AzTrials
AzTrials

Chronic Hepatitis C InfectionPhase 2NCT01260350

Open-Labeled Study of PSI-7977 and RBV With and Without PEG-IFN in Treatment-Naïve Patients With HCV GT2 or GT3

A Phase 2 study testing SOF, RBV and PEG in people with Chronic Hepatitis C Infection, run by Gilead Sciences at 2 sites in New Zealand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Hepatitis C Infection
What is being tested?
SOF, RBV and PEG
Could I receive a placebo?
No, everyone receives an active treatment
How many people
292 participants
Where
2 sitesNew Zealand
Study dates
Dec 2010to Dec 2013
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

New Zealand2 sites

  • Auckland Clinical Studies Ltd.

    Auckland

  • Christchurch Clinical Studies Trust

    Christchurch

Other trials in New Zealand

About this study

Official 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

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.

Read the detailed description

Part 1: HCV genotype 2 or 3: participants will receive SOF 400 mg once daily with weight-based RBV for 12 weeks. Participants will be randomized in equal proportions to: no PEG (Arm 1), PEG for 4 weeks (Arm 2), PEG for 8 weeks (Arm 3), or PEG for 12 weeks (Arm 4).

Part 2: HCV genotype 2 or 3: participants will receive SOF 400 mg once daily (monotherapy) for 12 weeks (Arm 5), or SOF 400 mg once daily with PEG and weight-based RBV for 8 weeks (Arm 6); HCV genotype 1: null responders (did not respond to their prior treatment) will receive SOF 400 mg once daily with weight-based RBV for 12 weeks (Arm 7).

Part 3: HCV genotype 1 treatment-naive (Arm 8) or HCV genotype 2 or 3 treatment-experienced participants (Arm 9) will receive SOF 400 mg once daily in combination with weight-based RBV for 12 weeks.

Part 4: HCV genotype 2 or 3 treatment naive participants will receive SOF 400 mg once daily with weight-based RBV for 8 weeks (Arm 10) or SOF 400 mg once daily and 800 mg RBV for 12 weeks (Arm 11). HCV genotype 1 null responders will receive SOF 400 mg once daily, ledipasvir (LDV), and weight based RBV for 12 weeks (Arm 12). HCV genotype-1 treatment naive participants will receive SOF 400 mg once daily with weight-based RBV and LDV for 12 weeks (Arm 13).

Part 5: HCV genotype 1 null responders will receive SOF 400 mg once daily with GS-9669 500 mg once daily and weight-based RBV for 12 weeks (Arm 14). HCV genotype-1 treatment naive participants receive SOF 400 mg once daily with GS-9669 500 mg once daily and weight-based RBV for 12 weeks (Arm 15).

Part 6: HCV genotype 1 null responders with Stage F4 fibrosis will receive LDV/SOF FDC for 12 weeks (Arm 16) or LDV/SOF FDC with weight-based RBV for 12 weeks (Arm 17). HCV genotype 2 or 3 treatment-naive participants will receive LDV/SOF FDC for 12 weeks (Arm 18). HCV genotype 2 or 3 treatment-experienced participants will receive LDV/SOF FDC for 12 weeks (Arm 19). HCV genotype 1 hemophiliacs will receive LDV/SOF FDC with weight-based RBV for 12 weeks (Arm 20). HCV genotype 1 treatment-naive participants will receive LDV/SOF FDC with weight-based RBV for 6 weeks (Arm 21). HCV genotype 1 treatment-naive participants will receive LDV/SOF FDC for 6 weeks (Arm 22).

Being tested
SOF, RBV, PEG, LDV, GS-9669
Keywords
PSI-7977, Sofosbuvir, GS-7977, GS-5885, GS-9669, FDC, ribavirin, RBV, Pegylated Interferon, PEG-IFN, Chronic Hepatitis C Infection, HCV, Hepatitis, Genotype 1, Genotype 2, Genotype 3, GT 1, GT 2, GT 3, Hemophilia
Medical subject headings
Hepatitis, Hemophilia A

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SOFDrug

    Also called Sovaldi®, GS-7977, PSI-7977

    Sofosbuvir (SOF) tablets administered orally once daily

  • RBVDrug

    Also called Copegus®

    Ribavirin (RBV) capsules administered orally in a divided daily dose

  • PEGDrug

    Also called Pegasys®

    Peginterferon alfa-2a (PEG) administered via subcutaneous injection once weekly

  • LDVDrug

    Also called GS-5885

    Ledipasvir (LDV) tablets administered orally once daily

  • GS-9669Drug

    GS-9669 tablets administered orally once daily

  • LDV/SOFDrug

    Also called Harvoni®

    LDV/SOF fixed-dose combination (FDC) tablet administered once daily

Study groups in NCT01260350
Study groupRoleWhat they receive
Group 1: SOF+RBV 12 wk: GT 2 or 3, TNExperimentalTreatment-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.
Receives: Drug: SOF; Drug: RBV
Group 2: SOF+RBV 12 wk+PEG 4 wk: GT 2 or 3, TNExperimentalTreatment-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.
Receives: Drug: SOF; Drug: RBV; Drug: PEG
Group 3: SOF+RBV 12 wk+PEG 8 wk: GT 2 or 3, TNExperimentalTreatment-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.
Receives: Drug: SOF; Drug: RBV; Drug: PEG
Group 4: SOF+RBV+PEG 12 wk: GT 2 or 3, TNExperimentalTreatment-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.
Receives: Drug: SOF; Drug: RBV; Drug: PEG
Group 5: SOF 12 wk: GT 2 or 3, TNExperimentalTreatment-naive participants with genotype 2 or 3 HCV infection will receive SOF 400 mg once daily for 12 weeks.
Receives: Drug: SOF
Group 6: SOF+RBV+PEG 8 wk: GT 2 or 3, TNExperimentalTreatment-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.
Receives: Drug: SOF; Drug: RBV; Drug: PEG
Group 7: SOF+RBV 12 wk: GT 1, TEExperimentalTreatment-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.
Receives: Drug: SOF; Drug: RBV
Group 8: SOF+RBV 12 wk: GT 1, TNExperimentalTreatment-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.
Receives: Drug: SOF; Drug: RBV
Group 9: SOF+RBV 12 wk: GT 2 or 3, TEExperimentalTreatment-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.
Receives: Drug: SOF; Drug: RBV
Group 10: SOF+RBV 8 wk: GT 2 or 3, TNExperimentalTreatment-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.
Receives: Drug: SOF; Drug: RBV
Group 11: SOF+RBV 12 wk: GT 2 or 3, TNExperimentalTreatment-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.
Receives: Drug: SOF; Drug: RBV
Group 12: SOF+RBV+LDV 12 wk: GT 1, TEExperimentalTreatment-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.
Receives: Drug: SOF; Drug: RBV; Drug: LDV
Group 13: SOF+RBV+LDV 12 wk: GT 1, TNExperimentalTreatment-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.
Receives: Drug: SOF; Drug: RBV; Drug: LDV
Group 14: SOF+RBV+GS-9669 12 wk: GT 1, TEExperimentalTreatment-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.
Receives: Drug: SOF; Drug: RBV; Drug: GS-9669
Group 15: SOF+RBV+GS-9669 12 wk: GT 1, TNExperimentalTreatment-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.
Receives: Drug: SOF; Drug: RBV; Drug: GS-9669
Group 16: LDV/SOF FDC 12 wk: GT 1, fibrosisExperimentalTreatment-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.
Receives: Drug: LDV/SOF
Group 17: LDV/SOF FDC+RBV 12 wk: GT 1, fibrosisExperimentalTreatment-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.
Receives: Drug: RBV; Drug: LDV/SOF
Group 18: LDV/SOF FDC 12 wk: GT 2 or 3, TNExperimentalTreatment-naive participants with genotype 2 or 3 HCV infection will receive LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks.
Receives: Drug: LDV/SOF
Group 19: LDV/SOF FDC 12 wk: GT 2 or 3, TEExperimentalTreatment-experienced participants with genotype 2 or 3 HCV infection will receive LDV 90 mg/SOF 400 mg FDC once daily for 12 weeks.
Receives: Drug: LDV/SOF
Group 20: LDV/SOF FDC+RBV 12 wk: GT 1, hemophiliacExperimentalHemophiliac 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.
Receives: Drug: RBV; Drug: LDV/SOF
Group 21: LDV/SOF FDC+RBV 6 wk: GT 1, TNExperimentalTreatment-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.
Receives: Drug: RBV; Drug: LDV/SOF
Group 22: LDV/SOF FDC 6 wk: GT 1, TNExperimentalTreatment-naive participants with genotype 1 HCV infection were randomized to receive LDV 90 mg/SOF 400 mg FDC once daily for 6 weeks.
Receives: Drug: LDV/SOF

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Who Experienced Adverse Events

    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.

    Measured: Up to 12 weeks plus 30 days

Secondary outcomes (8)

  1. Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12)

    SVR12 was defined as HCV RNA < the limit of detection (LOD; < 15 IU/mL) 12 weeks after the last dose of study drug.

    Measured: Posttreatment Week 12

  2. Percentage of Participants With HCV RNA < LOD at Week 6

    Measured: Week 6

  3. Percentage of Participants With HCV RNA < LOD at Week 8

    Data are not presented for Group 21 which ended treatment after Week 6.

    Measured: Week 8

  4. Percentage of Participants With HCV RNA < LOD at Week 12

    Data are not presented for Groups 6, 10, and 21 which ended treatment after Week 8 or Week 6.

    Measured: Week 12

  5. Change From Baseline in HCV RNA at Week 6

    Measured: Baseline to Week 6

  6. Change From Baseline in HCV RNA at Week 8

    Data are not presented for Group 21 which ended treatment after Week 6.

    Measured: Baseline to Week 8

  7. Change From Baseline in HCV RNA at Week 12

    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.

    Measured: Baseline to Week 12

  8. Percentage of Participants With Virologic Failure

    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.

    Measured: Up to Posttreatment Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2010 (estimated)
  2. Study startDec 2010
  3. Primary completionOct 2013
  4. Study completionDec 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
292 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01260350
Sponsor's protocol ID
P7977-0523
Other IDs
Medsafe
Status last verified
Nov 2014
First submitted
13 Dec 2010
Last updated
17 Nov 2014
Data monitoring committee
No

Publications

  • Gane EJ, Stedman CA, Hyland RH, Ding X, Svarovskaia E, Subramanian GM, Symonds WT, McHutchison JG, Pang PS. Efficacy of nucleotide polymerase inhibitor sofosbuvir plus the NS5A inhibitor ledipasvir or the NS5B non-nucleoside inhibitor GS-9669 against HCV genotype 1 infection. Gastroenterology. 2014 Mar;146(3):736-743.e1. doi: 10.1053/j.gastro.2013.11.007. Epub 2013 Nov 18.

    PubMed 24262278

  • Gane EJ, Stedman CA, Hyland RH, Ding X, Svarovskaia E, Symonds WT, Hindes RG, Berrey MM. Nucleotide polymerase inhibitor sofosbuvir plus ribavirin for hepatitis C. N Engl J Med. 2013 Jan 3;368(1):34-44. doi: 10.1056/NEJMoa1208953.

    PubMed 23281974

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SOF, RBV and PEG in people with Chronic Hepatitis C Infection, run by Gilead Sciences at 2 sites in New Zealand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Who Experienced Adverse Events (time frame: Up to 12 weeks plus 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01260350, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in