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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/NCT01260350
Registration number
NCT01260350
Ethics application status
Date submitted
13/12/2010
Date registered
15/12/2010
Date last updated
17/11/2014
Titles & IDs
Public title
Open-Labeled Study of PSI-7977 and RBV With and Without PEG-IFN in Treatment-Naïve Patients With HCV GT2 or GT3
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Scientific title
A Multi-center, Open-Labeled Exploratory Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Oral Administration of PSI-7977 400 mg and Ribavirin for 12 Weeks With and Without Pegylated Interferon in Treatment-Naïve Patients With Chronic HCV Infection Genotype 2 or Genotype 3
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Secondary ID [1]
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Medsafe
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Secondary ID [2]
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P7977-0523
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis C Infection
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Condition category
Condition code
Infection
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Studies of infection and infectious agents
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Infection
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Other infectious diseases
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Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - SOF
Treatment: Drugs - RBV
Treatment: Drugs - PEG
Treatment: Drugs - LDV
Treatment: Drugs - GS-9669
Treatment: Drugs - LDV/SOF
Experimental: Group 1: SOF+RBV 12 wk: GT 2 or 3, TN - Treatment-naive (TN) participants with genotype (GT) 2 or 3 HCV infection will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks.
Experimental: Group 2: SOF+RBV 12 wk+PEG 4 wk: GT 2 or 3, TN - Treatment-naive participants with genotype 2 or 3 HCV infection will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 4 weeks.
Experimental: Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TN - Treatment-naive participants with genotype 2 or 3 HCV infection will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks plus PEG 180 µg once weekly for 8 weeks.
Experimental: Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TN - Treatment-naive participants with genotype 2 or 3 HCV infection will receive SOF 400 mg once daily+weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 12 weeks.
Experimental: Group 5: SOF 12 wk: GT 2 or 3, TN - Treatment-naive participants with genotype 2 or 3 HCV infection will receive SOF 400 mg once daily for 12 weeks.
Experimental: Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TN - Treatment-naive participants with genotype 2 or 3 HCV infection will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus PEG 180 µg once weekly for 8 weeks.
Experimental: Group 7: SOF+RBV 12 wk: GT 1, TE - Treatment-experienced (TE) participants with genotype 1 HCV infection who did not respond to prior treatment will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks.
Experimental: Group 8: SOF+RBV 12 wk: GT 1, TN - Treatment-naive participants with genotype 1 HCV infection will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks.
Experimental: Group 9: SOF+RBV 12 wk: GT 2 or 3, TE - Treatment-experienced participants with genotype 2 or 3 HCV infection will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks.
Experimental: Group 10: SOF+RBV 8 wk: GT 2 or 3, TN - Treatment-naive participants with genotype 2 or 3 HCV infection will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 8 weeks.
Experimental: Group 11: SOF+RBV 12 wk: GT 2 or 3, TN - Treatment-naive participants with genotype 2 or 3 HCV infection will receive SOF 400 mg once daily plus split-dose RBV (800 mg in a divided daily dose) for 12 weeks.
Experimental: Group 12: SOF+RBV+LDV 12 wk: GT 1, TE - Treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks.
Experimental: Group 13: SOF+RBV+LDV 12 wk: GT 1, TN - Treatment-naive participants with genotype 1 HCV infection will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus LDV 90 mg once daily for 12 weeks.
Experimental: Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TE - Treatment-experienced participants with genotype 1 HCV infection who did not respond to prior treatment will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks.
Experimental: Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TN - Treatment-naive participants with genotype 1 HCV infection will receive SOF 400 mg once daily plus weight-based RBV (1000-1200 in a divided daily dose) plus GS-9669 500 mg once daily for 12 weeks.
Experimental: Group 16: LDV/SOF FDC 12 wk: GT 1, fibrosis - Treatment-experienced participants with genotype 1 HCV infection and Stage F4 fibrosis who did not respond to prior treatment will receive LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks.
Experimental: Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, fibrosis - Treatment-experienced participants with genotype 1 HCV infection with Stage F4 fibrosis who did not respond to prior treatment will receive LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks.
Experimental: Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TN - Treatment-naive participants with genotype 2 or 3 HCV infection will receive LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks.
Experimental: Group 19: LDV/SOF FDC 12 wk: GT 2 or 3, TE - Treatment-experienced participants with genotype 2 or 3 HCV infection will receive LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks.
Experimental: Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, hemophiliac - Hemophiliac participants with genotype 1 HCV infection will receive LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 12 weeks.
Experimental: Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TN - Treatment-naive participants with genotype 1 HCV infection will receive LDV 90 mg/SOF 400 mg FDC once daily plus weight-based RBV (1000-1200 in a divided daily dose) for 6 weeks.
Experimental: Group 22: LDV/SOF FDC 6 wk: GT 1, TN - Treatment-naive participants with genotype 1 HCV infection were randomized to receive LDV 90 mg/SOF 400 mg FDC once daily for 6 weeks.
Treatment: Drugs: SOF
Sofosbuvir (SOF) tablets administered orally once daily
Treatment: Drugs: RBV
Ribavirin (RBV) capsules administered orally in a divided daily dose
Treatment: Drugs: PEG
Peginterferon alfa-2a (PEG) administered via subcutaneous injection once weekly
Treatment: Drugs: LDV
Ledipasvir (LDV) tablets administered orally once daily
Treatment: Drugs: GS-9669
GS-9669 tablets administered orally once daily
Treatment: Drugs: LDV/SOF
LDV/SOF fixed-dose combination (FDC) tablet administered once daily
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants Who Experienced Adverse Events
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Assessment method [1]
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Adverse events (AEs) occurring from baseline (Day 1 for all groups) to 30 days following the last dose of study drug were summarized across the participant population. A participant was counted once if they had a qualifying event.
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Timepoint [1]
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Up to 12 weeks plus 30 days
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Secondary outcome [1]
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Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12)
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Assessment method [1]
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SVR12 was defined as HCV RNA < the limit of detection (LOD; < 15 IU/mL) 12 weeks after the last dose of study drug.
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Timepoint [1]
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Posttreatment Week 12
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Secondary outcome [2]
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Percentage of Participants With HCV RNA < LOD at Week 6
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Assessment method [2]
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Timepoint [2]
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Week 6
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Secondary outcome [3]
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Percentage of Participants With HCV RNA < LOD at Week 8
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Assessment method [3]
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Data are not presented for Group 21 which ended treatment after Week 6.
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Timepoint [3]
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Week 8
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Secondary outcome [4]
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Percentage of Participants With HCV RNA < LOD at Week 12
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Assessment method [4]
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Data are not presented for Groups 6, 10, and 21 which ended treatment after Week 8 or Week 6.
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Timepoint [4]
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Week 12
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Secondary outcome [5]
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Change From Baseline in HCV RNA at Week 6
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Assessment method [5]
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Timepoint [5]
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Baseline to Week 6
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Secondary outcome [6]
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Change From Baseline in HCV RNA at Week 8
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Assessment method [6]
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Data are not presented for Group 21 which ended treatment after Week 6.
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Timepoint [6]
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Baseline to Week 8
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Secondary outcome [7]
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Change From Baseline in HCV RNA at Week 12
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Assessment method [7]
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Data are not presented for Groups 6, 10, and 21 which ended treatment after Week 8 or Week 6. Data are not presented for Groups 16, 17, 18, and 20 because participants with detectable HCV RNA discontinued due to protocol-specified stopping rules.
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Timepoint [7]
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Baseline to Week 12
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Secondary outcome [8]
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Percentage of Participants With Virologic Failure
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Assessment method [8]
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The percentage of participants with on-treatment virologic failure (viral breakthrough, rebound, or nonresponse) or following treatment (viral relapse) was summarized.
On-treatment virologic failure was defined as:
Viral breakthrough (confirmed HCV RNA = LOD after having previously had HCV RNA < LOD while on treatment),
Viral rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, or
Nonresponse (HCV RNA persistently = LOD through 6 weeks of treatment)
Viral relapse was defined as confirmed HCV RNA = LOD during the posttreatment period having achieved HCV RNA < LOD at the last on-treatment visit.
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Timepoint [8]
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Up to Posttreatment Week 24
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Eligibility
Key inclusion criteria
- Chronic Genotype 2 or 3 HCV-infection or Genotype 1, serum HCV RNA = 50,000 IU/mL
- Not co-infected with HIV
- Use of highly effective contraception methods if female of childbearing potential or
sexually active male
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- History of any other clinically significant chronic liver disease
- Pregnant or nursing female or male with pregnant female partner
- History of significant drug allergy to nucleoside/nucleotide analogs.
- Participation in a clinical study within 3 months prior to first dose
- Positive result for significant drug use at Screening
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/12/2010
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/12/2013
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Sample size
Target
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Accrual to date
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Final
292
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Auckland
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Country [2]
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New Zealand
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State/province [2]
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Christchurch
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Gilead Sciences
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This study is to assess the safety and tolerability of sofosbuvir (SOF) 400 mg with and
without ribavirin (RBV) and/or with and without pegylated interferon alfa-2a (PEG) in
subjects with genotype 1, 2 or 3 hepatitis C (HCV) infection.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01260350
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Robert H. Hyland, DPhil
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Address
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Gilead Sciences
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01260350
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