Hepatitis C VirusPhase 2NCT01188772
Sofosbuvir in Combination With Pegylated Interferon and Ribavirin and in Treatment-Naive Hepatitis C-infected Patients
A Phase 2 study testing Sofosbuvir, PEG and RBV in people with Hepatitis C Virus, run by Gilead Sciences at 23 sites in 2 countries.
Trial summary
Genotype 1: Participants with genotype 1 hepatitis C (HCV) infection were randomized to receive sofosbuvir (GS-7977; PSI-7977) 200 mg or 400 mg, or matching placebo, plus pegylated interferon alfa 2a (PEG) and ribavirin (RBV) for 12 weeks, followed by PEG+RBV for an up to an additional 36 weeks. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatitis C Virus
- What is being tested?
- Sofosbuvir, PEG and RBV
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 147 participants
- Where
- 23 sitesin 2 countries
- Study dates
- Aug 2010to May 2012
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females aged 18 to 70 years, inclusive, at screening
- Documented chronic genotype 1, 2, or 3 HCV infection
- No previous treatment with HCV antiviral mediations
- Body mass index (BMI) of greater than 18 kg/m2, but not exceeding 36 kg/m2.
- Liver biopsy obtained within 3 years prior to the Day 1 visit, with a fibrosis classification of non-cirrhotic as judged by a local pathologist
- Willing to refrain from beginning any new exercise regimens during the first 3 months of the study
- Fasting blood glucose ≤ 300 mg/dl and/or glycosylated hemoglobin (HbA1c) ≤ 8
- History of hypertension only if managed effectively on a stable regimen of two or fewer antihypertensives for at least three (3) months prior to screening
Who cannot join
- Females who were breastfeeding
- Males and females of reproductive potential who are unwilling to use an "effective", protocol-specified method(s) of contraception during the study
- Positive test at Screening for HBsAg, anti-HBc IgM Ab, or anti-HIV Ab.
- History of any other clinically significant chronic liver disease
- Treatment with herbal/natural remedies with antiviral activity within 30 days prior to baseline.
- Significant history of immunologically mediated disease, cardiac or pulmonary disease, seizure disorder or anticonvulsant use
Show all 17Show fewer
- History of ascites, variceal hemorrhage, hepatic encephalopathy, or conditions consistent with decompensated liver disease
- Use of medications associated with QT prolongation within 30 days prior to dosing
- Screening electrocardiogram (ECG) QTc value greater than 450 ms and/or clinically significant ECG findings
- Personal or family history of Torsade de pointes.
- Positive results for drugs of abuse test at screening
- Abnormal hematological and biochemical parameters, including alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 5 times the upper limit of the normal range (ULN)
- History of major organ transplantation with an existing functional graft
- History of uncontrolled thyroid disease or abnormal thyroid-stimulating hormone (TSH) levels at screening
- Clinically significant drug allergy to nucleoside/nucleotide analogs
- History or current evidence of psychiatric illness, immunologic disorder, pulmonary, cardiac disease, seizure disorder, cancer or history of malignancy that in the opinion of the investigator makes the patient unsuitable for the study
- History of systemic antineoplastic or immunomodulatory treatment within 6 months prior to dosing, or the expectation of such treatment during the study
Trial locations and contacts
23 sites in 2 countries.
23 sites in 2 countries
United States22 sites
Advanced Clinical Research Institute
Anaheim, California
Liver Research Center Beth Israel Deaconess Medical Center
Boston, Massachusetts
Dr. Jama Darling
Chapel Hill, North Carolina
University of Chicago
Chicago, Illinois
Columbia Gastroenterology and Liver Associates
Columbia, South Carolina
SCTI Research Foundation
Coronado, California
Dr. David Nelson
Gainesville, Florida
Kansas City Gastroenterology and Hepatology
Kansas City, Missouri
Cedars Sinai Medical Center
Los Angeles, California
Dr. Mark Sulkowski
Lutherville, Maryland
North Shore University Hospital
Manhasset, New York
Gastrointestinal Specialists of Georgia
Marietta, Georgia
Alabama Liver and Digestive Specialists
Montgomery, Alabama
Dr. Ira Jacobson
New York, New York
Mount Sinai School of Medicine
New York, New York
Orlando Immunology Center
Orlando, Florida
Dr. Raj Reddy
Philadelphia, Pennsylvania
Dr. Eric Lawitz
San Antonio, Texas
Dr. Jay Lalezari
San Francisco, California
Dr. Natalie Bzowej
San Francisco, California
Digestive Disease Institute Virginia Mason Medical Center
Seattle, Washington
Dr. Bruce Bacon
St Louis, Missouri
Puerto Rico1 site
Fundacion de Investigacion de Diego
Santurce, Puerto Rico
About this study
Official title: A Multi-center, Placebo-Controlled, Dose Ranging Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Oral Administration of PSI-7977 in Combination With Pegylated Interferon and Ribavirin in Treatment-Naïve Patients With Chronic HCV Infection Genotype 1, and an Open Label Assessment of PSI-7977 in Patients With HCV Genotypes 2 or 3
Genotype 1: Participants with genotype 1 hepatitis C (HCV) infection were randomized to receive sofosbuvir (GS-7977; PSI-7977) 200 mg or 400 mg, or matching placebo, plus pegylated interferon alfa 2a (PEG) and ribavirin (RBV) for 12 weeks, followed by PEG+RBV for an up to an additional 36 weeks. Randomization was stratified by IL28B status (CC, CT, TT) and HCV RNA level (< 800,000 IU/ml or ≥ 800,000 IU/ml) at baseline. Participants were randomized in a 2:2:1 manner; those who achieved an extended rapid virologic response (eRVR) (HCV RNA < lower limit of detection [15 IU/mL] from Weeks 4 through 12) received an additional 12 weeks of PEG+RBV. Subjects not achieving eRVR received an additional 36 weeks of PEG+RBV.
Genotype 2 and 3: Participants with genotype 2 or 3 hepatitis C (HCV) received sofosbuvir 400 mg plus PEG+RBV for 12 weeks.
- Conditions
- Hepatitis C Virus
- Being tested
- Sofosbuvir, Placebo to match sofosbuvir, PEG, RBV
- Keywords
- Hepatitis C Virus, HCV, hepatitis, Genotype 1, Genotype 2, Genotype 3
- Medical subject headings
- Hepatitis C, Hepatitis
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 tablets were administered orally once daily.
Placebo to match sofosbuvirDrug
Placebo tablets to match sofosbuvir were administered orally once daily.
PEGDrug
Also called Pegasys®
Pegylated interferon alfa-2a (PEG) 180 μg was administered once weekly by subcutaneous injection.
RBVDrug
Also called Copegus®
Ribavirin (RBV) was administered as a tablet orally according to package insert dosing recommendations (Genotype 1: < 75kg = 1000 mg and ≥ 75 kg = 1200 mg; Genotype 2/3: 800 mg).
| Study group | Role | What they receive |
|---|---|---|
| Sofosbuvir 200 mg (Genotype 1) | Experimental | Participants with genotype 1 HCV infection were randomized to receive sofosbuvir 200 mg (2 x 100 mg tablets)+placebo to match sofosbuvir (2 tablets)+PEG+RBV for 12 weeks followed by PEG+RBV for up to an additional 36 weeks. Receives: Drug: Sofosbuvir; Drug: Placebo to match sofosbuvir; Drug: PEG; Drug: RBV |
| Sofosbuvir 400 mg (Genotype 1) | Experimental | Participants with genotype 1 HCV infection were randomized to receive sofosbuvir 400 mg (4 x 100 mg tablets)+PEG+RBV for 12 weeks followed by PEG+RBV for up to an additional 36 weeks. Receives: Drug: PEG; Drug: RBV |
| Placebo (Genotype 1) | Active comparator | Participants with genotype 1 HCV infection were randomized to receive placebo to match sofosbuvir (4 tablets)+PEG+RBV for 12 weeks followed by PEG+RBV for up to an additional 36 weeks. Receives: Drug: Placebo to match sofosbuvir; Drug: PEG; Drug: RBV |
| Sofosbuvir 400 mg (Genotype 2/3) | Experimental | Participants with genotype 2 or 3 HCV infection received sofosbuvir 400 mg (4 x 100 mg tablets)+PEG+RBV for 12 weeks. Receives: Drug: Sofosbuvir; Drug: PEG; Drug: RBV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Who Experienced Adverse Events During the Sofosbuvir Treatment Period
Adverse events (AEs) occurring during the sofosbuvir treatment period and for 30 days following the last dose of sofosbuvir were summarized across the participant population. A participant was counted once if they had a qualifying event.
Measured: Baseline to Week 12 plus 30 days
Secondary outcomes (13)
Change in HCV RNA From Baseline to Week 12
Measured: Baseline to Week 12
Percentage of Participants With Rapid Virologic Response at Week 4
Rapid virologic response was defined as HCV RNA below the limit of detection (< 15 IU/mL) at Week 4 (Day 29)
Measured: Week 4
Percentage of Participants With Complete Early Virologic Response at Week 12
Complete early virologic response was defined as HCV RNA below the limit of detection (< 15 IU/mL) at Week 12
Measured: Week 12
Percentage of Participants With Extended Rapid Virologic Response
Extended rapid virologic response was defined as HCV RNA below the limit of detection (< 15 IU/mL) at Week 4 (Day 29) which was maintained through Week 12.
Measured: Week 4 to Week 12
Percentage of Participants With Virologic Response at the End of Treatment
End-of-treatment virologic response was defined as HCV RNA below the limit of detection (< 15 IU/mL) at the last on-treatment visit.
Measured: Week 48 (genotype 1) or Week 12 (genotype 2/3)
Percentage of Participants With Sustained Virologic Response at Post-treatment Week 12 (SVR12) and 24 (SVR24)
SVR12 and SVR24 were defined as HCV RNA below the limit of detection (< 15 IU/mL) at post-treatment Weeks 12 and 24, respectively.
Measured: Post-treatment Weeks 12 and 24
Plasma Pharmacokinetics of GS-331007 (Cmax at Day 8)
The pharmacokinetics of sofosbuvir metabolite GS-331007 were analyzed as the maximum observed concentration of drug in plasma (Cmax) at Day 8. Blood samples were collected at 1, 2, and 4 hours postdose for all participants, and at 8 and 12 hours postdose for participants enrolled at selected sites.
Measured: 1, 2, 4, 8, and 12 hours postdose
Plasma Pharmacokinetics of GS-331007 (Cmax at Day 15)
The pharmacokinetics of sofosbuvir metabolite GS-331007 were analyzed as the Cmax at Day 15. Blood samples were collected at 1, 2, and 4 hours postdose for all participants, and at 8 and 12 hours postdose for participants enrolled at selected sites.
Measured: 1, 2, 4, 8, and 12 hours postdose
Plasma Pharmacokinetics of GS-331007 (Cmax at Day 29)
The pharmacokinetics of sofosbuvir metabolite GS-331007 were analyzed as the Cmax at Day 29. Blood samples were collected at 1, 2, and 4 hours postdose for all participants, and at 8 and 12 hours postdose for participants enrolled at selected sites.
Measured: 1, 2, 4, 8, and 12 hours postdose
Plasma Pharmacokinetics of GS-331007 (AUCtau at Day 8)
The pharmacokinetics of sofosbuvir metabolite GS-331007 were analyzed as the the area under the plasma concentration versus time curve over the dosing interval (AUCtau) at Day 8. Blood samples were collected at 1, 2, and 4 hours postdose for all participants, and at 8 and 12 hours postdose for participants enrolled at selected sites.
Measured: 1, 2, 4, 8, and 12 hours postdose
Plasma Pharmacokinetics of GS-331007 (AUCtau at Day 15)
The pharmacokinetics of sofosbuvir metabolite GS-331007 were analyzed as the the area under the plasma concentration versus time curve over the dosing interval (AUCtau) at Day 15. Blood samples were collected at 1, 2, and 4 hours postdose for all participants, and at 8 and 12 hours postdose for participants enrolled at selected sites.
Measured: 1, 2, 4, 8, and 12 hours postdose
Plasma Pharmacokinetics of GS-331007 (AUCtau at Day 29)
The pharmacokinetics of sofosbuvir metabolite GS-331007 were analyzed as the the area under the plasma concentration versus time curve over the dosing interval (AUCtau) at Day 29. Blood samples were collected at 1, 2, and 4 hours postdose for all participants, and at 8 and 12 hours postdose for participants enrolled at selected sites.
Measured: 1, 2, 4, 8, and 12 hours postdose
Percentage of Participants Who Developed Resistance to Sofosbuvir
Resistance monitoring was completed in all subjects who received sofosbuvir and who had non-response, viral rebound, virologic breakthrough, or HCV RNA plateaus between Day 0 and Week 24.
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionApr 2011
- Study completionMay 2012
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 (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis C VirusStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gilead Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert H. Hyland, DPhil, Study director, Gilead Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01188772
- Sponsor's protocol ID
- P7977-0422
- Status last verified
- Apr 2014
- First submitted
- 23 Aug 2010
- Last updated
- 21 Apr 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Lawitz E, Lalezari JP, Hassanein T, Kowdley KV, Poordad FF, Sheikh AM, Afdhal NH, Bernstein DE, Dejesus E, Freilich B, Nelson DR, Dieterich DT, Jacobson IM, Jensen D, Abrams GA, Darling JM, Rodriguez-Torres M, Reddy KR, Sulkowski MS, Bzowej NH, Hyland RH, Mo H, Lin M, Mader M, Hindes R, Albanis E, Symonds WT, Berrey MM, Muir A. Sofosbuvir in combination with peginterferon alfa-2a and ribavirin for non-cirrhotic, treatment-naive patients with genotypes 1, 2, and 3 hepatitis C infection: a randomised, double-blind, phase 2 trial. Lancet Infect Dis. 2013 May;13(5):401-8. doi: 10.1016/S1473-3099(13)70033-1. Epub 2013 Mar 15.
PubMed 23499158
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Placebo-Controlled, Dose Ranging Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Oral Administration of PSI-7977 in Combination With Pegylated Interferon and Ribavirin in Treatment-Naïve Patients With Chronic HCV Infection Genotype 1, and an Open Label Assessment of PSI-7977 in Patients With HCV Genotypes 2 or 3
- ClinicalTrials.gov ID
- NCT01188772
- Acronym / sponsor ID
- P7977-0422
- Conditions
- Hepatitis C Virus
- Keywords
- Hepatitis C Virus, HCV, hepatitis, Genotype 1, Genotype 2, Genotype 3
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Gilead SciencesIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Apr 2011 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 25 Aug 2010 (estimated)
- Results
- Posted 19 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Genotype 1: Participants with genotype 1 hepatitis C (HCV) infection were randomized to receive sofosbuvir (GS-7977; PSI-7977) 200 mg or 400 mg, or matching placebo, plus pegylated interferon alfa 2a (PEG) and ribavirin (RBV) for 12 weeks, followed by PEG+RBV for an up to an additional 36 weeks. Randomization was stratified by IL28B status (CC, CT, TT) and HCV RNA level (< 800,000 IU/ml or ≥ 800,000 IU/ml) at baseline. Participants were randomized in a 2:2:1 manner; those who achieved an extended rapid virologic response (eRVR) (HCV RNA < lower limit of detection [15 IU/mL] from Weeks 4 through 12) received an additional 12 weeks of PEG+RBV. Subjects not achieving eRVR received an additional 36 weeks of PEG+RBV.
Genotype 2 and 3: Participants with genotype 2 or 3 hepatitis C (HCV) received sofosbuvir 400 mg plus PEG+RBV for 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Sofosbuvir 200 mg (Genotype 1) | Experimental | Drug: Sofosbuvir, Drug: Placebo to match sofosbuvir, Drug: PEG, Drug: RBVParticipants with genotype 1 HCV infection were randomized to receive sofosbuvir 200 mg (2 x 100 mg tablets)+placebo to match sofosbuvir (2 tablets)+PEG+RBV for 12 weeks followed by PEG+RBV for up to an additional 36 weeks. |
| Sofosbuvir 400 mg (Genotype 1) | Experimental | Drug: PEG, Drug: RBVParticipants with genotype 1 HCV infection were randomized to receive sofosbuvir 400 mg (4 x 100 mg tablets)+PEG+RBV for 12 weeks followed by PEG+RBV for up to an additional 36 weeks. |
| Placebo (Genotype 1) | Active comparator | Drug: Placebo to match sofosbuvir, Drug: PEG, Drug: RBVParticipants with genotype 1 HCV infection were randomized to receive placebo to match sofosbuvir (4 tablets)+PEG+RBV for 12 weeks followed by PEG+RBV for up to an additional 36 weeks. |
| Sofosbuvir 400 mg (Genotype 2/3) | Experimental | Drug: Sofosbuvir, Drug: PEG, Drug: RBVParticipants with genotype 2 or 3 HCV infection received sofosbuvir 400 mg (4 x 100 mg tablets)+PEG+RBV for 12 weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Males or females aged 18 to 70 years, inclusive, at screening
- Documented chronic genotype 1, 2, or 3 HCV infection
- No previous treatment with HCV antiviral mediations
- Body mass index (BMI) of greater than 18 kg/m2, but not exceeding 36 kg/m2.
- Liver biopsy obtained within 3 years prior to the Day 1 visit, with a fibrosis classification of non-cirrhotic as judged by a local pathologist
Key exclusion criteria (17 listed)
- Females who were breastfeeding
- Males and females of reproductive potential who are unwilling to use an "effective", protocol-specified method(s) of contraception during the study
- Positive test at Screening for HBsAg, anti-HBc IgM Ab, or anti-HIV Ab.
- History of any other clinically significant chronic liver disease
- Treatment with herbal/natural remedies with antiviral activity within 30 days prior to baseline.
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 tablets were administered orally once daily. | Drug | Sofosbuvir 200 mg (Genotype 1), Sofosbuvir 400 mg (Genotype 2/3) |
| Placebo to match sofosbuvirPlacebo tablets to match sofosbuvir were administered orally once daily. | Drug | Placebo (Genotype 1), Sofosbuvir 200 mg (Genotype 1) |
| PEGAlso: Pegasys®Pegylated interferon alfa-2a (PEG) 180 μg was administered once weekly by subcutaneous injection. | Drug | Placebo (Genotype 1), Sofosbuvir 200 mg (Genotype 1), Sofosbuvir 400 mg (Genotype 1), Sofosbuvir 400 mg (Genotype 2/3) |
| RBVAlso: Copegus®Ribavirin (RBV) was administered as a tablet orally according to package insert dosing recommendations (Genotype 1: < 75kg = 1000 mg and ≥ 75 kg = 1200 mg; Genotype 2/3: 800 mg). | Drug | Placebo (Genotype 1), Sofosbuvir 200 mg (Genotype 1), Sofosbuvir 400 mg (Genotype 1), Sofosbuvir 400 mg (Genotype 2/3) |
Primary outcome
Percentage of Participants Who Experienced Adverse Events During the Sofosbuvir Treatment Period
Time frame: Baseline to Week 12 plus 30 days
Adverse events (AEs) occurring during the sofosbuvir treatment period and for 30 days following the last dose of sofosbuvir were summarized across the participant population. A participant was counted once if they had a qualifying event.
13 secondary outcomes
Change in HCV RNA From Baseline to Week 12
Time frame: Baseline to Week 12
Percentage of Participants With Rapid Virologic Response at Week 4
Time frame: Week 4
Percentage of Participants With Complete Early Virologic Response at Week 12
Time frame: Week 12
Percentage of Participants With Extended Rapid Virologic Response
Time frame: Week 4 to Week 12
Percentage of Participants With Virologic Response at the End of Treatment
Time frame: Week 48 (genotype 1) or Week 12 (genotype 2/3)
Percentage of Participants With Sustained Virologic Response at Post-treatment Week 12 (SVR12) and 24 (SVR24)
Time frame: Post-treatment Weeks 12 and 24
Plasma Pharmacokinetics of GS-331007 (Cmax at Day 8)
Time frame: 1, 2, 4, 8, and 12 hours postdose
Plasma Pharmacokinetics of GS-331007 (Cmax at Day 15)
Time frame: 1, 2, 4, 8, and 12 hours postdose
Plasma Pharmacokinetics of GS-331007 (Cmax at Day 29)
Time frame: 1, 2, 4, 8, and 12 hours postdose
Plasma Pharmacokinetics of GS-331007 (AUCtau at Day 8)
Time frame: 1, 2, 4, 8, and 12 hours postdose
Plasma Pharmacokinetics of GS-331007 (AUCtau at Day 15)
Time frame: 1, 2, 4, 8, and 12 hours postdose
Plasma Pharmacokinetics of GS-331007 (AUCtau at Day 29)
Time frame: 1, 2, 4, 8, and 12 hours postdose
Percentage of Participants Who Developed Resistance to Sofosbuvir
Time frame: Baseline to Week 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23499158Lawitz E, Lalezari JP, Hassanein T, Kowdley KV, Poordad FF, Sheikh AM, Afdhal NH, Bernstein DE, Dejesus E, Freilich B, Nelson DR, Dieterich DT, Jacobson IM, Jensen D, Abrams GA, Darling JM, Rodriguez-Torres M, Reddy KR, Sulkowski MS, Bzowej NH, Hyland RH, Mo H, Lin M, Mader M, Hindes R, Albanis E, Symonds WT, Berrey MM, Muir A. Sofosbuvir in combination with peginterferon alfa-2a and ribavirin for non-cirrhotic, treatment-naive patients with genotypes 1, 2, and 3 hepatitis C infection: a randomised, double-blind, phase 2 trial. Lancet Infect Dis. 2013 May;13(5):401-8. doi: 10.1016/S1473-3099(13)70033-1. Epub 2013 Mar 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.
Robert H. Hyland, DPhil study director
Gilead Sciences
23 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sofosbuvir, PEG and RBV in people with Hepatitis C Virus, run by Gilead Sciences at 23 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 8 inclusion and 17 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 21 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 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 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 19 Feb 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 Who Experienced Adverse Events During the Sofosbuvir Treatment Period (time frame: Baseline to Week 12 plus 30 days). 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 NCT01188772, 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 21 Apr 2014.