- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01768286
Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin in Treatment-Experienced Subjects With Genotype 1 HCV Infection (ION-2)
October 19, 2018 updated by: Gilead Sciences
A Phase 3, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5885 Fixed-Dose Combination ± Ribavirin for 12 and 24 Weeks in Treatment-Experienced Subjects With Chronic Genotype 1 HCV Infection
This study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir/sofosbuvir fixed dose combination (FDC) with or without ribavirin (RBV) administered for 12 or 24 weeks in treatment-experienced subjects with chronic genotype 1 hepatitis C virus (HCV) infection.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
441
Phase
- 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
-
-
Arizona
-
Phoenix, Arizona, United States
-
Tucson, Arizona, United States
-
-
California
-
La Jolla, California, United States
-
Los Angeles, California, United States
-
Palo Alto, California, United States
-
San Diego, California, United States
-
San Francisco, California, United States
-
-
Colorado
-
Aurora, Colorado, United States
-
Englewood, Colorado, United States
-
-
District of Columbia
-
Washington, District of Columbia, United States
-
-
Florida
-
Gainesville, Florida, United States
-
Jacksonville, Florida, United States
-
Miami, Florida, United States
-
Orlando, Florida, United States
-
-
Georgia
-
Atlanta, Georgia, United States
-
Marietta, Georgia, United States
-
-
Illinois
-
Chicago, Illinois, United States
-
-
Indiana
-
Indianapolis, Indiana, United States
-
-
Kentucky
-
Bowling Green, Kentucky, United States
-
-
Louisiana
-
Baton Rouge, Louisiana, United States
-
-
Maryland
-
Baltimore, Maryland, United States
-
Lutherville, Maryland, United States
-
-
Massachusetts
-
Boston, Massachusetts, United States
-
Springfield, Massachusetts, United States
-
-
Michigan
-
Detroit, Michigan, United States
-
-
Minnesota
-
Rochester, Minnesota, United States
-
Saint Louis, Minnesota, United States
-
Saint Paul, Minnesota, United States
-
-
Missouri
-
Kansas City, Missouri, United States
-
-
New Jersey
-
Berlin, New Jersey, United States
-
Hillsborough, New Jersey, United States
-
-
New Mexico
-
Albuquerque, New Mexico, United States
-
Santa Fe, New Mexico, United States
-
-
New York
-
Binghamton, New York, United States
-
Manhasset, New York, United States
-
New York, New York, United States
-
-
North Carolina
-
Asheville, North Carolina, United States
-
Charlotte, North Carolina, United States
-
Durham, North Carolina, United States
-
Fayetteville, North Carolina, United States
-
Statesville, North Carolina, United States
-
Winston-Salem, North Carolina, United States
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States
-
-
Rhode Island
-
Providence, Rhode Island, United States
-
-
Tennessee
-
Germantown, Tennessee, United States
-
Nashville, Tennessee, United States
-
-
Texas
-
Arlington, Texas, United States
-
Dallas, Texas, United States
-
Houston, Texas, United States
-
San Antonio, Texas, United States
-
-
Virginia
-
Fairfax, Virginia, United States
-
Newport News, Virginia, United States
-
Norfolk, Virginia, United States
-
-
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
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age > 18, with chronic genotype 1 HCV infection
- HCV treatment-experienced, including patients who have previously failed a nonstructural protein (NS)3/4A protease inhibitor plus pegylated interferon (PEG)/RBV regimen
- HCV RNA > 10,000 IU/mL at screening
- Cirrhosis determination; a liver biopsy may be required
- Screening laboratory values within defined thresholds
- Use of two effective contraception methods if female of childbearing potential or sexually active male
Exclusion Criteria:
- Pregnant or nursing female or male with pregnant female partner
- Coinfection with HIV or hepatitis B virus
- Current or prior history of clinical hepatic decompensation
- Hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers)
- Chronic use of systemic immunosuppressive agents
- History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
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 |
Intervention / Treatment |
---|---|
Experimental: LDV/SOF 12 Weeks
Participants will receive LDV/SOF FDC for 12 weeks.
|
Ledipasvir (LDV) 90 mg/sofosbuvir (SOF) 400 mg fixed-dose combination (FDC) tablet administered orally once daily
Other Names:
|
Experimental: LDV/SOF+RBV 12 Weeks
Participants will receive LDV/SOF FDC plus RBV for 12 weeks.
|
Ribavirin (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)
Ledipasvir (LDV) 90 mg/sofosbuvir (SOF) 400 mg fixed-dose combination (FDC) tablet administered orally once daily
Other Names:
|
Experimental: LDV/SOF 24 Weeks
Participants will receive LDV/SOF FDC for 24 weeks.
|
Ledipasvir (LDV) 90 mg/sofosbuvir (SOF) 400 mg fixed-dose combination (FDC) tablet administered orally once daily
Other Names:
|
Experimental: LDV/SOF+RBV 24 Weeks
Participants will receive LDV/SOF FDC plus RBV for 24 weeks.
|
Ribavirin (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)
Ledipasvir (LDV) 90 mg/sofosbuvir (SOF) 400 mg fixed-dose combination (FDC) tablet administered orally once daily
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of Adverse Events Leading to Permanent Discontinuation From Any Study Drug
Time Frame: Up to 24 weeks
|
The percentage of participants who experienced an adverse event leading to permanent discontinuation from any study drug was summarized.
|
Up to 24 weeks
|
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, 25 IU/mL) 12 weeks following the last dose of study drug.
|
Posttreatment Week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With HCV RNA < LLOQ at Week 2
Time Frame: Week 2
|
Week 2
|
|
Percentage of Participants With HCV RNA < LLOQ at Week 4
Time Frame: Week 4
|
Week 4
|
|
Percentage of Participants With HCV RNA < LLOQ at Week 8
Time Frame: Week 8
|
Week 8
|
|
Percentage of Participants With HCV RNA < LLOQ at Week 12
Time Frame: Week 12
|
Week 12
|
|
Change From Baseline in HCV RNA at Week 2
Time Frame: Baseline; Week 2
|
Baseline; Week 2
|
|
Change From Baseline in HCV RNA at Week 4
Time Frame: Baseline; Week 4
|
Baseline; Week 4
|
|
Change From Baseline in HCV RNA at Week 8
Time Frame: Baseline; Week 8
|
Baseline; Week 8
|
|
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 SVR24 were defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug, respectively.
|
Posttreatment Weeks 4 and 24
|
Percentage of Participants With HCV RNA < LLOQ at Week 1
Time Frame: Week 1
|
Week 1
|
|
Percentage of Participants With HCV RNA < LLOQ at Week 24
Time Frame: Week 24
|
Week 24
|
|
Change From Baseline in HCV RNA at Week 1
Time Frame: Baseline; Week 1
|
Baseline; Week 1
|
|
Percentage of Participants With Virologic Failure
Time Frame: Baseline to posttreatment Week 24
|
Virologic failure was defined as on-treatment virologic failure or virologic relapse.
Virologic relapse was defined as confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit. |
Baseline to posttreatment Week 24
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Jenny Yang, PharmD, 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
- Grebely J, Mauss S, Brown A, Bronowicki JP, Puoti M, Wyles D, Natha M, Zhu Y, Yang J, Kreter B, Brainard DM, Yun C, Carr V, Dore GJ. Efficacy and Safety of Ledipasvir/Sofosbuvir With and Without Ribavirin in Patients With Chronic HCV Genotype 1 Infection Receiving Opioid Substitution Therapy: Analysis of Phase 3 ION Trials. Clin Infect Dis. 2016 Dec 1;63(11):1405-1411. doi: 10.1093/cid/ciw580. Epub 2016 Aug 23.
- Afdhal N, Reddy KR, Nelson DR, Lawitz E, Gordon SC, Schiff E, Nahass R, Ghalib R, Gitlin N, Herring R, Lalezari J, Younes ZH, Pockros PJ, Di Bisceglie AM, Arora S, Subramanian GM, Zhu Y, Dvory-Sobol H, Yang JC, Pang PS, Symonds WT, McHutchison JG, Muir AJ, Sulkowski M, Kwo P; ION-2 Investigators. Ledipasvir and sofosbuvir for previously treated HCV genotype 1 infection. N Engl J Med. 2014 Apr 17;370(16):1483-93. doi: 10.1056/NEJMoa1316366. Epub 2014 Apr 11.
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
January 1, 2013
Primary Completion (Actual)
November 1, 2013
Study Completion (Actual)
February 1, 2014
Study Registration Dates
First Submitted
January 10, 2013
First Submitted That Met QC Criteria
January 11, 2013
First Posted (Estimate)
January 15, 2013
Study Record Updates
Last Update Posted (Actual)
November 16, 2018
Last Update Submitted That Met QC Criteria
October 19, 2018
Last Verified
November 1, 2014
More Information
Terms related to this study
Keywords
- Additional relevant MeSH terms:
- Anti-Infective Agents
- HCV
- Digestive System Diseases
- Antiviral Agents
- Sustained Virologic Response
- Virus Diseases
- Hepatitis C
- Hepatitis
- Liver Diseases
- Combination Therapy
- Sofosbuvir
- Ribavirin
- Hepatitis C, Chronic
- Pharmacologic Actions
- Therapeutic Uses
- Antimetabolites
- Flaviviridae Infections
- RNA Virus Infections
- Open Label
- Molecular Mechanisms of Pharmacological Action
- HCV genotype 1 (GT-1)
- Direct Acting Antiviral
- GS-7977
- GS-5885
- Hepatitis, Chronic
- Hepatitis, Viral, Human
- Enterovirus Infections
- Picornaviridae Infections
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Hepatitis, Chronic
- Infections
- Hepatitis
- Hepatitis C
- Hepatitis C, Chronic
- Anti-Infective Agents
- Antiviral Agents
- Ledipasvir, sofosbuvir drug combination
- Ledipasvir
Other Study ID Numbers
- GS-US-337-0109
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Qualified external researchers may request IPD for this study after study completion.
For more information, please visit our website at http://www.gilead.com/research/disclosure-and-transparency.
IPD Sharing Time Frame
18 months after study completion
IPD Sharing Access Criteria
A secured external environment with username, password, and RSA code.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
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.
Clinical Trials on Chronic Hepatitis C Virus
-
AbbVieCompletedHepatitis C Virus | Chronic Hepatitis C Virus
-
Tripep ABInovio PharmaceuticalsUnknownChronic Hepatitis C Virus InfectionSweden
-
Hadassah Medical OrganizationXTL BiopharmaceuticalsWithdrawnChronic Hepatitis C Virus InfectionIsrael
-
Hadassah Medical OrganizationUnknownChronic Hepatitis C Virus InfectionIsrael
-
Beni-Suef UniversityCompletedChronic Hepatitis C Virus InfectionEgypt
-
AbbVieCompletedChronic Hepatitis C | Hepatitis C Virus | Genotype 3 Hepatitis C Virus
-
AbbVieCompletedHepatitis C Virus | Chronic Hepatitis C Virus
-
Beni-Suef UniversityCompletedChronic Hepatitis C Virus Infection
-
Beni-Suef UniversityCompletedChronic Hepatitis C Virus Infection
-
PharmaEssentiaCompletedChronic Hepatitis C Virus InfectionKorea, Republic of, Taiwan, China
Clinical Trials on RBV
-
Beijing Kawin Technology Share-Holding Co., Ltd.Completed
-
California Department of Public HealthNot yet recruiting
-
California Department of Public HealthCompleted
-
DynPort Vaccine Company LLC, A GDIT CompanyCompletedRECOMBINANT BOTULINUM VACCINE A/BUnited States
-
Beijing Kawin Technology Share-Holding Co., Ltd.CompletedChronic Hepatitis cChina
-
National Taiwan University HospitalNational Science Council, Taiwan; Department of Health, Executive Yuan, R.O...Completed
-
California Department of Public HealthCompleted
-
Bristol-Myers SquibbCompletedHepatitis CUnited States, Canada
-
Gilead SciencesCompletedChronic Hepatitis CUnited States, Canada, New Zealand, Puerto Rico
-
DynPort Vaccine Company LLC, A GDIT CompanyCompletedBotulism VaccineUnited States