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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01743521




Registration number
NCT01743521
Ethics application status
Date submitted
28/11/2012
Date registered
6/12/2012
Date last updated
29/03/2017

Titles & IDs
Public title
DAA Based Therapy for Recently Acquired Hepatitis C (DARE-C)
Scientific title
Direct Acting Antiviral (DAA) Based Therapy for Recently Acquired Hepatitis C
Secondary ID [1] 0 0
VX-950HCP4010
Secondary ID [2] 0 0
VHCRP1102
Universal Trial Number (UTN)
Trial acronym
DARE-C
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C, Chronic 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - TPV/PEG-IFN/RBV

Experimental: Group A - 8 weeks total therapy - 8 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 2 weeks of therapy

Experimental: Group B - 12 weeks total therapy - 12 weeks total therapy of TPV/PEG-IFN/RBV if undetectable HCV RNA after 4 weeks of therapy

Experimental: Group C - 24 weeks total therapy - 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


Treatment: Drugs: 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.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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)
Timepoint [1] 0 0
12 weeks post-treatment
Secondary outcome [1] 0 0
SVR24 - To evaluate the proportion of patients with undetectable HCV RNA 24 weeks after therapy completion (SVR24)
Timepoint [1] 0 0
24 weeks post-treatment
Secondary outcome [2] 0 0
Undetectable HCV RNA (ETR) - To evaluate the proportion of patients with undetectable HCV RNA at end of treatment (ETR)
Timepoint [2] 0 0
Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)
Secondary outcome [3] 0 0
Undetectable HCV RNA (Week 1) - To evaluate the proportion of patients with undetectable HCV RNA at week 1 of therapy.
Timepoint [3] 0 0
Week 1 of therapy
Secondary outcome [4] 0 0
Undectectable HCV RNA (Week 2) - To evaluate the proportion of patients with undetectable HCV RNA at week 1 of therapy.
Timepoint [4] 0 0
Week 2 of therapy
Secondary outcome [5] 0 0
Undetectable HCV RNA (Week 3) - To evaluate the proportion of patients with undetectable HCV RNA at week 3 of therapy.
Timepoint [5] 0 0
Week 3 of therapy
Secondary outcome [6] 0 0
Undetectable HCV RNA (Week 4) - To evaluate the proportion of patients with undetectable HCV RNA at week 4 of therapy.
Timepoint [6] 0 0
Week 4 of therapy
Secondary outcome [7] 0 0
Decrease in Absolute Neutrophil Count (ANC) =0.75
Timepoint [7] 0 0
Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)
Secondary outcome [8] 0 0
Decrease in Platelets <50
Timepoint [8] 0 0
Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)
Secondary outcome [9] 0 0
Change in Hemoglobin at End of Treatment - To evaluate indicators of toxicity during telaprevir based therapy
Timepoint [9] 0 0
Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)
Secondary outcome [10] 0 0
Resistance-associated Variants - To examine the emergence of resistance-associated variants during telaprevir based therapy for early chronic infection
Timepoint [10] 0 0
Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)
Secondary outcome [11] 0 0
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.
Timepoint [11] 0 0
Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)
Secondary outcome [12] 0 0
Plasma Ribavirin Levels - To correlate plasma ribavirin levels with treatment outcome and changes in haemoglobin during therapy
Timepoint [12] 0 0
Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)
Secondary outcome [13] 0 0
CD4 and HIV RNA - In HIV positive participants to evaluate changes in CD4 counts and HIV RNA during telaprevir based therapy
Timepoint [13] 0 0
Baseline, Wk 8 (Group A), Wk 12 (Group B), Wk 24 (Group C)
Secondary outcome [14] 0 0
Gene IL28B Polymorphism - To examine treatment outcome by IL28B polymorphism
Timepoint [14] 0 0
Baseline

Eligibility
Key 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 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
Minimum age
18 Years
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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 Pegylated-interferon (PEG-IFN), Ribavirin (RBV) and Telaprevir
(TPV) therapy

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA
Recruitment hospital [1] 0 0
St Vincent's Hospital - Sydney
Recruitment hospital [2] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 0 0
2010 - Sydney
Recruitment postcode(s) [2] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Other
Name
Kirby Institute
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Janssen-Cilag Ltd.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/show/NCT01743521
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gail Matthews, MbChB, PhD
Address 0 0
Kirby Institute
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications