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

May 24, 2017 updated by: Gilead Sciences

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
601

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
      • Kogarah, New South Wales, Australia, 2217
      • Westmead, New South Wales, Australia, 2145
    • Queensland
      • Brisbane, Queensland, Australia, 4029
      • Greenslopes, Queensland, Australia, 4120
      • Woolloongabba, Queensland, Australia, 4102
    • South Australia
      • Adelaide, South Australia, Australia, 5000
    • Victoria
      • Clayton, Victoria, Australia, 3168
      • Fitzroy, Victoria, Australia, 3065
      • Heidelberg, Victoria, Australia, 3084
      • Melbourne, Victoria, Australia, 3004
    • Western Australia
      • Nedlands Perth, Western Australia, Australia, 6009
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
      • Edmonton, Alberta, Canada, T6G 2B7
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
      • Vancouver, British Columbia, Canada, V6Z 2K5
      • Vancouver, British Columbia, Canada, V6Z 2C7
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 3P4
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4A6
      • London, Ontario, Canada, N6A 5A5
      • Ottawa, Ontario, Canada, K1H 8L6
      • Toronto, Ontario, Canada, M5T 2S8
      • Toronto, Ontario, Canada, M6H 3M1
    • Quebec
      • Montreal, Quebec, Canada, H2X 3J4
      • Québec, Quebec, Canada, G1V 4G2
  • New Zealand
      • Wellington, New Zealand, 6021
    • Auckland
      • Grafton, Auckland, New Zealand, 1010
      • Grafton, Auckland, New Zealand, 1023
    • Chatham Islands
      • Christchurch, Chatham Islands, New Zealand, 8011
    • Waikato
      • Hamilton, Waikato, New Zealand, 3204
  • United Kingdom
      • Birmingham, United Kingdom, B9 5SS
      • Bradford, United Kingdom, BD9 6RJ
      • Dundee, United Kingdom, DD1 9SY
      • Edinburgh, United Kingdom, EH16 4SA
      • Edinburgh, United Kingdom, EH4 2XU
      • Frimley, United Kingdom, GU46 6HU
      • Glasgow, United Kingdom, G12 0YN
      • Glasgow, United Kingdom, G4 0SF
      • Leeds, United Kingdom, LS9 7TF
      • Liverpool, United Kingdom, L7 8XP
      • London, United Kingdom, NW3 2QG
      • London, United Kingdom, SW10 9NH
      • Manchester, United Kingdom, M85RB
      • Newcastle Upon Tyne, United Kingdom, NE7 7DN
      • Nottingham, United Kingdom, NG7 2UH
      • Oxford, United Kingdom, OX3 9DU
      • Plymouth, United Kingdom, PL6 8DH
      • Portsmouth, United Kingdom, PO6 3LY
      • Southampton, United Kingdom, SO16 6YD
    • Birmingham
      • Edgbaston, Birmingham, United Kingdom, B15 2TH
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
    • LN
      • London, LN, United Kingdom, E1 1BB
      • London, LN, United Kingdom, SE5 9RS
      • London, LN, United Kingdom, SW17 ORE
      • London, LN, United Kingdom, W2 1NY
  • United States
    • California
      • Riverside, California, United States, 92501
      • San Diego, California, United States, 92123
      • San Francisco, California, United States, 94115
    • Colorado
      • Aurora, Colorado, United States, 80045
      • Englewood, Colorado, United States, 80113
    • Florida
      • Miami, Florida, United States, 33136
      • Wellington, Florida, United States, 33414
    • Georgia
      • Marietta, Georgia, United States, 30060
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
    • Michigan
      • Novi, Michigan, United States, 48377
    • Minnesota
      • Saint Paul, Minnesota, United States, 55114
    • New Jersey
      • Hillsborough, New Jersey, United States, 08844
      • Newark, New Jersey, United States, 07102
    • New York
      • Binghamton, New York, United States, 13903
      • New York, New York, United States, 10021
    • Tennessee
      • Germantown, Tennessee, United States, 38138
      • Nashville, Tennessee, United States, 37211
      • Nashville, Tennessee, United States, 37212-1610
    • Texas
      • Arlington, Texas, United States, 76012
      • Austin, Texas, United States, 78705
    • Virginia
      • Norfolk, Virginia, United States, 23502
    • Washington
      • Seattle, Washington, United States, 98101

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  • 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
  • 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.

Key Exclusion Criteria:

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: SOF+RBV 16 weeks
SOF+RBV for 16 weeks
Drug: SOF
400 mg tablet administered orally once daily
Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977
Drug: RBV
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)
Experimental: SOF+RBV 24 weeks
SOF+RBV for 24 weeks
Drug: SOF
400 mg tablet administered orally once daily
Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977
Drug: RBV
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)
Experimental: SOF+RBV+Peg-IFN 12 weeks
SOF+RBV+Peg-IFN for 12 weeks
Drug: SOF
400 mg tablet administered orally once daily
Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977
Drug: RBV
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)
Drug: Peg-IFN
180 µg administered via subcutaneous injection once weekly
Experimental: Retreatment Substudy
Participants 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.
Drug: SOF
400 mg tablet administered orally once daily
Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977
Drug: RBV
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)
Drug: Peg-IFN
180 µg administered via subcutaneous injection once weekly

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
Time Frame: Posttreatment Week 12
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.
Posttreatment Week 12
Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event
Time Frame: Up to 24 weeks
Up to 24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
Time Frame: Posttreatment Weeks 4 and 24
SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.
Posttreatment Weeks 4 and 24
Change From Baseline in HCV RNA at Weeks 1, 2, 4, 8, and 12
Time Frame: Baseline; Weeks 1, 2, 4, 8, and 12
Baseline; Weeks 1, 2, 4, 8, and 12
Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 8, 12, 16, 20, and 24
Time Frame: Weeks 1, 2, 4, 8, 12, 16, 20, and 24
Weeks 1, 2, 4, 8, 12, 16, 20, and 24
HCV RNA at Weeks 1, 2, 4, 8, and 12
Time Frame: Weeks 1, 2, 4, 8, and 12
Weeks 1, 2, 4, 8, and 12
Percentage of Participants Experiencing On-Treatment Virologic Failure
Time Frame: Up to 24 weeks

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)
Up to 24 weeks
Percentage of Participants Experiencing Viral Relapse
Time Frame: Up to Posttreatment Week 24
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.
Up to Posttreatment Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gilead Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 24, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 7, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 7, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 10, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 14, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 20, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 24, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GS-US-334-0153
  • 2013-002641-11 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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