine treatment outcome by IL28B polymorphism

  • Baseline resistance-associated variants [ Time Frame: Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C) ] [ Designated as safety issue: No ]
    To correlate the presence and frequency of baseline resistance-associated variants (RAVs) with the response of Telaprevir based therapy for early chronic HCV infection.

  • Resistance-associated variants [ Time Frame: Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C) ] [ Designated as safety issue: No ]
    To examine the emergence of resistance-associated variants during telaprevir based therapy for early chronic infection

  • Indicators of toxicity (ALT, HB, Neutrophils, Platelets) [ Time Frame: Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C) ] [ Designated as safety issue: Yes ]
    To evaluate indicators of toxicity (ALT, HB, Neutrophils, Platelets) during telaprevir based therapy

  • Plasma ribavirin levels and haemoglobin [ Time Frame: Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C) ] [ Designated as safety issue: Yes ]
    To correlate plasma ribavirin levels with treatment outcome and changes in haemoglobin during therapy

  • CD4 and HIV RNA [ Time Frame: Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C) ] [ Designated as safety issue: Yes ]
    In HIV positive participants to evaluate changes in CD4 counts and HIV RNA during telaprevir based therapy


Estimated Enrollment: 20
Study Start Date: January 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A - 8 weeks therapy of TPV/PEG-IFN/RBV

8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy 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.

 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.

Other Names:
  • Telaprevir brand name: INCIVO
  • Ribavirin brand name: COPEGUS
  • PEG-IFN brand name: PEGASYS
Experimental: Group B - 12 weeks total therapy of TPV/PEG-IFN/RBV

12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy 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.

 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.

Other Names:
  • Telaprevir brand name: INCIVO
  • Ribavirin brand name: COPEGUS
  • PEG-IFN brand name: PEGASYS
Experimental: Group C-TPV/PEG-IFN/RBV (12 wks) + PEG-IFN/RBV (12 wks)

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 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.

 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.

Other Names:
  • Telaprevir brand name: INCIVO
  • Ribavirin brand name: COPEGUS
  • PEG-IFN brand name: PEGASYS

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01743521

Locations
Australia, New South Wales
St Vincent's Hospital Not yet recruiting
Sydney, New South Wales, Australia, 2010
Contact: Rebecca Hickey     +61 2 8382 3825     rhickey@stvincents.com.au    
Principal Investigator: Gregory Dore, MBBS FRACP            
Australia, South Australia
Royal Adelaide Hospital Not yet recruiting
Adelaide, South Australia, Australia, 5000
Contact: Catherine Ferguson     +61 8 8222 5635     catherine.ferguson@health.sa.gov.au    
Principal Investigator: David Shaw            
Australia, Victoria
The Alfred Hospital Not yet recruiting
Melbourne, Victoria, Australia, 3004
Contact: Sally von Bibra     +61 3 9282 2261     svonbibra@burnet.edu.au    
Principal Investigator: Margaret Hellard            
Sponsors and Collaborators
Kirby Institute
Janssen-Cilag Ltd.
Investigators
Study Chair: Gail Matthews, MbChB, MRCP, FRACP, PhD The Kirby Institute
  More Information

No publications provided

Responsible Party: Kirby Institute
ClinicalTrials.gov Identifier: NCT01743521     History of Changes
Other Study ID Numbers: VHCRP1102, VX-950HCP4010
Study First Received: November 28, 2012
Last Updated: December 4, 2012
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Kirby Institute:
Hepatitis C
Individualised therapy
Response-guided therapy
Telaprevir
 PEG-IFN
Ribavirin
Hepatitis

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
 RNA Virus Infections
Flaviviridae Infections
Ribavirin
Peginterferon alfa-2a
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013