Trial Review

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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/NCT01842451




Registration number
NCT01842451
Ethics application status
Date submitted
24/04/2013
Date registered
29/04/2013
Date last updated
29/12/2015

Titles & IDs
Public title
A Phase 2 Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-135 and Daclatasvir in Subjects With Genotype 1 Chronic Hepatitis C Chronic Hepatitis C
Scientific title
A Phase 2, Multicenter, Randomized, Partially-Blind, Dose-Ranging Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-135 and Daclatasvir in Treatment-Naïve Adult Subjects With Genotype 1 Chronic Hepatitis C
Secondary ID [1] 0 0
VX13-135-105
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis C 0 0
CHC 0 0
HCV 0 0
Hepatitis C 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 - VX-135
Treatment: Drugs - Daclatasvir

Experimental: VX-135 High Dose with Daclatasvir - 12 weeks of a high dose of VX-135 in combination with Daclatasvir

Experimental: VX-135 Low Dose with Daclatasvir - 12 weeks of a low dose of VX-135 in combination with Daclatasvir


Treatment: Drugs: VX-135


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

Outcomes
Primary outcome [1] 0 0
The safety and tolerability as assessed by adverse events (AEs), vital signs, 12-lead electrocardiograms (ECGs), echocardiograms, and laboratory assessments
Timepoint [1] 0 0
Up to 64 weeks
Secondary outcome [1] 0 0
The proportion of subjects who have a sustained virologic response (SVR; i.e., HCV RNA concentration below the lower limit of quantitation [<LLOQ; <25 IU/mL]) at 4 weeks after the last planned dose of treatment (SVR4)
Timepoint [1] 0 0
Up to 20 Weeks
Secondary outcome [2] 0 0
The proportion of subjects who have an SVR at 12 weeks after the last planned dose of treatment (SVR12)
Timepoint [2] 0 0
Up to 28 weeks
Secondary outcome [3] 0 0
The proportion of subjects who have an SVR at 44 weeks after the last planned dose of treatment (SVR24)
Timepoint [3] 0 0
Up to 40 weeks
Secondary outcome [4] 0 0
The proportion of subjects who have virologic relapse
Timepoint [4] 0 0
Up to 64 weeks
Secondary outcome [5] 0 0
The proportion of subjects who have virologic breakthrough
Timepoint [5] 0 0
Up to 16 weeks
Secondary outcome [6] 0 0
The amino acid sequence of the nonstructural NS5A and NS5B proteins in subjects who have treatment failure
Timepoint [6] 0 0
Up to 64 weeks
Secondary outcome [7] 0 0
The proportion of subjects who achieve SVR12 by HCV genotype 1 subtype (1a versus non-1a)
Timepoint [7] 0 0
Up to 28 weeks
Secondary outcome [8] 0 0
The proportion of subjects who achieve SVR12 by IL-28B genotype (CC versus non-CC)
Timepoint [8] 0 0
Up to 28 weeks

Eligibility
Key inclusion criteria
- Subjects must have genotype 1 CHC and evidence of HCV infection at least 6 months
before screening

- Subjects must be treatment-naïve and have not received prior treatment with any
interferon, immunomodulatory agent, or DAA for HCV
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Evidence of cirrhosis

- History or other clinical evidence of significant or unstable cardiac disease

- Any other cause of significant liver disease in addition to hepatitis C

- Creatinine clearance =50 mL/min using the Cockcroft-Gault equation at screening

- Female subjects who are pregnant or nursing

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
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
1/06/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2014
Sample size
Target
Accrual to date
Final
23
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland
Country [2] 0 0
New Zealand
State/province [2] 0 0
Christchurch

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Vertex Pharmaceuticals Incorporated
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
A Phase 2 Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of
VX-135 and Daclatasvir in Treatment-Naïve Adult Subjects With Genotype 1 Chronic Hepatitis C
Trial website
https://clinicaltrials.gov/ct2/show/NCT01842451
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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/NCT01842451