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Hepatitis C Virus InfectionPhase 2NCT02994056

Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 Weeks in Participants With Chronic HCV Infection and Child-Pugh-Turcotte Class C Cirrhosis

A Phase 2 study testing SOF/VEL and RBV in people with Hepatitis C Virus Infection, run by Gilead Sciences at 12 sites in 2 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

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of the treatment with sofosbuvir velpatasvir (SOF/VEL) fixed-dose combination (FDC) with ribavirin (RBV) for 12 weeks in participants with chronic hepatitis C virus (HCV) infection and Child-Pugh-Turcotte (CPT) Class C… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatitis C Virus Infection
What is being tested?
SOF/VEL and RBV
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
12 sitesin 2 countries
Study dates
23 Jan 2017to 12 Dec 2018
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

  • A body mass index (BMI) of ≥ 18 kg/m^2
  • Chronic HCV infection (≥ 6 months) as documented by either prior medical history or liver biopsy
  • Quantifiable HCV RNA at screening
  • Individuals may be non-transplanted or with recurrent HCV post-liver transplant.
  • If listed for liver transplant, then the projected date of transplant must be ≥12 weeks after Day1 of treatment
  • If post-liver transplant, then Day1 must be ≥ 6 months from date of transplant
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  • CPT score of 10 to 12, inclusive, as determined at screening
  • Liver imaging within 6 months of Day 1 to exclude hepatocellular carcinoma (HCC)
  • If treatment-experienced, the most recent HCV treatment must have been completed at least 8 weeks prior to Screening
  • Females of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test on Day 1 prior to randomization
  • Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
  • Females must agree to refrain from egg donation and in vitro fertilization during treatment until at least 30 days after the last dose of SOF/VEL or 6 months after the last dose of RBV, whichever occurs last
  • Lactating females must agree to discontinue nursing before the study drugs are administered
  • Males must agree to refrain from sperm donation from the date of screening until at least 7 months after the last dose of RBV or 30 days after the last dose of SOF/VEL, whichever occurs last
  • Adults must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments

Who cannot join

  • Current or prior history of any of the following:
  • Clinically significant medical or psychiatric illness or individual is currently under evaluation for a potentially clinically significant illness
  • Gastrointestinal disorder or post-operative condition that could interfere with the absorption of the study drug
  • Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy
  • Significant pulmonary disease, significant cardiac disease or porphyria
  • Malignancy within the 5 years prior to screening, with the exception of specific cancers that have been cured by surgical resection (basal cell skin cancer, etc.). Adults under evaluation for possible malignancy are not eligible
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  • Significant drug allergy (such as anaphylaxis or hepatotoxicity)
  • Any history of organ transplant other than liver or kidney
  • Chronic liver disease of a non-HCV etiology
  • Inability to exclude HCC by imaging within 6 months of Day 1
  • Alpha-fetoprotein (AFP) > 50 unless negative imaging for hepatic masses within the last 6 months or during screening
  • Active spontaneous bacterial peritonitis at screening
  • Infection requiring systemic antibiotics at the time of screening
  • Evidence of fibrosing cholestatic hepatitis at screening
  • Life threatening serious adverse event (SAE) during screening
  • Active variceal bleeding within 6 months of screening
  • Prior placement of a portosystemic shunt (such as TIPS)
  • ECG with clinically significant abnormalities
  • Laboratory parameters with clinically significant abnormalities
  • Hepatitis B surface antigen positive at screening
  • Infection with human immunodeficiency virus (HIV)
  • Clinically-relevant alcohol or drug abuse within 12 months of screening. A positive drug screen will exclude individuals unless it can be explained by a prescribed medication; the diagnosis and prescription must be approved by the Investigator
  • Prior exposure to any HCV Non-structural Protein 5A (NS5A) inhibitor
  • Current use of corticosteroids at any dose >10 mg of prednisone/day (or equivalent dose of corticosteroid)
  • Use of any prohibited concomitant medications
  • Use of granulocyte macrophage colony-stimulating factor (GM-CSF), epoetin alfa or other hematopoietic stimulating agents within 2 weeks of screening
  • Male with pregnant female partner
  • History of clinically significant hemoglobinopathy (eg, sickle cell disease, thalassemia)
  • Contraindications to RBV therapy
  • Known hypersensitivity to VEL, RBV, SOF, the metabolites, or formulation excipients
  • Participation in a clinical study with an investigational drug or biologic within 3 months prior to Day 1
  • NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Trial locations and contacts

12 sites in 2 countries.

12 sites in 2 countries

United States10 sites

  • Digestive Disease Associates, PA

    Catonsville, Maryland, 21228

  • Northwestern Memorial Hospital; Clinical Research Unit

    Chicago, Illinois, 60611

  • Southern Therapy and Advanced Research LLC

    Jackson, Mississippi, 39216

  • Intermountain Liver Disease and Transplant Center

    Murray, Utah, 84107

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Bon Secours St. Mary's Hospital of Richmond, Inc. d/b/a Bon Secours Liver Institute of Virginia

    Richmond, Virginia, 23226

  • American Research Corporation at Texas Liver Institute

    San Antonio, Texas, 78215

  • University of Washington/ Harborview Medical Center

    Seattle, Washington, 98105

  • Tampa General Medical Group

    Tampa, Florida, 33606

Other trials in United States

France2 sites

  • Hopital Henri Mondor

    Créteil, 94010

  • Hopital Paul Brousse

    Villejuif, 94800

Other trials in France

About this study

Official title: A Phase 2, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 Weeks in Subjects With Chronic HCV Infection and Child-Pugh-Turcotte Class C Cirrhosis

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of the treatment with sofosbuvir velpatasvir (SOF/VEL) fixed-dose combination (FDC) with ribavirin (RBV) for 12 weeks in participants with chronic hepatitis C virus (HCV) infection and Child-Pugh-Turcotte (CPT) Class C cirrhosis.

Being tested
SOF/VEL, 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.

  • SOF/VELDrug

    Also called Epclusa®, GS-7977/GS-5816

    400/100 mg FDC tablet administered orally once daily

  • RBVDrug

    Tablets administered orally at 600 mg, if well tolerated then up to a maximum total daily dose of 1000 to 1200 mg (based on weight) divided twice daily.

Study groups in NCT02994056
Study groupRoleWhat they receive
SOF/VEL+ RBVExperimentalSOF/VEL FDC plus RBV for 12 weeks
Receives: Drug: SOF/VEL; Drug: RBV

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 Study Drug (SOF/VEL or RBV) Due to an Adverse Event

    Measured: First dose date up to Week 12

Secondary outcomes (8)

  1. Percentage of Participants With Sustained Virologic Response 4 Weeks After Discontinuation of Therapy (SVR4)

    SVR4 was defined as HCV RNA < LLOQ 4 weeks after stopping study treatment.

    Measured: Posttreatment Week 4

  2. Percentage of Participants With Sustained Virologic Response 24 Weeks After Discontinuation of Therapy (SVR24)

    SVR24 was defined as HCV RNA < LLOQ at 24 weeks after stopping study treatment.

    Measured: Posttreatment Week 24

  3. Percentage of Participants With HCV RNA < LLOQ While on Study Treatment

    Measured: Weeks 2, 4, 8, and 12

  4. Percentage of Participants With No Change, Improved, and Worsened Child-Pugh-Turcotte (CPT) Class

    CPT is a chronic liver disease classification system. Classes include CPT Class A, CPT Class B, and CPT Class C, in order of greater disease severity. Participants with improved CPT class was defined as having Class C at Baseline and Class B or A at Posttreatment Week 24 or Class B at Baseline and Class A at Posttreatment Week 24. Participants with worsened CPT class was defined as having Class A at Baseline and Class B or C at Posttreatment Week 24 or Class B at Baseline and Class C at Posttreatment Week 24. Participants with no change CPT class was defined as having CPT Class same between Baseline and Posttreatment Week 24.

    Measured: Baseline to Posttreatment Week 24

  5. Percentage of Participants With a Decrease, No Change, or Increase in Model for End Stage Liver Disease (MELD) Score

    MELD score is a chronic liver disease severity scoring system. Scores can range from 6 to 40, with higher scores indicating greater disease severity. "No change" was assigned for differences (posttreatment visits minus baseline score) of -1, 0 or 1; "Decrease" was assigned for differences that were less than or equal to -2; and "Increase" was assigned for values that were greater than or equal to 2.

    Measured: Baseline to Posttreatment Week 24

  6. Absolute HCV RNA Level Through Week 12

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

  7. Change From Baseline in HCV RNA

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

  8. Number of Participants With Virologic Failure

    Virologic failure was defined as:

    • On-treatment virologic failure:
    • 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)
    • Virologic relapse:
    • Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit

    Measured: Baseline 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 2016 (estimated)
  2. Study start23 Jan 2017
  3. Primary completion25 Sep 2018
  4. Study completion12 Dec 2018

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02994056
Sponsor's protocol ID
GS-US-342-4022
Other IDs
2016-003066-10, 2016
Status last verified
Sep 2019
First submitted
13 Dec 2016
Last updated
2 Mar 2020
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
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 https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy.

Publications

  • Flamm S, Lawitz E, Borg B, Charlton M, Landis C, Reddy R, et al. High Efficacy and Improvement in CPT Class With Sofosbuvir/Velpatasvir Plus Ribavirin for 12 Weeks in Patients With CPT C Decompensated Cirrhosis [Poster THU-138]. EASL: The International Liver Congress; 2019 10-14 April; Vienna, Austria.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SOF/VEL and RBV in people with Hepatitis C Virus Infection, run by Gilead Sciences at 12 sites in 2 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 15 inclusion and 32 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 2 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States, France. 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 8 Oct 2019). 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 NCT02994056, 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 2 Mar 2020.

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