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Hepatitis C, ChronicPhase 4DARE-CNCT01743521

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

A Phase 4 study testing TPV/PEG-IFN/RBV in people with Hepatitis C, Chronic, run by Kirby Institute at 2 sites in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Hepatitis C, Chronic
What is being tested?
TPV/PEG-IFN/RBV
Could I receive a placebo?
No, everyone receives an active treatment
How many people
14 participants
Where
2 sitesAustralia
Study dates
Jan 2013to Jan 2016
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Provision of written, informed consent.
  • HCV genotype 1 infection
  • Quantifiable HCV RNA at screening and baseline (>10,000 IU/ml)
  • 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
  • Compensated liver disease (Child-Pugh A)
  • Negative pregnancy test at screening and 24 hours prior to the first dose of study drugs.
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  • 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.
  • Subject is judged to be medically stable on the basis of physical examination, medical history and vital signs.
  • 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 antiretroviral therapy (ART) at least 3 months prior to treatment
  • Or
  • CD4 >= 500 cells/mm3 and HIV viral load (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

Who cannot join

  • 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 Pegylated-interferon (PEG-IFN), Ribavirin (RBV) and Telaprevir (TPV) therapy

Trial locations and contacts

2 sites in 1 country.

Australia2 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • St Vincent's Hospital

    Sydney, New South Wales, 2010

Other trials in Australia

About this study

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

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.

Read the 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.

Being tested
TPV/PEG-IFN/RBV
Keywords
Hepatitis C, Individualised therapy, Response-guided therapy, Telaprevir, PEG-IFN, Ribavirin, Hepatitis
Medical subject headings
Hepatitis C, Chronic, Hepatitis C, Hepatitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TPV/PEG-IFN/RBVDrug

    Also called Telaprevir brand name: INCIVO, Ribavirin brand name: COPEGUS, PEG-IFN brand name: PEGASYS

    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.

Study groups in NCT01743521
Study groupRoleWhat they receive
Group A - 8 weeks total therapyExperimental8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy
Receives: Drug: TPV/PEG-IFN/RBV
Group B - 12 weeks total therapyExperimental12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy
Receives: Drug: TPV/PEG-IFN/RBV
Group C - 24 weeks total therapyExperimental24 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
Receives: Drug: TPV/PEG-IFN/RBV

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. SVR12 (Sustain Virological Response, HCV RNA Undetectable 12 Weeks Post-treatment)

    Proportion of subjects achieving SVR 12 (negative qualitative HCV RNA 12 weeks after therapy completion)

    Measured: 12 weeks post-treatment

Secondary outcomes (14)

  1. SVR24

    To evaluate the proportion of patients with undetectable HCV RNA 24 weeks after therapy completion (SVR24)

    Measured: 24 weeks post-treatment

  2. Undetectable HCV RNA (ETR)

    To evaluate the proportion of patients with undetectable HCV RNA at end of treatment (ETR)

    Measured: Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)

  3. Undetectable HCV RNA (Week 1)

    To evaluate the proportion of patients with undetectable HCV RNA at week 1 of therapy.

    Measured: Week 1 of therapy

  4. Undectectable HCV RNA (Week 2)

    To evaluate the proportion of patients with undetectable HCV RNA at week 1 of therapy.

    Measured: Week 2 of therapy

  5. Undetectable HCV RNA (Week 3)

    To evaluate the proportion of patients with undetectable HCV RNA at week 3 of therapy.

    Measured: Week 3 of therapy

  6. Undetectable HCV RNA (Week 4)

    To evaluate the proportion of patients with undetectable HCV RNA at week 4 of therapy.

    Measured: Week 4 of therapy

  7. Decrease in Absolute Neutrophil Count (ANC) ≤0.75

    Measured: Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)

  8. Decrease in Platelets <50

    Measured: Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)

  9. Change in Hemoglobin at End of Treatment

    To evaluate indicators of toxicity during telaprevir based therapy

    Measured: Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)

  10. Resistance-associated Variants

    To examine the emergence of resistance-associated variants during telaprevir based therapy for early chronic infection

    Measured: Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)

  11. Baseline Resistance-associated Variants

    To correlate the presence and frequency of baseline resistance-associated variants (RAVs) with the response of Telaprevir based therapy for early chronic HCV infection.

    Measured: Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)

  12. Plasma Ribavirin Levels

    To correlate plasma ribavirin levels with treatment outcome and changes in haemoglobin during therapy

    Measured: Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)

  13. CD4 and HIV RNA

    In HIV positive participants to evaluate changes in CD4 counts and HIV RNA during telaprevir based therapy

    Measured: Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)

  14. Gene IL28B Polymorphism

    To examine treatment outcome by IL28B polymorphism

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Dec 2012 (estimated)
  2. Study startJan 2013
  3. Primary completionNov 2015
  4. Study completionJan 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01743521
Sponsor's protocol ID
VHCRP1102
Other IDs
VX-950HCP4010
Acronym
DARE-C
Status last verified
Feb 2017
First submitted
28 Nov 2012
Last updated
29 Mar 2017
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Martinello M, Hellard M, Shaw D, Petoumenos K, Applegate T, Grebely J, Yeung B, Maire L, Iser D, Lloyd A, Thompson A, Sasadeusz J, Haber P, Dore GJ, Matthews GV. Short duration response-guided treatment is effective for most individuals with recent hepatitis C infection: the ATAHC II and DARE-C I studies. Antivir Ther. 2016;21(5):425-34. doi: 10.3851/IMP3035. Epub 2016 Feb 11.

    PubMed 26867206

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing TPV/PEG-IFN/RBV in people with Hepatitis C, Chronic, run by Kirby Institute at 2 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SVR12 (Sustain Virological Response, HCV RNA Undetectable 12 Weeks Post-treatment) (time frame: 12 weeks post-treatment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01743521, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2017.

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