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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01384383




Registration number
NCT01384383
Ethics application status
Date submitted
22/06/2011
Date registered
29/06/2011
Date last updated
3/02/2014

Titles & IDs
Public title
GS-5885, GS-9451 With Peginterferon Alfa 2a (PEG) and Ribavirin in Treatment-Naïve Subjects With Chronic Genotype 1 Hep C Virus Infection and IL28B CC Genotype
Scientific title
A Phase 2 Randomized, Open-Label, Exploratory Trial of GS-5885, GS-9451 With Peginterferon Alfa 2a and Ribavirin (RBV) in Treatment-Naïve Subjects With Chronic Genotype 1 Hepatitis C Virus Infection and IL28B CC Genotype
Secondary ID [1] 0 0
GS-US-248-0121
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic 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 - GS-5885
Treatment: Drugs - GS-9451
Treatment: Drugs - RBV
Treatment: Drugs - PEG

Experimental: Arm 1 - Response-Guided Therapy with GS-5885 30 mg plus GS-9451 200 mg, plus PEG and RBV for 6 or 12 weeks.

Experimental: Arm 2 - Response-Guided Therapy with PEG and RBV for 24 weeks.


Treatment: Drugs: GS-5885
GS-5885 30 mg tablet administered orally once daily

Treatment: Drugs: GS-9451
GS-9451 200 mg tablet administered orally once daily

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

Treatment: Drugs: PEG
Pegylated interferon alfa-2a (PEG) 180 µg administered once weekly by subcutaneous injection

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

Outcomes
Primary outcome [1] 0 0
Sustained virologic response (SVR) - Sustained virologic response (SVR, defined as plasma HCV RNA < lower limit of quantification [LLoQ] at 24 weeks after treatment cessation) following treatment with GS-5885 + GS-9451 + PEG/RBV for 6 or 12 weeks, or PEG/RBV for 24 weeks in IL28B CC subjects.
Timepoint [1] 0 0
30 , 36 or 48 weeks
Secondary outcome [1] 0 0
Safety and tolerability of therapy - Safety and tolerability of the therapy is measured by frequency of laboratory abnormalities , reported adverse events and discontinuations due to adverse events.
Timepoint [1] 0 0
Up to 48 weeks
Secondary outcome [2] 0 0
Virologic response - Virologic response at Weeks 2, 4, 6, 8, 10, and 12 (depending on treatment arm) as measured by the rates of HCV RNA < LLoQ and viral breakthrough and relapse
Timepoint [2] 0 0
Weeks 2, 4, 6, 8, 10, and 12
Secondary outcome [3] 0 0
Compare SVR - Compare SVR following treatment with GS-5885 + GS-9451 + PEG/RBV for 6 weeks versus 12 weeks.
Timepoint [3] 0 0
Weeks 30 and 36
Secondary outcome [4] 0 0
Viral resistance - Characterize viral resistance to GS-5885 and GS-9451 when administered in combination with PEG/RBV
Timepoint [4] 0 0
Up to 96 Weeks

Eligibility
Key inclusion criteria
- Males and females 18-70 years of age

- Chronic HCV infection

- Subjects must have liver biopsy results (= 3 years prior to screening) indicating the
absence of cirrhosis. Alternatively a non-invasive alternative to liver biopsy (such
as FibroTest, FibroScan, or Acoustic Radiation Force Impulse imaging) within 6 months
of Screening in countries where allowed

- Monoinfection with HCV genotype 1a or 1b

- HCV RNA > 10^4 IU/mL at Screening

- IL28B CC genotype

- HCV treatment naïve

- Candidate for PEG/RBV therapy

- Body mass index (BMI) between 18 and 36 kg/m2

- Creatinine clearance >= 50 mL/min

- Agree to use two forms of highly effective contraception methods for the duration of
the study and for 7 months after the last dose study medication. Females of
childbearing potential must have negative pregnancy test at Screening and Baseline
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Exceed defined thresholds for key laboratory parameters at Screening

- Diagnosis of autoimmune disease, decompensated liver disease, poorly controlled
diabetes mellitus, significant psychiatric illness, severe chronic obstructive
pulmonary disease (COPD), HIV, hepatitis B virus (HBV), hepatocellular carcinoma or
other malignancy (with exception of certain skin cancers), hemoglobinopathy, retinal
disease, or are immunosuppressed

- Subjects with current use of amphetamines, cocaine, opiates (e.g., morphine, heroin),
or ongoing alcohol abuse are excluded. Subjects on stable methadone maintenance
treatment for at least 6 months prior to Screening may be included into the study

- Use of prohibited concomitant medications two weeks prior to baseline through the end
of treatment

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 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
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,WA
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Concord Repatriation General Hospital - Concord
Recruitment hospital [3] 0 0
Saint Vincents Hospital - Darlinghurst
Recruitment hospital [4] 0 0
Nepean Hospital - Kingswood
Recruitment hospital [5] 0 0
St. George Hospital - Kogarah
Recruitment hospital [6] 0 0
Liverpool Hospital - Sydney
Recruitment hospital [7] 0 0
Westmead Hospital - Westmead
Recruitment hospital [8] 0 0
Royal Brisbane Hospital Research Foundation - Herston
Recruitment hospital [9] 0 0
Greenslopes Private Hospital - Woolloongabba
Recruitment hospital [10] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [11] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [12] 0 0
St. Vincent's Hospital, Sydney Ltd. - Fitzroy
Recruitment hospital [13] 0 0
Western Hospital - Footscray
Recruitment hospital [14] 0 0
Austin Health, Department of Hepatology - Heidelberg
Recruitment hospital [15] 0 0
Alfred Hospital - Melbourne
Recruitment hospital [16] 0 0
Monash Medical Centre - Melbourne
Recruitment hospital [17] 0 0
Box Hill Hospital - Melbourne
Recruitment hospital [18] 0 0
Royal Melbourne Hospital - Parkville
Recruitment hospital [19] 0 0
Fremantle Hospital - Fremantle
Recruitment hospital [20] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2137 - Concord
Recruitment postcode(s) [3] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [4] 0 0
2747 - Kingswood
Recruitment postcode(s) [5] 0 0
NSW 2217 - Kogarah
Recruitment postcode(s) [6] 0 0
1871 - Sydney
Recruitment postcode(s) [7] 0 0
2145 - Westmead
Recruitment postcode(s) [8] 0 0
4029 - Herston
Recruitment postcode(s) [9] 0 0
4102 - Woolloongabba
Recruitment postcode(s) [10] 0 0
5042 - Bedford Park
Recruitment postcode(s) [11] 0 0
3065 - Fitzroy
Recruitment postcode(s) [12] 0 0
VIC 3011 - Footscray
Recruitment postcode(s) [13] 0 0
3081 - Heidelberg
Recruitment postcode(s) [14] 0 0
3004 - Melbourne
Recruitment postcode(s) [15] 0 0
3128 - Melbourne
Recruitment postcode(s) [16] 0 0
3050 - Parkville
Recruitment postcode(s) [17] 0 0
6160 - Fremantle
Recruitment postcode(s) [18] 0 0
6009 - Nedlands
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
Indiana
Country [4] 0 0
United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
Nevada
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Oregon
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
United States of America
State/province [10] 0 0
Utah
Country [11] 0 0
United States of America
State/province [11] 0 0
Virginia
Country [12] 0 0
United States of America
State/province [12] 0 0
Washington
Country [13] 0 0
Canada
State/province [13] 0 0
Alberta
Country [14] 0 0
Canada
State/province [14] 0 0
British Columbia
Country [15] 0 0
Canada
State/province [15] 0 0
Manitoba
Country [16] 0 0
Canada
State/province [16] 0 0
Ontario
Country [17] 0 0
New Zealand
State/province [17] 0 0
Aukland
Country [18] 0 0
New Zealand
State/province [18] 0 0
Hamilton

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

Ethics approval
Ethics application status

Summary
Brief summary
This is a Phase 2, randomized, open-label exploratory study that will examine the antiviral
efficacy, safety, and tolerability of Response guided treatment (RGT) with GS-5885 + GS-9451
+ PEG/RBV (6 or 12 weeks), or Peginterferon Alfa 2a (PEG)/Ribavirin (RBV)alone (24 weeks) in
treatment naïve subjects with chronic Hep C (HCV) infection with genotype (GT) 1 and IL28B CC
genotype.
Trial website
https://clinicaltrials.gov/show/NCT01384383
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/show/NCT01384383