AzTrials
AzTrials

Hepatitis C, ChronicPhase 2ATOMICNCT01329978

Sofosbuvir With Pegylated Interferon and Ribavirin Hepatitis C Virus (HCV) Genotypes 1,4,5,6

A Phase 2 study testing Sofosbuvir, RBV and PEG in people with Hepatitis C, Chronic, run by Gilead Sciences at 46 sites in 2 countries.

Completed

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

Official record
Search all trials

Trial summary

The purpose of this study is to assess the safety, tolerability, and efficacy of sofosbuvir (GS-7977; PSI-7977) administered in combination with pegylated interferon and ribavirin (PEG/RBV) in treatment-naive patients with HCV genotypes 1,4,5,6, or indeterminate genotype. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatitis C, Chronic
What is being tested?
Sofosbuvir, RBV and PEG
Could I receive a placebo?
No, everyone receives an active treatment
How many people
332 participants
Where
46 sitesin 2 countries
Study dates
Mar 2011to Aug 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males and females with Chronic Hepatitis C (HCV) Genotype 1,4,5,6, or indeterminate
  • Naive to previous HCV treatment

Who cannot join

  • Positive for HBsAg, anti-HBc IgM Ab, or anti-HIV Ab
  • History of any other clinically significant chronic liver disease

Trial locations and contacts

46 sites in 2 countries.

46 sites in 2 countries

United States44 sites

  • University of New Mexico Health Science Center

    Albuquerque, New Mexico, 87131

  • Advanced Clinical Research Institute

    Anaheim, California, 92801

  • Investigative Clinical Research

    Annapolis, Maryland, 21401

  • North Texas Research Institute

    Arlington, Texas, 76012

  • Asheville Gastroenterology Associates

    Asheville, North Carolina, 28801

  • Atlanta Gastroenterology Associates

    Atlanta, Georgia, 30308

  • University of Colorado Denver Transplant Center and Hepatology Clinic

    Aurora, Colorado, 80045

  • Central Texas Cinical Research

    Austin, Texas, 78705

  • Beth Israel Deconess Medical Center

    Boston, Massachusetts, 02215

  • Pointe West Infectious Disease

    Bradenton, Florida, 34209

  • Providence Clinical Research

    Burbank, California, 91505

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • Columbia Gastroenterology Associates

    Columbia, South Carolina, 29204

  • Southern California Liver Centers

    Coronado, California, 92118

  • Baylor University

    Dallas, Texas, 75246

  • Avail Clinical Research

    DeLand, Florida, 32720

  • Duke University Medical Center

    Durham, North Carolina

  • South Denver Gastreoenterology

    Englewood, Colorado, 80110

  • University of Florida College of Medicine

    Gainesville, Florida, 32610

  • Baylor/ St. Luke's Advanced Liver Therapy

    Houston, Texas, 77030

  • Clopton Clinic

    Jonesboro, Arkansas, 72401

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

  • North Shore University Hospital

    Manhasset, New York, 11303

  • Gastrointestinal Specialists of Georgia

    Marietta, Georgia, 30060

  • Alabama Liver and Digestive Specialist

    Montgomery, Alabama, 36116

  • Concorde Medical Group

    New York, New York, 10016

  • New York Presbyterian Hospital

    New York, New York, 10021

  • Mt. Sinai Medical Center

    New York, New York, 10029

  • Digestive and Liver Disease Specialist

    Norfolk, Virginia, 23502

  • Henry Ford Health System

    Novi, Michigan, 48377

  • eStudy Site

    Oceanside, California, 92056

  • Orlando Immunology Center

    Orlando, Florida, 32803

  • Internal Medicine Specialists

    Orlando, Florida, 32806

  • Clinical Associates Research

    Reisterstown, Maryland, 21136

  • Alamo Medical Research

    San Antonio, Texas, 78215

  • Desta Digestive Disease Medical Center

    San Diego, California, 92114

  • Medical Associates Reseach Group

    San Diego, California, 92123

  • Kaiser Permanente Hepatology Research

    San Diego, California, 92154

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • St. Louis University Gastroenterology and Hepatology Clinical Research

    St Louis, Missouri, 63104

  • Advanced Research Institute

    Trinity, Florida, 34655

  • South Florida Center of Gastroenterology

    Wellington, Florida, 33414

  • U Mass Memorial Medical Center

    Worcester, Massachusetts, 01655

Other trials in United States

Puerto Rico2 sites

  • University Of Puerto Rico

    San Juan, Puerto Rico, 00935

  • Fundacion de Investigacion de Diego

    San Juan, Puerto Rico

Other trials in Puerto Rico

About this study

Official title: The ATOMIC Study: A Multicenter, Open-label, Randomized, Duration Finding Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Oral Administration of PSI-7977 in Combination With Pegylated Interferon and Ribavirin in Treatment-Naive Patients With Chronic HCV Infection Genotype 1,4, 5, or 6

The purpose of this study is to assess the safety, tolerability, and efficacy of sofosbuvir (GS-7977; PSI-7977) administered in combination with pegylated interferon and ribavirin (PEG/RBV) in treatment-naive patients with HCV genotypes 1,4,5,6, or indeterminate genotype.

Being tested
Sofosbuvir, RBV, PEG
Keywords
Hepatitis C, HCV, Chronic Hepatitis C
Medical subject headings
Hepatitis C, Chronic, Hepatitis C

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 (SOF) administered as a 400 mg tablet orally once daily

  • RBVDrug

    Also called Copegus®

    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 groups in NCT01329978
Study groupRoleWhat they receive
SOF+PEG+RBV 12 weeksExperimentalParticipants were randomized to receive sofosbuvir+PEG+RBV for 12 weeks.
Receives: Drug: Sofosbuvir; Drug: RBV; Drug: PEG
SOF+PEG+RBV 24 weeksExperimentalParticipants were randomized to receive sofosbuvir+PEG+RBV for 24 weeks.
Receives: Drug: Sofosbuvir; Drug: RBV; Drug: PEG
SOF+PEG+RBV 12 week/Rerandomization GroupExperimentalParticipants were randomized to receive sofosbuvir+PEG+RBV for 12 weeks, then were rerandomized to receive sofosbuvir only or sofosbuvir+RBV for 12 additional weeks.
Receives: Drug: Sofosbuvir; Drug: RBV; Drug: PEG

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 24 Weeks Following Completion of Treatment (SVR24)

    SVR24 was defined as HCV RNA < the limit of detection (LOD; < 15 IU/mL) 24 weeks after the last dose of study drug.

    Measured: Post-treatment Week 24

  2. Percentage of Participants Who Experienced Adverse Events

    Adverse events (AEs) occurring from baseline (Day 1 for all groups) to 30 days following the last dose of study drug were summarized across the participant population. A participant was counted once if they had a qualifying event.

    Measured: Baseline (Day 1) to post-treatment Day 30

Secondary outcomes (15)

  1. Percentage of Participants With Sustained Virologic Response 12 Weeks Following Completion of Treatment (SVR12)

    SVR12 was defined as HCV RNA < LOD 12 weeks after the last dose of study drug.

    Measured: Post-treatment Week 12

  2. Change in HCV RNA at Week 2

    Measured: Baseline (Day 1) to Week 2

  3. Change in HCV RNA at Week 4

    Measured: Baseline (Day 1) to Week 4

  4. Change in HCV RNA at Week 8

    Measured: Baseline (Day 1) to Week 8

  5. Change in HCV RNA at Week 12

    Measured: Baseline (Day 1) to Week 12

  6. Percentage of Participants With HCV RNA < LOD at Week 2

    Measured: Week 2

  7. Percentage of Participants With HCV RNA Below < LOD at Week 4

    Measured: Week 4

  8. Percentage of Participants With HCV RNA Below < LOD at Week 8

    Measured: Week 8

  9. Percentage of Participants With HCV RNA Below < LOD at Week 12

    Measured: Week 12

  10. Percentage of Participants With HCV RNA Below < LOD at Week 24

    Measured: Week 24

  11. Percentage of Participants With ALT Normalization at Week 12

    ALT normalization was defined as ALT > ULN at baseline and ALT ≤ ULN at Week 12.

    Measured: Baseline (Day 1) to Week 12

  12. Percentage of Participants With ALT Normalization at Week 24

    ALT normalization was defined as ALT > ULN at baseline (Day 1 for all groups) and ALT ≤ ULN at Week 24.

    Measured: Baseline (Day 1) to Week 24

  13. Percentage of Participants With ALT Normalization at Post-treatment Week 4

    ALT normalization was defined as ALT > ULN at baseline (Day 1 for all groups) and ALT ≤ ULN at Post-treatment Week 4.

    Measured: Baseline (Day 1) to Post-treatment Week 4

  14. Percentage of Participants With Virologic Failure During Treatment

    Virologic failure was defined as either

    • HCV RNA ≥ 15 IU/mL after having previously had HCV RNA < 15 IU/mL while on treatment, confirmed with 2 consecutive values or last available measurement (ie, breakthrough);
    • > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment, confirmed with 2 consecutive values or last available measurement (ie, rebound);or
    • HCV RNA persistently ≥ 15 IU/mL through 8 weeks of treatment (ie, nonresponse)

    Baseline was Day 1 for all groups.

    Measured: Baseline (Day 1) to Week 24

  15. Percentage of Participants With Virologic Failure Following Treatment (Viral Relapse).

    Viral relapse was defined as HCV RNA < 15 IU/mL at end of treatment, confirmed with 2 consecutive values or last available 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.

  1. First posted6 Apr 2011 (estimated)
  2. Study startMar 2011
  3. Primary completionAug 2012
  4. Study completionAug 2012

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
332 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01329978
Sponsor's protocol ID
P7977-0724
Acronym
ATOMIC
Status last verified
Apr 2014
First submitted
30 Mar 2011
Last updated
26 May 2014
Data monitoring committee
No

Publications

  • Lawitz E, Poordad FF, Pang PS, Hyland RH, Ding X, Mo H, Symonds WT, McHutchison JG, Membreno FE. Sofosbuvir and ledipasvir fixed-dose combination with and without ribavirin in treatment-naive and previously treated patients with genotype 1 hepatitis C virus infection (LONESTAR): an open-label, randomised, phase 2 trial. Lancet. 2014 Feb 8;383(9916):515-23. doi: 10.1016/S0140-6736(13)62121-2. Epub 2013 Nov 5.

    PubMed 24209977

  • Kowdley KV, Lawitz E, Crespo I, Hassanein T, Davis MN, DeMicco M, Bernstein DE, Afdhal N, Vierling JM, Gordon SC, Anderson JK, Hyland RH, Dvory-Sobol H, An D, Hindes RG, Albanis E, Symonds WT, Berrey MM, Nelson DR, Jacobson IM. Sofosbuvir with pegylated interferon alfa-2a and ribavirin for treatment-naive patients with hepatitis C genotype-1 infection (ATOMIC): an open-label, randomised, multicentre phase 2 trial. Lancet. 2013 Jun 15;381(9883):2100-7. doi: 10.1016/S0140-6736(13)60247-0. Epub 2013 Mar 15.

    PubMed 23499440

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sofosbuvir, RBV and PEG in people with Hepatitis C, Chronic, run by Gilead Sciences at 46 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 2 inclusion and 2 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 26 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 46 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 26 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 With Sustained Virologic Response 24 Weeks Following Completion of Treatment (SVR24) (time frame: Post-treatment Week 24). 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 NCT01329978, which also lists 2 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 26 May 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in