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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT01743521
Ethics application status
Date submitted
28/11/2012
Date registered
6/12/2012

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)
Timepoint [1] 0 0
12 weeks post-treatment
Secondary outcome [1] 0 0
SVR24
Timepoint [1] 0 0
24 weeks post-treatment
Secondary outcome [2] 0 0
Undetectable HCV RNA (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)
Timepoint [3] 0 0
Week 1 of therapy
Secondary outcome [4] 0 0
Undectectable HCV RNA (Week 2)
Timepoint [4] 0 0
Week 2 of therapy
Secondary outcome [5] 0 0
Undetectable HCV RNA (Week 3)
Timepoint [5] 0 0
Week 3 of therapy
Secondary outcome [6] 0 0
Undetectable HCV RNA (Week 4)
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
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
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
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
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
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
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
Sex
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
1/01/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2016
Sample size
Target
Accrual to date
Final
14
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
Government body
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
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results are available at https://clinicaltrials.gov/study/NCT01743521