AzTrials
AzTrials

Chronic Hepatitis CPhase 2NCT01826981

Efficacy and Safety of Sofosbuvir Containing Regimens for the Treatment of Chronic HCV Infection in Participants With Chronic Genotype 1, 2, 3, or 6 HCV Infection

A Phase 2 study testing LDV/SOF, SOF and RBV in people with Chronic Hepatitis C, 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

The purpose of this study is to evaluate the antiviral efficacy, safety, tolerability of combination therapy with sofosbuvir (SOF) containing regimens for the treatment of chronic hepatitis C virus (HCV) infection. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Hepatitis C
What is being tested?
LDV/SOF, SOF and RBV
Could I receive a placebo?
No, everyone receives an active treatment
How many people
359 participants
Where
2 sitesNew Zealand
Study dates
Apr 2013to May 2015
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 1, 2, 3, or 6 HCV infection
  • Cirrhosis determination; a liver biopsy may be required
  • Screening laboratory values within defined thresholds
  • Use of two effective contraception methods if female of childbearing potential or sexually active male

Who cannot join

  • Pregnant or nursing female or male with pregnant female partner
  • Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)
  • Chronic use of systemic immunosuppressive agents
  • History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment or compliance with the protocol

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 Phase 2, Multicenter, Open-Label Study to Assess the Efficacy and Safety of Sofosbuvir Containing Regimens for the Treatment of Chronic HCV Infection

The purpose of this study is to evaluate the antiviral efficacy, safety, tolerability of combination therapy with sofosbuvir (SOF) containing regimens for the treatment of chronic hepatitis C virus (HCV) infection.

Being tested
LDV/SOF, SOF, RBV, Peg-IFN, GS-9669
Medical subject headings
Hepatitis C, Chronic

What participants receive

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

  • LDV/SOFDrug

    Also called Harvoni®, GS-5885/GS-7977

    Ledipasvir/sofosbuvir (LDV/SOF) (90 /400 mg) fixed-dose combination (FDC) tablet administered orally once daily

  • SOFDrug

    Also called GS-7977, Sovaldi®

    SOF 400 mg tablet administered orally once daily

  • RBVDrug

    Ribavirin (RBV) 200 mg 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)

  • Peg-IFNDrug

    Also called Pegasys®

    pegylated interferon (Peg-IFN) 180 µg administered subcutaneously once weekly

  • GS-9669Drug

    GS-9669 500 mg (2 × 250 mg tablet) administered orally once daily

  • VELDrug

    Also called GS-5816

    Velpatasvir (VEL) tablet(s) administered orally once daily

Study groups in NCT01826981
Study groupRoleWhat they receive
Cohort 1,Group 1: LDV/SOF + RBV 12 wk (GT1 SOF retreatment)ExperimentalLDV/SOF + RBV for 12 weeks in participants with genotype 1 HCV infection and who failed to achieve sustained virologic response (SVR) in a previous Gilead sofosbuvir study
Receives: Drug: LDV/SOF; Drug: RBV
Cohort 1,Group 2:SOF+Peg-IFN+RBV 12 wk (GT2,3 SOF retreatment)ExperimentalSOF + PEG + RBV for 12 weeks in participants with genotype 2 or 3 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
Receives: Drug: SOF; Drug: RBV; Drug: Peg-IFN
Cohort 2,Group 1: LDV/SOF+RBV 12 wk (GT 1 TE, liver disease)ExperimentalLDV/SOF+RBV for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
Receives: Drug: LDV/SOF; Drug: RBV
Cohort 2,Group 2: LDV/SOF+GS-9669 12wk (GT1 TE, liver disease)ExperimentalLDV/SOF + GS-9669 for 12 weeks in treatment-experienced participants with genotype 1 HCV infection and advanced liver fibrosis or compensated liver fibrosis
Receives: Drug: LDV/SOF; Drug: GS-9669
Cohort 2,Group 3: LDV/SOF 12 wk (GT3 TN)ExperimentalLDV/SOF for 12 weeks in treatment-naive participants with genotype 3 HCV infection
Receives: Drug: LDV/SOF
Cohort 2,Group 4: LDV/SOF+RBV 12 wk (GT3 TN)ExperimentalLDV/SOF + RBV for 12 weeks in treatment-naive participants with genotype 3 HCV infection
Receives: Drug: LDV/SOF; Drug: RBV
Cohort 2,Group 5: LDV/SOF 12 wk (GT6 TE/TN)ExperimentalLDV/SOF for 12 weeks in treatment-naive or treatment-experienced participants with genotype 6 HCV infection
Receives: Drug: LDV/SOF
Cohort 2,Group 6: LDV/SOF+RBV 12 wk (GT3 TE)ExperimentalLDV/SOF + RBV for 12 weeks in treatment-experienced participants with genotype 3 HCV infection
Receives: Drug: LDV/SOF; Drug: RBV
Cohort 3,Group 1: LDV/SOF 12 wk (GT1 cirrhotic CPT B)ExperimentalLDV/SOF for 12 weeks in participants with genotype 1 HCV infection and Child-Pugh Turcotte (CPT) B cirrhosis
Receives: Drug: LDV/SOF
Cohort 4,Group 1: SOF+VEL 25mg 8 wk (GT3 TN noncirrhotic)ExperimentalSOF+VEL (25 mg) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
Receives: Drug: SOF; Drug: VEL
Cohort 4,Group 2:SOF+VEL 25mg+RBV 8 wk (GT3 TN noncirrhotic)ExperimentalSOF+VEL(25 mg)+RBV for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
Receives: Drug: SOF; Drug: RBV; Drug: VEL
Cohort 4,Group 3: SOF+VEL 100mg 8 wk (GT3 TN noncirrhotic)ExperimentalSOF+VEL (100 mg) for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
Receives: Drug: SOF; Drug: VEL
Cohort 4,Group 4: SOF+VEL 100mg+RBV 8 wk (GT3 TN noncirrhotic)ExperimentalSOF+VEL (100 mg)+RBV for 8 weeks in treatment-naive noncirrhotic participants with genotype 3 HCV infection
Receives: Drug: SOF; Drug: RBV; Drug: VEL
Cohort 5,Group 1: LDV/SOF + RBV 24 wk (SOF retreatment)ExperimentalLDV/SOF+RBV for 24 weeks in participants with genotype 1, 2, 3, or 6 HCV infection and who failed to achieve SVR in a previous Gilead sofosbuvir study
Receives: Drug: LDV/SOF; Drug: RBV
Cohort 6,Group 1: LDV/SOF 12 wk (GT1, HBV coinfection)ExperimentalLDV/SOF for 12 weeks in participants with genotype 1 HCV and hepatitis B virus (HBV) coinfection
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 With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12)

    SVR12 is defined as HCV RNA < lower limit of quantification (LLOQ) at 12 weeks after stopping study treatment.

    Measured: Posttreatment Week 12

  2. Percentage of Participants With Adverse Events Leading to Permanent Discontinuation of Study Drug(s)

    Measured: Up to 24 weeks plus 30 days

Secondary outcomes (9)

  1. Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment

    Measured: Weeks 1 and 2

  2. Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment

    Measured: Weeks 4, 6, and 8

  3. Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment

    Measured: Week 10

  4. Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment

    Measured: Week 12

  5. Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) While on Treatment

    Measured: Weeks 16, 20, and 24

  6. Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 2, 4, 8, and 24 Weeks After Discontinuation of Therapy (SVR2, SVR4, SVR8, and SVR 24)

    Measured: Posttreatment Weeks 2, 4, 8, and 24

  7. For Cohort 6, Percentage of Participants With HCV RNA < LLOQ (15 IU/mL) at 16 and 20 Weeks After Discontinuation of Therapy (SVR16 and SVR 20)

    Measured: Posttreatment Weeks 16 and 20

  8. Percentage of Participants With On-treatment Virologic Failure

    On-treatment virologic failure was defined as:

    • Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
    • Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
    • Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)

    Measured: Up to Posttreatment Week 24

  9. Percentage of Participants Experiencing Viral Relapse

    Viral relapse is defined as HCV RNA ≥ LLOQ during the post-treatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available post-treatment measurement.

    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 posted9 Apr 2013 (estimated)
  2. Study startApr 2013
  3. Primary completionMar 2015
  4. Study completionMay 2015

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
359 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01826981
Sponsor's protocol ID
GS-US-337-0122
Status last verified
Sep 2016
First submitted
1 Apr 2013
Last updated
16 Nov 2018
Data monitoring committee
No
Individual data sharing
Yes: Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.

Publications

  • Gane EJ, Hyland RH, An D, Svarovskaia E, Pang PS, Brainard D, Stedman CA. Efficacy of ledipasvir and sofosbuvir, with or without ribavirin, for 12 weeks in patients with HCV genotype 3 or 6 infection. Gastroenterology. 2015 Nov;149(6):1454-1461.e1. doi: 10.1053/j.gastro.2015.07.063. Epub 2015 Aug 7.

    PubMed 26261007

  • Gane EJ, Hyland RH, An D, Svarovskaia ES, Brainard D, McHutchison JG. Ledipasvir and sofosbuvir for HCV infection in patients coinfected with HBV. Antivir Ther. 2016;21(7):605-609. doi: 10.3851/IMP3066. Epub 2016 Jul 1.

    PubMed 27367295

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing LDV/SOF, SOF and RBV in people with Chronic Hepatitis C, 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 4 inclusion and 4 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 16 Nov 2018. 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 16 Sep 2016). 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 With Sustained Virologic Response 12 Weeks After Discontinuation of Therapy (SVR12) (time frame: Posttreatment Week 12). The study lists 2 primary outcomes in all. 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 NCT01826981, 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 16 Nov 2018.

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