Chronic Hepatitis CPhase 3NEUTRINONCT01641640
Sofosbuvir With Peginterferon Alfa 2a and Ribavirin for 12 Weeks in Treatment-Naive Subjects With Chronic Genotype 1, 4, 5, or 6 HCV Infection
A Phase 3 study testing Sofosbuvir, RBV and PEG in people with Chronic Hepatitis C, run by Gilead Sciences at 56 sites in 2 countries.
Trial summary
This study was to assess whether sofosbuvir in combination with ribavirin (RBV) and pegylated interferon alfa 2a (PEG) administered for 12 weeks is safe and effective in patients with hepatitis C virus (HCV) genotypes 1, 4, 5 , or 6 as assessed by the rate of sustained viral response (SVR) 12 weeks after… 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?
- Sofosbuvir, RBV and PEG
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 328 participants
- Where
- 56 sitesin 2 countries
- Study dates
- Jun 2012to Apr 2013
- 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
- Infection with HCV genotype 1, 4, 5, or 6
- Cirrhosis determination
- Subject met the following classifications:
- Treatment-naive
- Screening laboratory values within defined thresholds
- Not treated with any investigational drug or device within 30 days of screening
- Use of highly effective contraception methods if female of childbearing potential or sexually active male
Who cannot join
- Prior exposure to an direct-acting antiviral targeting the HCV nonstructural protein (NS)5B polymerase
- Pregnant or nursing female, or male with pregnant female partner
- Current or prior history of clinical hepatic decompensation
- History of clinically-significant illness or any other major medical disorder that may have interfered with subject treatment, assessment, or compliance with the protocol
- Excessive alcohol ingestion or significant drug abuse
Trial locations and contacts
56 sites in 2 countries.
56 sites in 2 countries
United States55 sites
Asheville Gastroenterology Associates, P.A.
Asheville, North Carolina, 28801
Digestive Healthcare of Georgia
Atlanta, Georgia, 30309
University of Colorado
Aurora, Colorado, 80045
Gastroenterology Associates, LLC
Baton Rouge, Louisiana, 70809
Comprehensive Clinical Research
Berlin, New Jersey, 08009
Binghamton Gastroenterology Associates
Binghamton, New York, 13903
University of Alabama Birmingham
Birmingham, Alabama, 35294-2170
Massachusetts General Hospital
Boston, Massachusetts, 02114
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Graves-Gilbert Clinic
Bowling Green, Kentucky, 42101
SCTI Research Foundation
Coronado, California, 92118
Southwest Infectious Disease Clinical Research, Inc.
Dallas, Texas, 75219
Infectious Disease Specialist of Atlanta
Decatur, Georgia, 30033
Duke University Medical Center
Durham, North Carolina, 27710
South Denver Gastroenterology, PC
Englewood, Colorado, 80113
Metropolitan Research
Fairfax, Virginia, 22031
Inova Fairfax Hospital Center for Liver Diseases
Falls Church, Virginia, 22042
University of Florida
Gainesville, Florida, 32610-0277
Gastro One
Germantown, Tennessee, 38138
ID Care
Hillsborough, New Jersey, 08844
Research Specialists of Texas
Houston, Texas, 77030
Indianapolis Gastroenterology Research Foundation
Indianapolis, Indiana, 46237
Borland-Groover Clinic Baptist
Jacksonville, Florida, 32256
Kansas City Gastroenterology and Hepatology
Kansas City, Missouri, 64131
Kaiser Permanente
Los Angeles, California, 90027
Peter J. Ruane, MD, Inc.
Los Angeles, California, 90036
Anthony Mills MD, Inc.
Los Angeles, California, 90069
Johns Hopkins University
Lutherville, Maryland, 21093
Gastrointestinal Specialists of Georgia, PC
Marietta, Georgia, 30060
University of Miami Center for Liver Diseases
Miami, Florida, 33136
Nashville Gastrointestinal Specialists, Inc
Nashville, Tennessee, 37211
Advanced Research Institute
New Port Richey, Florida, 34653
Weill Cornell Medical College
New York, New York, 10021
Mount Sinai School of Medicine
New York, New York, 10029
Digestive and Liver Disease Specialists
Norfolk, Virginia, 23502
Henry Ford Health System
Novi, Michigan, 48377
Orlando Immunology Center (ACH)
Orlando, Florida, 32803-1851
Internal Medicine Specialists
Orlando, Florida, 32806
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
University Gastroenterology
Providence, Rhode Island, 02905
The Miriam Hospital
Providence, Rhode Island, 02906
Bon Secours St. Mary's Hospital of Richmond, Inc.
Richmond, Virginia, 23226
Minnesota Gastroenterology, P.A.
Saint Paul, Minnesota, 55114
Alamo Medical Research
San Antonio, Texas, 78215
University of California San Diego
San Diego, California, 92103
Medical Associates Research Group, Inc.
San Diego, California, 92123
Kaiser Permanente
San Diego, California, 92154
Quest Clinical Research
San Francisco, California, 94115
Southwest C.A.R.E. Center
Santa Fe, New Mexico, 87505
Virginia Mason Medical Center
Seattle, Washington, 98101
The Research Institute
Springfield, Massachusetts, 01105
Whitman Walker Clinic
Washington D.C., District of Columbia, 20009
Capital Medical Associates
Washington D.C., District of Columbia, 20036
South Florida Center of Gastroenterology, P.A.
Wellington, Florida, 33414
Digestive Health Specialists, PA
Winston-Salem, North Carolina, 27103
About this study
Official title: A Phase 3, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of GS-7977 With Peginterferon Alfa 2a and Ribavirin for 12 Weeks in Treatment-Naive Subjects With Chronic Genotype 1, 4, 5, or 6 HCV Infection
This study was to assess whether sofosbuvir in combination with ribavirin (RBV) and pegylated interferon alfa 2a (PEG) administered for 12 weeks is safe and effective in patients with hepatitis C virus (HCV) genotypes 1, 4, 5 , or 6 as assessed by the rate of sustained viral response (SVR) 12 weeks after discontinuation of therapy (SVR12).
- Conditions
- Chronic Hepatitis C
- Being tested
- Sofosbuvir, RBV, PEG
- Keywords
- HCV genotype 1 (GT-1), HCV genotype 4 (GT-4), HCV genotype 5 (GT-5), HCV genotype 6 (GT-6), HCV, Sustained Virologic Response, Direct Acting Antiviral, Combination Therapy, Treatment-Naïve, GS-7977, Ribavirin, RBV, Peginterferon Alfa 2a, PEG
- 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.
SofosbuvirDrug
Also called Sovaldi®, GS-7977, PSI-7977
Sofosbuvir 400 mg tablet administered orally once daily
RBVDrug
Also called Ribasphere®
Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
PEGDrug
Also called PEGASYS®
Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Sofosbuvir+PEG+RBV | Experimental | Not described Receives: Drug: Sofosbuvir; Drug: RBV; Drug: PEG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving Sustained Virologic Response (SVR)12
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) 12 weeks after cessation of therapy.
Measured: Posttreatment Week 12
Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug
The number of participants experiencing adverse events leading to permanent discontinuation of study drug was summarized. Adverse events may or may not have been related to study treatment. Participants discontinuing study drug were permitted to remain on the study for further assessments.
Measured: Baseline to Week 12
Secondary outcomes (4)
Percentage of Participants Achieving SVR4
SVR4 was defined as HCV RNA < LLOQ 4 weeks after cessation of therapy
Measured: Posttreatment Week 4
Percentage of Participants Achieving SVR24
SVR24 was defined as HCV RNA < LLOQ 24 weeks after cessation of therapy
Measured: Posttreatment Week 24
Percentage of Participants With Viral Breakthrough
Viral breakthrough was defined as HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while receiving treatment, confirmed with 2 consecutive values (second confirmation value could be posttreatment), or last available on-treatment measurement with no subsequent follow-up values.
Measured: Baseline to Week 12
Percentage of Participants With Viral Relapse
Viral relapse was defined as HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement.
Measured: End of treatment to post-treatment Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2012 (estimated)
- Study startJun 2012
- Primary completionJan 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis CStudies of the same condition, open and under way.
- More trials run by Gilead SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 328 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01641640
- Sponsor's protocol ID
- GS-US-334-0110
- Acronym
- NEUTRINO
- Status last verified
- Apr 2014
- First submitted
- 9 Jul 2012
- Last updated
- 8 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Lawitz E, Mangia A, Wyles D, Rodriguez-Torres M, Hassanein T, Gordon SC, Schultz M, Davis MN, Kayali Z, Reddy KR, Jacobson IM, Kowdley KV, Nyberg L, Subramanian GM, Hyland RH, Arterburn S, Jiang D, McNally J, Brainard D, Symonds WT, McHutchison JG, Sheikh AM, Younossi Z, Gane EJ. Sofosbuvir for previously untreated chronic hepatitis C infection. N Engl J Med. 2013 May 16;368(20):1878-87. doi: 10.1056/NEJMoa1214853. Epub 2013 Apr 23.
PubMed 23607594Younossi ZM, Stepanova M, Henry L, Gane E, Jacobson IM, Lawitz E, Nelson D, Gerber L, Nader F, Hunt S. Effects of sofosbuvir-based treatment, with and without interferon, on outcome and productivity of patients with chronic hepatitis C. Clin Gastroenterol Hepatol. 2014 Aug;12(8):1349-59.e13. doi: 10.1016/j.cgh.2013.11.032. Epub 2013 Dec 6.
PubMed 24316172Stepanova M, Nader F, Cure S, Bourhis F, Hunt S, Younossi ZM. Patients' preferences and health utility assessment with SF-6D and EQ-5D in patients with chronic hepatitis C treated with sofosbuvir regimens. Aliment Pharmacol Ther. 2014 Sep;40(6):676-85. doi: 10.1111/apt.12880. Epub 2014 Jul 15.
PubMed 25040192
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of GS-7977 With Peginterferon Alfa 2a and Ribavirin for 12 Weeks in Treatment-Naive Subjects With Chronic Genotype 1, 4, 5, or 6 HCV Infection
- ClinicalTrials.gov ID
- NCT01641640
- Acronym / sponsor ID
- NEUTRINO / GS-US-334-0110
- Conditions
- Chronic Hepatitis C
- Keywords
- HCV genotype 1 (GT-1), HCV genotype 4 (GT-4), HCV genotype 5 (GT-5), HCV genotype 6 (GT-6), HCV, Sustained Virologic Response, Direct Acting Antiviral, Combination Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 328 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 17 Jul 2012 (estimated)
- Results
- Posted 8 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was to assess whether sofosbuvir in combination with ribavirin (RBV) and pegylated interferon alfa 2a (PEG) administered for 12 weeks is safe and effective in patients with hepatitis C virus (HCV) genotypes 1, 4, 5 , or 6 as assessed by the rate of sustained viral response (SVR) 12 weeks after discontinuation of therapy (SVR12).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sofosbuvir+PEG+RBV | Experimental | Drug: Sofosbuvir, Drug: RBV, Drug: PEG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Infection with HCV genotype 1, 4, 5, or 6
- Cirrhosis determination
- Subject met the following classifications:
- Use of highly effective contraception methods if female of childbearing potential or sexually active male
Key exclusion criteria (5 listed)
- Prior exposure to an direct-acting antiviral targeting the HCV nonstructural protein (NS)5B polymerase
- Pregnant or nursing female, or male with pregnant female partner
- Current or prior history of clinical hepatic decompensation
- History of clinically-significant illness or any other major medical disorder that may have interfered with subject treatment, assessment, or compliance with the protocol
- Excessive alcohol ingestion or significant drug abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SofosbuvirAlso: Sovaldi®, GS-7977, PSI-7977Sofosbuvir 400 mg tablet administered orally once daily | Drug | Sofosbuvir+PEG+RBV |
| RBVAlso: Ribasphere®Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg) | Drug | Sofosbuvir+PEG+RBV |
| PEGAlso: PEGASYS®Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection | Drug | Sofosbuvir+PEG+RBV |
Primary outcome
Percentage of Participants Achieving Sustained Virologic Response (SVR)12
Time frame: Posttreatment Week 12
SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 25 IU/mL) 12 weeks after cessation of therapy.
Number of Participants Experiencing Adverse Events Leading to Permanent Discontinuation of Study Drug
Time frame: Baseline to Week 12
The number of participants experiencing adverse events leading to permanent discontinuation of study drug was summarized. Adverse events may or may not have been related to study treatment. Participants discontinuing study drug were permitted to remain on the study for further assessments.
4 secondary outcomes
Percentage of Participants Achieving SVR4
Time frame: Posttreatment Week 4
Percentage of Participants Achieving SVR24
Time frame: Posttreatment Week 24
Percentage of Participants With Viral Breakthrough
Time frame: Baseline to Week 12
Percentage of Participants With Viral Relapse
Time frame: End of treatment to post-treatment Week 24
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23607594Lawitz E, Mangia A, Wyles D, Rodriguez-Torres M, Hassanein T, Gordon SC, Schultz M, Davis MN, Kayali Z, Reddy KR, Jacobson IM, Kowdley KV, Nyberg L, Subramanian GM, Hyland RH, Arterburn S, Jiang D, McNally J, Brainard D, Symonds WT, McHutchison JG, Sheikh AM, Younossi Z, Gane EJ. Sofosbuvir for previously untreated chronic hepatitis C infection. N Engl J Med. 2013 May 16;368(20):1878-87. doi: 10.1056/NEJMoa1214853. Epub 2013 Apr 23.
- Results publication: PubMed 24316172Younossi ZM, Stepanova M, Henry L, Gane E, Jacobson IM, Lawitz E, Nelson D, Gerber L, Nader F, Hunt S. Effects of sofosbuvir-based treatment, with and without interferon, on outcome and productivity of patients with chronic hepatitis C. Clin Gastroenterol Hepatol. 2014 Aug;12(8):1349-59.e13. doi: 10.1016/j.cgh.2013.11.032. Epub 2013 Dec 6.
- Derived from this study: PubMed 25040192Stepanova M, Nader F, Cure S, Bourhis F, Hunt S, Younossi ZM. Patients' preferences and health utility assessment with SF-6D and EQ-5D in patients with chronic hepatitis C treated with sofosbuvir regimens. Aliment Pharmacol Ther. 2014 Sep;40(6):676-85. doi: 10.1111/apt.12880. Epub 2014 Jul 15.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
56 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sofosbuvir, RBV and PEG in people with Chronic Hepatitis C, run by Gilead Sciences at 56 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 7 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 8 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 56 sites in United States, Puerto Rico. 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 8 May 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 Achieving Sustained Virologic Response (SVR)12 (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 NCT01641640, which also lists 3 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 8 May 2014.