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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/NCT01962441




Registration number
NCT01962441
Ethics application status
Date submitted
10/10/2013
Date registered
14/10/2013
Date last updated
20/06/2017

Titles & IDs
Public title
SOF (Sovaldi®) +RBV for 16 or 24 Weeks and SOF+RBV+Peg-IFN for 12 Weeks in Adults With Genotype 2 or 3 Chronic HCV Infection
Scientific title
A Phase 3B Randomized, Open-Label, Multi-Center Trial Assessing Sofosbuvir + Ribavirin for 16 or 24 Weeks and Sofosbuvir + Pegylated Interferon + Ribavirin for 12 Weeks in Subjects With Genotype 2 or 3 Chronic HCV Infection.
Secondary ID [1] 0 0
2013-002641-11
Secondary ID [2] 0 0
GS-US-334-0153
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 - SOF
Treatment: Drugs - RBV
Treatment: Drugs - Peg-IFN

Experimental: SOF+RBV 16 weeks - SOF+RBV for 16 weeks

Experimental: SOF+RBV 24 weeks - SOF+RBV for 24 weeks

Experimental: SOF+RBV+Peg-IFN 12 weeks - SOF+RBV+Peg-IFN for 12 weeks

Experimental: Retreatment Substudy - Participants from the SOF+RBV arms (16 weeks or 24 weeks) who experienced virologic failure on treatment, or during the posttreatment period at or before Posttreatment Week 24 may be eligible to enroll into the Retreatment Substudy to receive SOF+RBV+Peg-IFN for 12 weeks.


Treatment: Drugs: SOF
400 mg tablet administered orally once daily

Treatment: Drugs: RBV
Tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and = 75 kg = 1200 mg)

Treatment: Drugs: Peg-IFN
180 µg administered via subcutaneous injection once weekly
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
Timepoint [1] 0 0
Posttreatment Week 12
Primary outcome [2] 0 0
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Timepoint [2] 0 0
Up to 24 weeks
Secondary outcome [1] 0 0
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
Timepoint [1] 0 0
Posttreatment Weeks 4 and 24
Secondary outcome [2] 0 0
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24
Timepoint [2] 0 0
Weeks 1, 2, 4, 8, 12, 16, 20, and 24
Secondary outcome [3] 0 0
HCV RNA at Weeks 1, 2, 4, 8, and 12
Timepoint [3] 0 0
Weeks 1, 2, 4, 8, and 12
Secondary outcome [4] 0 0
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12
Timepoint [4] 0 0
Baseline; Weeks 1, 2, 4, 8, and 12
Secondary outcome [5] 0 0
Percentage of Participants Experiencing On-Treatment Virologic Failure
Timepoint [5] 0 0
Up to 24 weeks
Secondary outcome [6] 0 0
Percentage of Participants Experiencing Viral Relapse
Timepoint [6] 0 0
Up to Posttreatment Week 24

Eligibility
Key inclusion criteria
Key

- Male or female, age greater than or equal to 18 years.

- Confirmed chronic HCV infection.

- Subjects will have cirrhosis status assessment; liver biopsy may be required.

- Genotype 2 subjects must have cirrhosis of the liver to be eligible.

- Treatment-naive or prior treatment failure to =12 weeks of an interferon- based
regimen that was not discontinued prematurely due to an adverse event

- Infection with HCV genotype 2 or 3 as determined at Screening

- Body mass index (BMI) greater than or equal to 18 kg/m^2

- Screening laboratory values within predefined thresholds.

- Liver imaging (e.g., ultrasound) within 6 months of Baseline/Day 1 is required in
cirrhotic patients to exclude hepatocellular carcinoma (HCC). In the event of
intrahepatic lesions, triple phase CT scan or MRI should be performed to exclude HCC.

- Subject must be of generally good health as determined by the Investigator.

Key
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Prior use of any other inhibitor of the HCV nonstructural protein (NS)5B polymerase

- Pregnant or nursing female or male with pregnant female partner

- History of any other clinically significant chronic liver disease.

- HIV or chronic hepatitis B virus (HBV) infection.

- Malignancy with the exception of certain resolved skin cancers.

- Chronic use of systemically administered immunosuppressive agents.

- Clinically-relevant drug or alcohol abuse.

- History of solid organ transplantation.

- Current or prior history of clinical hepatic decompensation.

- History of clinically-significant illness or any other major medical disorder that may
interfere with subject treatment, assessment or compliance with the protocol.

- Known hypersensitivity to interferon, RBV, the study investigational medicinal
product, the metabolites, or formulation excipients.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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
24/09/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
7/07/2016
Sample size
Target
Accrual to date
Final
601
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
- Camperdown
Recruitment hospital [2] 0 0
- Kogarah
Recruitment hospital [3] 0 0
- Westmead
Recruitment hospital [4] 0 0
- Brisbane
Recruitment hospital [5] 0 0
- Greenslopes
Recruitment hospital [6] 0 0
- Woolloongabba
Recruitment hospital [7] 0 0
- Adelaide
Recruitment hospital [8] 0 0
- Clayton
Recruitment hospital [9] 0 0
- Fitzroy
Recruitment hospital [10] 0 0
- Heidelberg
Recruitment hospital [11] 0 0
- Melbourne
Recruitment hospital [12] 0 0
- Nedlands Perth
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2217 - Kogarah
Recruitment postcode(s) [3] 0 0
2145 - Westmead
Recruitment postcode(s) [4] 0 0
4029 - Brisbane
Recruitment postcode(s) [5] 0 0
4120 - Greenslopes
Recruitment postcode(s) [6] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [7] 0 0
5000 - Adelaide
Recruitment postcode(s) [8] 0 0
3168 - Clayton
Recruitment postcode(s) [9] 0 0
3065 - Fitzroy
Recruitment postcode(s) [10] 0 0
3084 - Heidelberg
Recruitment postcode(s) [11] 0 0
3004 - Melbourne
Recruitment postcode(s) [12] 0 0
6009 - Nedlands Perth
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
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Louisiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Massachusetts
Country [7] 0 0
United States of America
State/province [7] 0 0
Michigan
Country [8] 0 0
United States of America
State/province [8] 0 0
Minnesota
Country [9] 0 0
United States of America
State/province [9] 0 0
New Jersey
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
Tennessee
Country [12] 0 0
United States of America
State/province [12] 0 0
Texas
Country [13] 0 0
United States of America
State/province [13] 0 0
Virginia
Country [14] 0 0
United States of America
State/province [14] 0 0
Washington
Country [15] 0 0
Canada
State/province [15] 0 0
Alberta
Country [16] 0 0
Canada
State/province [16] 0 0
British Columbia
Country [17] 0 0
Canada
State/province [17] 0 0
Manitoba
Country [18] 0 0
Canada
State/province [18] 0 0
Ontario
Country [19] 0 0
Canada
State/province [19] 0 0
Quebec
Country [20] 0 0
New Zealand
State/province [20] 0 0
Auckland
Country [21] 0 0
New Zealand
State/province [21] 0 0
Chatham Islands
Country [22] 0 0
New Zealand
State/province [22] 0 0
Waikato
Country [23] 0 0
New Zealand
State/province [23] 0 0
Wellington
Country [24] 0 0
United Kingdom
State/province [24] 0 0
Birmingham
Country [25] 0 0
United Kingdom
State/province [25] 0 0
Cambridgeshire
Country [26] 0 0
United Kingdom
State/province [26] 0 0
LN
Country [27] 0 0
United Kingdom
State/province [27] 0 0
Bradford
Country [28] 0 0
United Kingdom
State/province [28] 0 0
Dundee
Country [29] 0 0
United Kingdom
State/province [29] 0 0
Edinburgh
Country [30] 0 0
United Kingdom
State/province [30] 0 0
Frimley
Country [31] 0 0
United Kingdom
State/province [31] 0 0
Glasgow
Country [32] 0 0
United Kingdom
State/province [32] 0 0
Leeds
Country [33] 0 0
United Kingdom
State/province [33] 0 0
Liverpool
Country [34] 0 0
United Kingdom
State/province [34] 0 0
London
Country [35] 0 0
United Kingdom
State/province [35] 0 0
Manchester
Country [36] 0 0
United Kingdom
State/province [36] 0 0
Newcastle Upon Tyne
Country [37] 0 0
United Kingdom
State/province [37] 0 0
Nottingham
Country [38] 0 0
United Kingdom
State/province [38] 0 0
Oxford
Country [39] 0 0
United Kingdom
State/province [39] 0 0
Plymouth
Country [40] 0 0
United Kingdom
State/province [40] 0 0
Portsmouth
Country [41] 0 0
United Kingdom
State/province [41] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Gilead Sciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will assess the efficacy, safety, and tolerability of 16 or 24 weeks of sofosbuvir
(Sovaldi®; SOF) + ribavirin (RBV), and 12 weeks of SOF+RBV+ pegylated interferon (Peg-IFN) in
treatment-naive and treatment-experienced adults with chronic genotype 3 hepatitis C virus
(HCV) infection, and treatment-experienced adults with cirrhosis and chronic genotype 2 HCV
infection.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01962441
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gilead Study Director
Address 0 0
Gilead Sciences
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