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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02319031




Registration number
NCT02319031
Ethics application status
Date submitted
12/12/2014
Date registered
18/12/2014
Date last updated
27/01/2017

Titles & IDs
Public title
Safety and Efficacy Study of the Combination Daclatasvir (60 mg), Sofosbuvir (400 mg) and Ribavirin (Weight-based Dosing) for 12 or 16 Weeks in Subjects With Genotype 3 Chronic HCV Infection With or Without Prior Treatment Experience and Advanced Fibrosis or Compensated Cirrhosis
Scientific title
Open-Label, Randomized Study of Daclatasvir, Sofosbuvir, and Ribavirin for 12 vs. 16 Weeks in Treatment Naive and Treatment Experienced Patients With Genotype 3 Chronic Hepatitis C Infection Subjects With Compensated Advanced Fibrosis/Cirrhosis (F3/F4)
Secondary ID [1] 0 0
AI444-326
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
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 - Daclatasvir
Treatment: Drugs - Sofosbuvir
Treatment: Drugs - Ribavirin

Active Comparator: Arm1: Daclatasvir + Sofosbuvir + Ribavirin (12 Weeks) - Oral dosing Daclatasvir 60mg once daily, Sofosbuvir 400mg once daily, and Ribavirin 1000-1200mg (weight based dosing) split into am and pm dosing

Active Comparator: Arm2 : Daclatasvir + Sofosbuvir + Ribavirin (16 Weeks) - Oral dosing Daclatasvir 60mg once daily, Sofosbuvir 400mg once daily, and Ribavirin 1000-1200mg (weight based dosing) split into am and pm dosing


Treatment: Drugs: Daclatasvir


Treatment: Drugs: Sofosbuvir


Treatment: Drugs: Ribavirin


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

Outcomes
Primary outcome [1] 0 0
Percent of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 12 (SVR12) - SVR12, defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantitation (LLOQ), target detected (TD) or target not detected (TND) at follow-up Week 12. SVR12 imputation was based on Next Value Carried Backwards (NVCB) approach. HCV RNA measurements were excluded after the start of non-study anti-HCV medication on treatment or during follow-up.
Timepoint [1] 0 0
Follow-up Week 12
Secondary outcome [1] 0 0
Percent of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 4 (SVR4) and Follow-up Week 24 (SVR24) - SVR4, defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantitation (LLOQ), target detected (TD) or target not detected (TND) at follow-up Week 4. SVR24, defined as percentage of participants with hepatitis C virus (HCV) ribonucleic acid (RNA) < lower limit of quantitation (LLOQ), target detected (TD) or target not detected (TND) at follow-up Week 24. SVR4 imputation was based on Next Value Carried Backwards (NVCB) approach. SVR24 imputation was based on missing being treated as non-responder. HCV RNA measurements were excluded after the start of non-study anti-HCV medication on treatment or during follow-up.
Timepoint [1] 0 0
Follow-up Weeks 4 and 24
Secondary outcome [2] 0 0
Number of Participants With Death, Serious Adverse Events (SAEs), Discontinuation Due to Adverse Events (AEs), Grade 3 or Grade 4 (Grade 3/4) AEs, and Grade 3/4 Laboratory Abnormalities - Serious adverse event (SAE) defined: a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Adverse event (AE) defined: any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. The degree of the adverse event or laboratory abnormality are evaluated by grades: Grade (Gr) 1=Mild, Gr 2=Moderate, Gr 3=Severe, Gr 4=Life-threatening or disabling, Gr 5=Death. Grading as per using National Cancer Institute Common Terminology Criteria (NCI CTC) Version 3.0 criteria.
Timepoint [2] 0 0
Date of First Dose of Study Drug to 7 Days post last dose of study drug (up to 13 weeks or 17 weeks depending on the randomized treatment group)

Eligibility
Key inclusion criteria
For more information regarding BMS clinical trial participation, please visit
www.BMSStudyConnect.com



- Must have Genotype 3 Chronic HCV

- Must have advanced fibrosis (F3) or compensated cirrhosis (F4)

- HCV RNA Viral load = 10,000 IU/mL

- HCV Treatment naive or treatment-experienced
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Non Genotype 3 or mixed genotypes

- Non advanced fibrosis or compensated cirrhosis

- Any prior treatment with NS5A inhibitors

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
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,QLD,SA,VIC
Recruitment hospital [1] 0 0
Local Institution - Darlinghurst
Recruitment hospital [2] 0 0
Local Institution - Greenslopes
Recruitment hospital [3] 0 0
Local Institution - Adelaide
Recruitment hospital [4] 0 0
Local Institution - Clayton
Recruitment hospital [5] 0 0
Local Institution - Fitzroy
Recruitment hospital [6] 0 0
Local Institution - Heidelberg
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
4120 - Greenslopes
Recruitment postcode(s) [3] 0 0
5000 - Adelaide
Recruitment postcode(s) [4] 0 0
3168 - Clayton
Recruitment postcode(s) [5] 0 0
3065 - Fitzroy
Recruitment postcode(s) [6] 0 0
3084 - Heidelberg
Recruitment outside Australia
Country [1] 0 0
France
State/province [1] 0 0
Creteil Cedex
Country [2] 0 0
France
State/province [2] 0 0
Grenoble Cedex 09
Country [3] 0 0
France
State/province [3] 0 0
Paris Cedex 14
Country [4] 0 0
France
State/province [4] 0 0
Vandoeuvre Les Nancy

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of the study is to determine if the combination of Daclatasvir, Sofosbuvir and
Ribavirin for 12 or 16 weeks is safe and effective in the treatment of Genotype 3 Chronic
Hepatitis C (HCV) in patients with advanced fibrosis or compensated cirrhosis. Patients in
this study may have already been treated prior for HCV or may have never received treatment
for their HCV.
Trial website
https://clinicaltrials.gov/show/NCT02319031
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol - Myers Squibb
Address 0 0
Bristol-Myers Squibb
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