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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02716428




Registration number
NCT02716428
Ethics application status
Date submitted
9/03/2016
Date registered
23/03/2016
Date last updated
17/10/2017

Titles & IDs
Public title
A Study of Faldaprevir, TD-6450 and Other Antivirals in Participants With Genotype 1b Hepatitis C Virus Infection
Scientific title
A Phase 2, Open-Label Study to Investigate the Safety and Efficacy of Faldaprevir and TD 6450 Alone and in Combination With Other Antivirals for 12 Weeks in Treatment-Naive Patients Chronically Infected With Genotype 1 Hepatitis C Virus
Secondary ID [1] 0 0
TRK-450-0203
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis C Viral Infection 0 0
Chronic Hepatitis C 0 0
Hepatitis C (HCV) 0 0
Hepatitis C Genotype 1 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
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 - Faldaprevir
Treatment: Drugs - TD-6450
Treatment: Drugs - Ribavirin

Experimental: Cohort 1 - 12 weeks of Faldaprevir plus TD-6450 plus Ribavirin

Experimental: Cohort 2 - 12 weeks of Faldaprevir plus TD-6450


Treatment: Drugs: Faldaprevir


Treatment: Drugs: TD-6450


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

Outcomes
Primary outcome [1] 0 0
Percentage of subjects achieving 12-week sustained virologic response following treatment with 2 direct acting anti-virals with and without ribavirin in Genotype 1b Hepatitis C infected adults
Timepoint [1] 0 0
Post Treatment Week 12
Secondary outcome [1] 0 0
Percentage of subjects with virologic response 2, 4 and 8 weeks after treatment completion (HCV RNA less than lower limit of quantitation at 2, 4 and 8 weeks after end of therapy with Faldaprevir plus TD-6450 with and without ribavirin)
Timepoint [1] 0 0
Post Treatment Weeks 2 to 8
Secondary outcome [2] 0 0
Safety as determined by the incidence of serious adverse events, Grade 3 or 4 adverse events and laboratory abnormalities, and discontinuations due to adverse events
Timepoint [2] 0 0
Randomization through End of Study, up to 24 weeks

Eligibility
Key inclusion criteria
- Chronic genotype 1b hepatitis C infection and HCV RNA = 10^4 IU/mL at screening

- Hepatitis C virus treatment naive, defined as defined as having never received a
direct acting anti-viral (DAA), and as having received = 8 weeks of interferon = 6
months prior to screening

- Absence of cirrhosis as defined by one of the following:

- A liver biopsy performed within 24 calendar months of Day 1 showing absence of
cirrhosis

- Transient elastography (FibroScan®) performed within 12 calendar months of Day 1
with a result of = 12.5 kPa (kilopascals)

- A non-invasive test measuring liver scarring (FibroSure®) score = 0.48 and AST
(aspartate aminotransferase):platelet ratio (APRI) = 1 performed during screening
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Infection with hepatitis B virus (HBV) or human immunodeficiency virus, HIV-1 or HIV-2

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
Single group
Other design features
Phase
Phase 2
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
1/05/2016
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2017
Sample size
Target
Accrual to date
Final
25
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Tennessee
Country [4] 0 0
New Zealand
State/province [4] 0 0
Auckland
Country [5] 0 0
New Zealand
State/province [5] 0 0
Dunedin
Country [6] 0 0
New Zealand
State/province [6] 0 0
Waikato

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Trek Therapeutics, PBC
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Phase 2 study designed to assess the safety, efficacy, and pharmacokinetics of Faldaprevir
and TD-6450 alone or in combination with other antivirals for a 12-week treatment duration in
treatment-naïve participants with genotype 1b hepatitis C virus (HCV) infection.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02716428
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ed Gane, MD
Address 0 0
Auckland Clinical Studies Ltd
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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02716428