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Hepatitis CPhase 3NCT01962441

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

A Phase 3 study testing SOF, RBV and Peg-IFN in people with Hepatitis C, run by Gilead Sciences at 78 sites in 5 countries.

Completed

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

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatitis C
What is being tested?
SOF, RBV and Peg-IFN
Could I receive a placebo?
No, everyone receives an active treatment
How many people
601 participants
Where
78 sitesin 5 countries
Study dates
24 Sep 2013to 7 Jul 2016
Phase
Phase 3
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

  • 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
Show all 10Show fewer
  • 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.

Who cannot join

  • 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.
Show all 12Show fewer
  • 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.

Trial locations and contacts

78 sites in 5 countries.

78 sites in 5 countries

United Kingdom25 sites

  • Study site

    Birmingham, B9 5SS

  • Study site

    Bradford, BD9 6RJ

  • Study site

    Cambridge, Cambridgeshire, CB2 0QQ

  • Study site

    Dundee, DD1 9SY

  • Study site

    Edgbaston, Birmingham, B15 2TH

  • Study site

    Edinburgh, EH16 4SA

  • Study site

    Edinburgh, EH4 2XU

  • Study site

    Frimley, GU46 6HU

  • Study site

    Glasgow, G12 0YN

  • Study site

    Glasgow, G4 0SF

  • Study site

    Leeds, LS9 7TF

  • Study site

    Liverpool, L7 8XP

  • Study site

    London, LN, E1 1BB

  • Study site

    London, LN, SE5 9RS

  • Study site

    London, LN, SW17 ORE

  • Study site

    London, LN, W2 1NY

  • Study site

    London, NW3 2QG

  • Study site

    London, SW10 9NH

  • Study site

    Manchester, M85RB

  • Study site

    Newcastle upon Tyne, NE7 7DN

  • Study site

    Nottingham, NG7 2UH

  • Study site

    Oxford, OX3 9DU

  • Study site

    Plymouth, PL6 8DH

  • Study site

    Portsmouth, PO6 3LY

  • Study site

    Southampton, SO16 6YD

Other trials in United Kingdom

United States23 sites

  • Study site

    Arlington, Texas, 76012

  • Study site

    Aurora, Colorado, 80045

  • Study site

    Austin, Texas, 78705

  • Study site

    Binghamton, New York, 13903

  • Study site

    Boston, Massachusetts, 02215

  • Study site

    Englewood, Colorado, 80113

  • Study site

    Germantown, Tennessee, 38138

  • Study site

    Hillsborough, New Jersey, 08844

  • Study site

    Marietta, Georgia, 30060

  • Study site

    Miami, Florida, 33136

  • Study site

    Nashville, Tennessee, 37211

  • Study site

    Nashville, Tennessee, 37212-1610

  • Study site

    New Orleans, Louisiana, 70121

  • Study site

    New York, New York, 10021

  • Study site

    Newark, New Jersey, 07102

  • Study site

    Norfolk, Virginia, 23502

  • Study site

    Novi, Michigan, 48377

  • Study site

    Riverside, California, 92501

  • Study site

    Saint Paul, Minnesota, 55114

  • Study site

    San Diego, California, 92123

  • Study site

    San Francisco, California, 94115

  • Study site

    Seattle, Washington, 98101

  • Study site

    Wellington, Florida, 33414

Other trials in United States

Canada13 sites

  • Study site

    Calgary, Alberta, T2N 4Z6

  • Study site

    Edmonton, Alberta, T6G 2B7

  • Study site

    Hamilton, Ontario, L8N 4A6

  • Study site

    London, Ontario, N6A 5A5

  • Study site

    Montreal, Quebec, H2X 3J4

  • Study site

    Ottawa, Ontario, K1H 8L6

  • Study site

    Québec, Quebec, G1V 4G2

  • Study site

    Toronto, Ontario, M5T 2S8

  • Study site

    Toronto, Ontario, M6H 3M1

  • Study site

    Vancouver, British Columbia, V5Z 1M9

  • Study site

    Vancouver, British Columbia, V6Z 2C7

  • Study site

    Vancouver, British Columbia, V6Z 2K5

  • Study site

    Winnipeg, Manitoba, R3E 3P4

Other trials in Canada

Australia12 sites

  • Study site

    Adelaide, South Australia, 5000

  • Study site

    Brisbane, Queensland, 4029

  • Study site

    Camperdown, New South Wales, 2050

  • Study site

    Clayton, Victoria, 3168

  • Study site

    Fitzroy, Victoria, 3065

  • Study site

    Greenslopes, Queensland, 4120

  • Study site

    Heidelberg, Victoria, 3084

  • Study site

    Kogarah, New South Wales, 2217

  • Study site

    Melbourne, Victoria, 3004

  • Study site

    Nedlands Perth, Western Australia, 6009

  • Study site

    Westmead, New South Wales, 2145

  • Study site

    Woolloongabba, Queensland, 4102

Other trials in Australia

New Zealand5 sites

  • Study site

    Christchurch, Chatham Islands, 8011

  • Study site

    Grafton, Auckland, 1010

  • Study site

    Grafton, Auckland, 1023

  • Study site

    Hamilton, Waikato Region, 3204

  • Study site

    Wellington, 6021

Other trials in New Zealand

About this study

Official 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.

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.

Conditions
Hepatitis C
Being tested
SOF, RBV, Peg-IFN
Keywords
7977, GS-7977, PSI-7977, Sofosbuvir (SOF), Pegylated Interferon (Peg-IFN), Ribavirin (RBV)
Medical subject headings
Hepatitis C

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

    400 mg tablet administered orally once daily

  • RBVDrug

    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

    180 µg administered via subcutaneous injection once weekly

Study groups in NCT01962441
Study groupRoleWhat they receive
SOF+RBV 16 weeksExperimentalSOF+RBV for 16 weeks
Receives: Drug: SOF; Drug: RBV
SOF+RBV 24 weeksExperimentalSOF+RBV for 24 weeks
Receives: Drug: SOF; Drug: RBV
SOF+RBV+Peg-IFN 12 weeksExperimentalSOF+RBV+Peg-IFN for 12 weeks
Receives: Drug: SOF; Drug: RBV; Drug: Peg-IFN
Retreatment SubstudyExperimentalParticipants 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.
Receives: Drug: SOF; Drug: RBV; Drug: Peg-IFN

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 (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)

    SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.

    Measured: Posttreatment Week 12

  2. Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

    Measured: Up to 24 weeks

Secondary outcomes (6)

  1. Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)

    SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.

    Measured: Posttreatment Weeks 4 and 24

  2. Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24

    Measured: Weeks 1, 2, 4, 8, 12, 16, 20, and 24

  3. HCV RNA at Weeks 1, 2, 4, 8, and 12

    Measured: Weeks 1, 2, 4, 8, and 12

  4. Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12

    Measured: Baseline; Weeks 1, 2, 4, 8, and 12

  5. Percentage of Participants Experiencing 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 24 weeks

  6. 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 posted14 Oct 2013 (estimated)
  2. Study start24 Sep 2013
  3. Primary completion7 Jan 2015
  4. Study completion7 Jul 2016

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
601 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01962441
Sponsor's protocol ID
GS-US-334-0153
Other IDs
2013-002641-11
Status last verified
May 2017
First submitted
10 Oct 2013
Last updated
20 Jun 2017
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Foster GR, Pianko S, Brown A, Forton D, Nahass RG, George J, Barnes E, Brainard DM, Massetto B, Lin M, Han B, McHutchison JG, Subramanian GM, Cooper C, Agarwal K; BOSON Study Group. Efficacy of sofosbuvir plus ribavirin with or without peginterferon-alfa in patients with hepatitis C virus genotype 3 infection and treatment-experienced patients with cirrhosis and hepatitis C virus genotype 2 infection. Gastroenterology. 2015 Nov;149(6):1462-70. doi: 10.1053/j.gastro.2015.07.043. Epub 2015 Aug 4.

    PubMed 26248087

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SOF, RBV and Peg-IFN in people with Hepatitis C, run by Gilead Sciences at 78 sites in 5 countries.

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 10 inclusion and 12 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 20 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 78 sites in United Kingdom, United States, Canada, Australia, 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 5 Feb 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 (SVR) 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 NCT01962441, which also lists 1 linked publication.

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 20 Jun 2017.

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Clinical Trial NCT01962441 | AzTrials